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IT Shades
Engage & Enable
I-Bytes
Healthcare
July Edition 2020
Email us - solutions@itshades.com
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Table of Contents
1. Financial, M & A Updates...................................................................................................................................1
2. Solution Updates................................................................................................................................................14
3. Rewards and Recognition Updates..................................................................................................................49
4. Customer Services.............................................................................................................................................51
5. Partnership Ecosystem Updates......................................................................................................................56
6. Miscellaneous Updates.....................................................................................................................................80
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Financial, M & A
Updates Healthcare Industry
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Alexion (USA) Completes Acquisition of Portola
Alexion Pharmaceuticals, Inc. announced the successful completion of its
acquisition of Portola Pharmaceuticals, Inc. The acquisition adds Factor Xa
inhibitor reversal agent Andexxa®, marketed as Ondexxya® in Europe, to
Alexion’s commercial portfolio. Andexxa is the first and only approved
Factor Xa inhibitor reversal agent and has demonstrated transformative
clinical value by rapidly reversing the anticoagulant effects of Factor Xa
inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding.
Alexion completed the acquisition through a tender offer and subsequent
merger of Portola with Odyssey Merger Sub Inc., a wholly owned subsidiary
of Alexion. Portola is now a wholly owned subsidiary of Alexion. The tender
offer for all of the outstanding shares of common stock of Portola at a price
of $18.00 per share expired as scheduled, one minute following 11:59 p.m.,
New York City time. American Stock Transfer & Trust Company, LLC, the
depositary and paying agent for the tender offer, has advised Alexion that
62,654,962 shares of Portola common stock were validly tendered and not
validly withdrawn in the tender offer, representing approximately 79.7% of
the shares outstanding.
Executive Commentary
“This acquisition provides the opportunity to grow our commercial
portfolio, which builds on the significant progress we’ve made diversifying
our pipeline over the last few years, said Chief Executive Officer of
Alexion. We are excited to add a transformative, first-in-class medicine
like Andexxa, which rapidly reverses life-threatening bleeds that result
from Factor Xa inhibitors, to our growing critical care portfolio. This
important medicine is also a clear strategic fit with our existing expertise in
hematology and neurology, and we are confident we can apply our
demonstrated global commercial excellence to enhance access and broaden
the number of patients helped by Andexxa.”
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Financial, M&A Updates
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Centene's Illinois Subsidiary (USA) to Acquire Membership of NextLevel
Health Partners
Centene Corporation announced that its Illinois subsidiary, Meridian Health Plan of
Illinois, Inc., and NextLevel Health Partners, Inc., a health plan serving Medicaid
member in Cook County, Illinois, have entered into a Member Transfer Agreement.
Under the agreement, Meridian will be assigned 100% of NLHP's approximately
54,000 members who access benefits from the Illinois Department of Healthcare and
Family Services' HealthChoice Illinois Program. As part of the agreement, Meridian
has executed a care coordination agreement with NLHP to ensure continuity of care for
a subset of the assigned membership, effective concurrently with the closing of the
transaction. Centene provided the initial capital NLHP needed to obtain its HMO
licensure at the end of 2017, enabling a minority-owned and -operated health plan to
participate in the Illinois Medicaid program. Since then, Centene has continued to
provide operational support to NLHP. Centene Corporation, a Fortune 50 company, is a
leading multi-national healthcare enterprise that is committed to helping people live
healthier lives. The Company takes a local approach – with local brands and local
teams to provide fully integrated, high-quality, and cost-effective services to
government-sponsored and commercial healthcare programs, focusing on
under-insured and uninsured individuals.
Executive Commentary
"We are pleased to continue to support NextLevel Health Partners by entering into a
care coordination agreement, while expanding our presence in Cook County and
working with our members, providers and government partners to achieve better
health outcomes at lower costs for the state of Illinois, said President and CEO of
Centene. We look forward to leveraging our scale and continuing to grow our
relationships with these valued partners."
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Community Health Systems (USA) Announces Definitive Agreement
to Sell St. Petersburg, Florida Hospital
Community Health Systems, Inc. announced that an affiliate of the Company has signed a definitive agreement to sell
480-bed Bayfront Health St. Petersburg in St. Petersburg, Florida, and its associated assets to a subsidiary of Orlando
Health. Orlando Health will assume responsibility for the long-term lease and operations of the hospital. The lease
transfer is subject to the consent of the St. Petersburg City Council. The transaction is expected to close by the end of
the third quarter this year, subject to regulatory approvals and closing conditions. The hospital in this transaction is
among the additional potential divestitures discussed on the Company’s first quarter 2020 earnings call. Community
Health Systems, Inc. is one of the largest publicly traded hospital companies in the United States and a leading operator
of general acute care hospitals in communities across the country. The Company, through its subsidiary, owns, leases or
operates 99 affiliated hospitals in 17 states with an aggregate of approximately 16,000 licensed beds. The Company’s
headquarters are located in Franklin, Tennessee, a suburb south of Nashville.
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DSM (Netherland) issues €1 billion long-term bonds to finance acquisition
of Erber Group
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces the successful
launch of €1 billion bonds, in two tranches: a €500m bond with an eight-year maturity due in 2028, at a coupon of
0.25%, and a €500m bond with a twelve-year maturity due in 2032, at a coupon of 0.625%. The new bond issues take
advantage of favorable market conditions and allow the company to lock in low interest rates to finance the recently
announced acquisition of Erber Group. The terms are laid down in the €5 billion Debt Issuance Program of Royal
DSM, the final terms and the supplements thereto being available here. The re-offer price for the eight-year bond
tranche was 99.653%. Based on this price the yield is 0.294%. The re-offer price for the twelve-year bond tranche was
99.128%. Based on this price the yield is 0.701%. The bonds will shortly be listed on Euronext Amsterdam. This
release does not constitute an offer or an invitation to subscribe for or purchase any securities. The notes are being
offered only by means of a prospectus.
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Illumina (USA) Acquires BlueBee to Accelerate Processing, Analysis and Sharing
of Next Generation Sequencing Data at Scale
Illumina, Inc. is enhancing its capabilities to analyze and interpret the data produced by
its sequencing systems with the acquisition of BlueBee, a cloud-based software
company that provides genomics analysis solutions for research and clinical customers.
Based in the Netherlands, BlueBee has developed a regulatory compliant, secure cloud
platform that simplifies access to data and tools, enabling users to easily extract
insights from genomic data. This cloud capability is expected to lower the cost of
storing, sharing and managing the enormous volumes of genomic data that streams
from Illumina’s installed base of more than 15,000 sequencing systems. he integration
of BlueBee’s capabilities into Illumina’s cloud portfolio will give users the flexibility to
run their own custom analyses or access industry leading options such as the DRAGEN
™ Bio-IT Platform, streamlining data processing and increasing their operational
efficiency. Users also will be able to aggregate, explore and collaborate on data and
methods directly in the cloud through a user-friendly, ISO-compliant, flexible interface.
BlueBee’s capabilities include intuitive analysis management, multi-modal data
management, and data science and AI tools, as well as integrated business analytics,
and multi-cloud or on-premise deployment modes. This is a substantial addition to
Illumina’s cloud software portfolio which includes BaseSpace™ Sequencing Hub, one
of the most widely utilized software for sequencing run management and data sharing.
Executive Commentary
“We are thrilled to welcome the BlueBee team to Illumina, and excited by the
promise of delivering a streamlined way for users to analyze, explore and securely
manage large scale genomics data, said Senior Vice President of Product
Development at Illumina. Combining BlueBee and Illumina software products
provides the most scalable, efficient and extensible genomic analysis solutions for
both clinical and translational research use cases. BlueBee truly brings unique
capabilities, while ensuring secure deployment of clinical informatics across the
globe, and together we hope to deliver an unprecedented learning environment in
order to unlock the full potential of genomic insights.”
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Merck (USA) Animal Health Completes Acquisition of U.S. Rights to SENTINEL®
Brand of Combination Parasiticides for Companion Animals
Merck Animal Health, known as MSD Animal Health outside the United States and
Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA announced the
completion of its previously announced acquisition of the U.S. rights to SENTINEL®
FLAVOR TABS® and SENTINEL® SPECTRUM® Chews in the Companion Animal
category from Virbac. Comprehensive parasite protection is an essential part of canine
overall health and well-being. For more than a century, Merck, a leading global
biopharmaceutical company, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases. Merck Animal Health,
a division of Merck & Co., Inc., Kenilworth, N.J., USA, is the global animal health
business unit of Merck. Through its commitment to TheScience of Healthier Animals®,
Merck Animal Health offers veterinarians, farmers, pet owners and governments one of
the widest ranges of veterinary pharmaceuticals, vaccines and health management
solutions and services as well as an extensive suite of digitally connected identification,
traceability and monitoring products. Merck Animal Health is dedicated to preserving
and improving the health, well-being and performance of animals and the people who
care for them. It invests extensively in dynamic and comprehensive R&D resources and
a modern, global supply chain.
Executive Commentary
Comprehensive parasite protection is an essential part of canine overall health and
well-being. Our veterinary medicines, including parasiticides, and vaccines continue
to transform the animal health industry and further solidify our position in the U.S.
Companion Animal category, said President, Merck Animal Health. The extensive
breadth and depth of our product portfolio enhances our offerings of comprehensive
pet care solutions, which provide a full range of complementary solutions for our
customers to improve the health and well-being of animals and the people who care
for them.”
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Merck (USA) Completes Acquisition of Themis
Merck, known as MSD outside the United States and Canada, announced the completion of the acquisition of Themis, a
privately-held company focused on vaccines and immune-modulation therapies for infectious diseases and cancer. The U.S.
Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 and Merck has received merger control clearance from the Austrian Federal Competition Authority.
Themis is now a wholly-owned subsidiary of Merck. An initial focus of this agreement is acceleration of the development of a
measles vector-based SARS-CoV-2 vaccine candidate. This candidate is currently in pre-clinical development, and clinical
studies are planned to start later in 2020. Themis developed a broad pipeline of vaccine candidates and immune-modulatory
therapies using its innovative measles virus vector platform based on a vector originally developed by scientists at the Institut
Pasteur, a world-leading European vaccine research institute, and licensed exclusively to Themis for select viral indications. In
March, Themis joined a consortium together with the Institut Pasteur and The Center for Vaccine Research at the University of
Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations, to develop a vaccine candidate
targeting SARS-CoV-2 for the prevention of COVID-19.
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Merck (USA) Animal Health Completes Acquisition of Quantified Ag®
Merck Animal Health, known as MSD Animal Health outside the United States and
Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA announced the
completion of its acquisition of Quantified Ag®, a leading data and analytics company
that monitors cattle body temperature and movement in order to detect illness early. In
April 2018, Merck Animal Health invested in Quantified Ag® and partially funded
their development work in data analytics in livestock. Specific terms of the agreement
were not disclosed. The announcement further positions Merck Animal Health as a
global leader in animal health, broadening its portfolio in connected technology to
improve cattle health outcomes by leveraging data and analytics for animal health and
well-being. Quantified Ag®, located in Lincoln, Nebraska, provides a pro-active
system for cattle producers and feedlot operators to track an animal’s biometrics and
behavioral data through a non-invasive cattle ear tag equipped with sensors to monitor
the health of the individual animal or herd. The technology can detect animal illness,
thus reducing the potential for disease outbreak, allowing for easy identification of sick
animals, and providing easy-to-use software reports on any mobile device, desktop,
tablet or secure website. Proprietary algorithms are able to identify animals showing
signs of illness or disease and provide real-time alerts.
Executive Commentary
“We are pleased to take this step forward with Quantified Ag® as we continue to
broaden our portfolio with complementary products and technologies to advance
animal well-being for our customers, said President, Merck Animal Health. Our goal
is to improve the detection of animal illness, and the responsible use of treatments to
maintain the health of livestock. We are at the technological forefront of shaping the
future of animal health through our commitment to leveraging our scientific and
technical capabilities and expertise through comprehensive solutions to manage the
health and well-being of animals.”
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Novozymes (Denmark) acquires PrecisionBiotics Group to advance its business
within human health
Novozymes announced that it has acquired PrecisionBiotics Group Limited. Based in
Cork, Ireland, PrecisionBiotics Group holds a leading position within probiotics for
human gut health and is well positioned with several clinically backed products already
in the market. PrecisionBiotics Group has strong expertise within clinical
development, upscaling and commercialization and is well situated in Cork, Ireland,
home to a leading academic society within human gut health. Novozymes has
established OneHealth to market solutions within human health under one umbrella.
The aim is to help people live healthier and better lives by use of probiotics and
enzymes. Novozymes has acquired 100% of the equity in PrecisionBiotics Group
Limited for an amount of DKK 600 million on a cash and debt-free basis. The
transaction is structured with an earn-out model, is financed with cash and bank
facilities, and does not change the capital structure policy of Novozymes. The
acquisition gives Novozymes broader access to the overall consumer health market and
more specifically a stronger entry point into the DKK 40 billion human probiotic
supplements market which is expected to grow with a high-single-digit CAGR over the
next 3-5 years.
Executive Commentary
“This acquisition fits well with our strategy, Better business with biology, where we
have focus on human health as one of our opportunities for growth. With this
investment, we take another important step in implementing the strategy and setting
a foundation of growth for our business,” says President and CEO of Novozymes.
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Quest Diagnostics (USA) to Expand in Indiana with Acquisition of Outreach Lab Businesses of Community
Health Network and Ascension St. Vincent Now Serviced Through Mid America Clinical Laboratories
Quest Diagnostics, the world's leading provider of diagnostic information services,
announced the formation of a definitive multi-pronged agreement designed to optimize
the delivery of high quality, innovative diagnostic laboratory services in Indiana.
Through this all-cash equity transaction, Quest will acquire its joint venture partners'
interests in Mid America Clinical Laboratories and operate the business by itself.
Formed about 20 years ago as a joint venture company by Quest Diagnostics,
Ascension St. Vincent and Community Health Network, MACL is now the largest
independent clinical laboratory provider in Indiana. Upon closing, Quest will wholly
own MACL's laboratory in Indianapolis and approximately 50 patient service centers
across Indiana. As part of the transaction, Quest will also provide professional hospital
lab services under long-term service agreements for approximately 30 hospital labs
owned and operated by Ascension St. Vincent and Community Health Network.
AmeriPath Indiana will continue to provide specialized pathology services to CHN and
Ascension St. Vincent as well as to the broader community in Indiana, Assuming the
transaction's completion, providers and patients will benefit from direct access to
Quest's broader, high quality and innovative test services in Indiana.
Executive Commentary
"This transaction delivers on our accelerate growth and operational excellence
strategies, which focus on strategically aligned, accretive acquisitions, while
bolstering our professional lab services, said Quest Diagnostics Chairman, CEO and
President. Health systems increasingly turn to Quest Diagnostics to optimize their
lab strategies. We are pleased to take this step forward to deliver actionable
diagnostic insights to more patients and providers in Indiana."
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Sanofi (France) invests to make France its world class center of excellence in vaccine
research and production
Sanofi detailed plans on how the Company will make significant investments in France
to increase its vaccines research and production capacities, and contribute in
responding to future pandemic risks. Aligned with its corporate strategy presented last
December, Sanofi will invest €610 million to create a new production site and research
center in France with both dedicated to vaccines. Sanofi will invest in vaccine
production in France and create its Evolutive Vaccine Facility in Neuville sur Saône.
This state-of-the-art industrial site will utilize the latest innovative vaccine production
technologies. The project represents an investment of €490 million over a five-year
period, and is expected to create 200 new jobs. Sanofi’s investment has been made
possible thanks to the support and the close collaboration with French authorities over
the last few months. The building of this plant will enable Sanofi Pasteur, Sanofi's
global entity dedicated to vaccines, to be the first pharmaceutical manufacturer to
benefit from such an industrial tool and to secure vaccine supplies in the event of new
pandemics. EVF is a new type of factory designed around a central unit housing several
fully digital production modules that make it possible to produce three to four vaccines
simultaneously, versus only one in current industrial sites. This modularity will make it
possible to prioritize the production of a specific vaccine in a more timely manner
based on public health issues.
Executive Commentary
“Sanofi’s heart beats in France. We have a long history and exceptional teams
working throughout the country, embodying our strong values. By investing in a new
industrial site and a R&D center, Sanofi positions France at the core of its strategy,
aiming to make France a world-class center of excellence in vaccine research and
production, said Chief Executive Officer at Sanofi. Sanofi is a major healthcare
player in France, in Europe, and worldwide. It is our responsibility to focus our
resources and expertise against the current pandemic, but also to invest in preparing
for future ones. We welcome the ongoing collaboration and commitment of the
French authorities who we have been working alongside with the last several months
to achieve this.”
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Financial, M&A Updates
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Walgreens Boots Alliance (USA) Reports Fiscal 2020 Third Quarter Results
Highlights
• Sales increased 0.1 percent to $34.6 billion, up 1.2 percent on a constant currency basis, led by Retail
Pharmacy USA comparable sales growth of 3.0 percent
• Operating loss of $1.6 billion, compared to operating income of $1.2 billion a year ago, mainly due to
the non-cash impairment charges of $2 billion in Boots UK; Adjusted operating income decreased 46.5
percent to $919 million on a reported basis, down 46.4 percent on a constant currency basis
• Loss per share was $1.95, compared to EPS of $1.13 a year ago; Adjusted EPS decreased 43.8 percent
from $1.47 to $0.83, down 43.4 percent on a constant currency basis; Results reflect $0.61 to $0.65 per
share estimated operational impact from COVID-19 Adverse sales impact of approximately $700 million
to $750 million, almost entirely from the company's non-U.S. businesses
• Gross margin adversely impacted by shift from higher to lower margin categories, supply chain costs
• SG&A increased due to higher employee costs and social distancing and cleaning expenses
• Both operating income and adjusted operating income included an adverse impact of $700 million to
$750 million from the above items, or $0.61 to $0.65 per share, excluding impairment charges
• Most significant COVID-19 impact was in UK market, requiring a review resulting in non-cash
impairment charges of $2 billion
• Company took actions to partly mitigate COVID-19 impacts
Executive Commentary
Executive Vice Chairman and CEO said, “Prior to the pandemic our financial performance for fiscal
2020 was on track with our expectations. However, this unprecedented global crisis led to a loss in the
quarter as stay-at-home orders affected all of our markets. I'm very proud of how all of our teams
mobilized and adapted to deliver essential services in our communities across the world. Shopping
patterns are evolving more rapidly than ever as consumers further embrace digital options, spurring us
to accelerate our ongoing investments in digital transformation and neighborhood health destinations.
This includes our two recent announcements: a significant expansion of our primary care clinics
collaboration with VillageMD, and our strategic partnership with Microsoft and Adobe to launch a
personalized omnichannel healthcare and shopping experience.”
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Key Financial Highlights
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Zoetis (USA) Acquires Fish Vet Group to Enhance Aquaculture Diagnostic Capabilities
Zoetis announced the acquisition of Fish Vet Group from Benchmark Holdings, PLC,
as a strategic addition to its Pharmaq business which develops and commercializes fish
vaccines and offers services in vaccination and diagnostics for aquaculture. Adding
Fish Vet Group grows the geographic reach and enhances the diagnostics expertise and
testing services, including environmental testing, that Pharmaq’s reference lab Pharmaq
Analytiq now can offer fish farmers in major aquaculture markets. Fish Vet Group is
headquartered in Inverness, Scotland, with diagnostic lab locations there as well as in
Norway, Ireland and Chile, where it provides veterinary services and services in
bacteriology, histology and PCR testing. To help fish producers comply with strict
environmental standards, Fish Vet Group offers surveys and analysis to monitor
potential environmental impact and inform responsible fish disease treatments as part
of a sustainable aquaculture system. Tests and accompanying analyses from Fish Vet
Group help producers to check the impact of existing fish farms and inform the
potential for new site locations, determine and monitor seabed conditions, and provide
input to required regulatory submissions. Comprehensive lab analysis includes marine
and freshwater benthic taxonomy, sediment chemistry and water quality analysis.
Executive Commentary
“Raising healthy fish to meet the demands of our growing global population while
respecting the environment is critical for a healthier, more sustainable future, said
Executive Vice President and President of International Operations, for Zoetis.
Innovative fish health management tools, across the continuum of care and including
vaccines and diagnostic testing, will help us better meet the needs of our customers.
We are excited to welcome Fish Vet Group to our aquaculture team at Pharmaq and
together offer fish producers the most comprehensive suite of fish health solutions.”
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Solutions Updates
Healthcare Industry
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Allergan (USA): FDAApproves Expanded BOTOX® Label for the Treatment of
Pediatric Patients with Spasticity
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Solution Description
Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration approved a supplemental Biologics License
Application that supports expanded use of BOTOX® for the treatment of spasticity in pediatric patients 2 years of age and older, including
those with lower limb spasticity caused by cerebral palsy. This label expansion is based on Allergan and another manufacturer selectively
waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of pediatric
patients with spasticity caused by cerebral palsy. BOTOX® was first approved in June 2019 for the treatment of pediatric patients with upper
limb spasticity and in October 2019 for the treatment of pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral
palsy. BOTOX® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed
contracture. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower
limbs. The severity can range from mild to severe, often interfering with normal muscular movement and function. This can result in delayed
or impaired motor development, as well as difficulty with posture and positioning. Common causes of spasticity in children include cerebral
palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.
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Allergan (USA), an AbbVie Company, and Molecular Partners Receive Complete Response Letter
from FDA on Biologics License Application for Abicipar pegol
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Solution Description
Allergan, an AbbVie Company, and Molecular Partners, a clinical-stage biotechnology company developing a new class of custom-built
protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration has issued a Complete
Response Letter to the Biologics License Application for Abicipar pegol, a novel, investigational DARPin® therapy for patients with
neovascular age-related macular degeneration. The letter from the FDA indicates that the rate of intraocular inflammation observed following
administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular age-related macular
degeneration. AbbVie plans to meet with the FDA to discuss their comments and determine next steps. As a leader in eye care, Allergan has
discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over
125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular
surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes over a dozen
additional agents for multiple ocular conditions.
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Allergan (USA): FDAAccepts Supplemental Biologics License Application for BOTOX® for the
Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity
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Solution Description
Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration has accepted the company's supplemental biologics
license application to expand the BOTOX® prescribing information for the treatment of signs and symptoms of detrusor overactivity
associated with an underlying neurologic condition in pediatric patients who have an inadequate response to, or are intolerant of, or for any
reason unwilling to continue anticholinergic medication. The sBLA is based on data from a randomized, double-blind Phase 3 study
evaluating the safety and efficacy of BOTOX® in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term
extension study. The Prescription Drug User Fee Act date is expected to be in the first quarter of 2021 following a standard 10-month review.
Neurogenic detrusor overactivity results from the inability of the spinal cord and bladder to communicate effectively. As a result, the bladder
muscle involuntarily contracts, increasing the pressure in the bladder and reducing the bladder capacity, which can cause the individual to leak
urine frequently and unexpectedly. If not adequately managed with clean intermittent catheterization and anticholinergic drugs, this condition
may require augmentation cystoplasty to prevent renal damage.
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Allergan (USA): FDAApproves JUVÉDERM® VOLUMA™ XC for Enhancement of the
Chin Region
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17
Solution Description
Allergan Aesthetics, an AbbVie company, announced the FDA approval of JUVÉDERM® VOLUMA™ XC for the augmentation of the chin
region to improve the chin profile in adults over the age of 21.1 As the category leader, the JUVÉDERM® Collection of Fillers has the
broadest portfolio of specifically tailored treatment options, and this latest approval marks their fifth approved indication in the U.S.1-5.
JUVÉDERM® VOLUMA™ XC is the first and only filler to receive U.S. FDA approval for the augmentation of the chin region.1 This
approval marks the second indication for the product, which was previously approved by the FDA in 2013 for cheek augmentation to correct
age-related mid-face volume deficit. JUVÉDERM® VOLUMA™ XC is currently the number one product in the JUVÉDERM® portfolio in
the U.S. and lasts up to two years with optimal treatment for cheek augmentation. At Allergan Aesthetics, an AbbVie company, they develop,
manufacture, and market a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body
contouring, plastics, skin care, and more. Their goal is to consistently provide their customers with innovation, education, exceptional service,
and a commitment to excellence, all with a personal touch.
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CVS Pharmacy (USA) introduces new app feature for reading “talking” prescription labels
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18
Solution Description
CVS Pharmacy announced that it has developed Spoken Rx, a new feature of the CVS Pharmacy app that can read a specific type of
label for patients with visual impairments and those who cannot read standard print labels. Spoken Rx is the first in-app prescription
reader application to be developed by a national retail pharmacy. By the end of 2020, 1,500 CVS Pharmacy locations will be equipped
to affix special RFID labels to prescription vials. When the RFID labels are scanned by Spoken Rx in the CVS Pharmacy app, which
can be accessed by users using Siri or Google Assistant on their phones, prescription label information will be spoken out loud. This
information, which is important for patient safety and adherence, currently includes patient name, medication name, dosage and
directions and will be enhanced to include additional information over the months to come. Spoken Rx will be available in all CVS
Pharmacy locations by the end of 2021. Enrollment in the program is seamless and can be done either over the phone or in store where
a pharmacist can ensure the patient's app is appropriately set up for the service. Spoken Rx is free to CVS Pharmacy patients and the
app will read prescription label information aloud in either English or Spanish.
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Allergan (USA): ULTOMIRIS® Receives Marketing Authorization from European Commission
for Adults and Children with Atypical Hemolytic Uremic Syndrome
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19
Solution Description
Alexion Pharmaceuticals, Inc. announced that the European Commission has approved ULTOMIRIS® the first and only long-acting
C5 complement inhibitor administered every eight weeks for the treatment of adults and children with a body weight of 10 kg or
above with atypical hemolytic uremic syndrome who are complement inhibitor treatment-naïve or have received SOLIRIS® for at
least three months and have evidence of response to eculizumab. Atypical HUS is an ultra-rare disease that can cause progressive
injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. Atypical HUS affects both
adults and children and many patients present in critical condition in the hospital setting, often requiring supportive care, including
dialysis, in an intensive care unit. The prognosis of aHUS can be poor in many cases, with 56 percent of adults and 29 percent of
children developing end-stage renal disease or dying within a year of diagnosis with supportive care alone,3 so a timely and accurate
diagnosis – in addition to treatment – is critical to improving patient outcomes.
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BD (USA) Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15
minutes, Dramatically Expanding Access to COVID-19 Testing
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20
Solution Description
BD, a leading global medical technology company, announced that the U.S. Food and Drug Administration granted Emergency Use
Authorization for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor™ Plus System.
The launch of this new assay that delivers results in 15 minutes on an easy-to-use, highly portable instrument is critical for improving
access to COVID-19 diagnostics because it enables real-time results and decision making while the patient is still onsite. The BD
Veritor™ System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent
care centers and retail pharmacies in all 50 U.S. states. Its one-button functionality, workflow flexibility, and ease-of-use make it an
ideal solution for settings without laboratory personnel. It also offers customers real-time reporting capabilities through the BD
Synapsys™ informatics solution providing them with the ability to easily report data for disease monitoring and surveillance
purposes. BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2
million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through
September.
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Boston Scientific (USA) Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac
Monitor System
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21
Solution Description
Boston Scientific has received U.S. Food and Drug Administration 510(k) clearance for the LUX-Dx™ Insertable Cardiac Monitor
System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial
fibrillation, cryptogenic stroke and syncope. The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and
then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.
Further, the remote programming capabilities of the device via the LATITUDE Clarity™ Data Management System website allow
physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable
on any other ICM currently on the market. The dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify
AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes and allows the device to detect arrhythmias each time
established thresholds or parameters are exceeded. An additional level of verification filters is then applied, which was developed to
catch false positive detections before an alert is sent. Additionally, after implant, patients are provided with a mobile device preloaded
with the MyLUX™ app which connects via Bluetooth® to their ICM device. The app transmits device data daily, or as needed, to the
LATITUDE Clarity Data Management System giving physicians and care teams timely access to vital information.
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Bristol Myers Squibb (USA): European Commission Approves Reblozyl for the Treatment of Transfusion-Dependent
Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia
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22
Solution Description
Bristol Myers Squibb and Acceleron Pharma Inc. announced that the European Commission has approved Reblozyl for the treatment of:
• Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes with ring
sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.
• Adult patients with transfusion-dependent anemia associated with beta thalassemia.
MEDALIST is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of Reblozyl
plus best supportive care versus placebo plus BSC in adults with IPSS-R-defined very low-, low- or intermediate-risk non-del MDS. All
patients were RBC transfusion-dependent and were either refractory or intolerant to prior erythropoiesis stimulating agent therapy, or were
ESA naïve and unlikely to respond due to endogenous serum erythropoietin levels of ≥ 200 U/L, and had no prior treatment with disease
modifying agents. The trial showed a statistically significant improvement in RBC transfusion burden with Reblozyl, the study’s primary
endpoint, with 37.9% of patients treated with Reblozyl achieving independence from RBC transfusions for at least eight weeks during the first
24 weeks of the trial compared to 13.2% of patients on placebo.
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DSM (Netherland) debuts integrated portfolio of solutions for winning plant-based meat alternatives
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23
Solution Description
Royal DSM unveils its complete portfolio of integrated solutions for creating stand-out plant-based meat alternatives. The range is designed
to enhance taste, texture and nutritional value, while also managing sodium content in meat alternative applications such as burgers, sausages
and nuggets. Featuring a selection of yeast extracts, process flavors, hydrocolloids and nutritional ingredients, DSM’s full portfolio provides
food producers with the tools they need to get to this thriving market fast, and meet growing consumer demand for an authentic, enjoyable
and nourishing meat alternative experience. While the demand for meat continues to grow, the retail value of meat alternatives is expected to
more than double this decade. However, as the trend gains traction, consumer expectations and preferences are becoming more sophisticated.
It is no longer enough that a product is plant-based. Consumers are increasingly looking for an end-to-end experience that offers great taste,
compelling texture and mouthfeel, as well as a rich nutritional profile. Meanwhile, they expect reduced levels of sodium in their foods – which
is typically present in high quantities in meat alternative products. This presents a range of complex challenges for manufacturers in this space.
DSM’s combined ingredient capabilities in taste, texture and nutrition not only enable meat alter-native producers to optimize the
cost-performance ratio of their recipes, but also amplify front-of-pack claims thanks to DSM’s deep-rooted expertise into nutrition science.
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Eisai (Japan) To Launch In-House Developed New Anti-Insomnia Drug Dayvigo® With Indication for
Insomnia in Japan
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24
Solution Description
Eisai Co., Ltd. announced that it has launched its in-house-discovered and developed orexin receptor antagonist DAYVIGO® 2.5 mg, 5
mg, 10 mg tablets for treatment of insomnia in Japan. Eisai received marketing and manufacturing approval for this formulation on
January 23, 2020, and the product was added to Japan’s National health Insurance drug price list. DAYVIGO is a dual orexin receptor
antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin
receptors. DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake
by regulating sleep-wake rhythm. The approval of DAYVIGO in Japan is based on findings from two pivotal Phase III studies1,2 in adult
patients with insomnia, as well as evaluation of residual effects including middle of the night waking, next morning postural stability, and
memory through Studies 1063 and 1084.
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Eisai (Japan): New Fine Granule Formulation of Anti-Epileptic Drug Fycompa® Launched in
Japan
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25
Solution Description
Eisai Co., Ltd. announced that it has launched a new fine granule formulation of its in-house-discovered antiepileptic drug Fycompa® in
Japan. Eisai received marketing and manufacturing approval for this formulation, and the fine granule formulation was added to Japan’s
National Health Insurance drug price list of the same year. In Japan, it is estimated that there are approximately 1 million patients with
epilepsy. While epilepsy is a disease that may occur regardless of age, it is said that incidence is particularly high in children and the
elderly. This newly launched fine granule formula was developed so that even patients who have difficulty taking tablets such as children
or those who have difficulties in taking tablets due to reduced swallowing ability may take this drug. Additionally, greater ability to adjust
dosage to match patients’ symptoms becomes possible. Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research
Laboratories and was developed in-house. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal
hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. In Japan, Fycompa is currently
approved for monotherapy and adjunctive use in the treatment of partial-onset seizures in patients with epilepsy 4 years of age and older,
as well as adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
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Eisai (Japan) Receives Approval for Parkinson’s Disease Treatment Equfina® In South Korea
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26
Solution Description
Eisai Co., Ltd. announced that Eisai Korea Inc., Eisai’s subsidiary in South Korea, has received marketing approval of Parkinson’s disease
treatment Equfina® for the indication of treatment of idiopathic Parkinson’s disease as adjunctive therapy with levodopa-containing
products in patients with end of dose motor fluctuations from the regulatory authority in South Korea. The marketing authorization
application for safinamide in South Korea was submitted in July 2019, and through the approval of this application, South Korea became
the first country in Asia outside of Japan to grant marketing approval for safinamide. This approval is primarily based on a double-blind,
placebo-controlled, phase III study in overseas countries, including South Korea, to evaluate the efficacy and safety of 24-week oral
administration of the once-daily safinamide as an add-on to levodopa in patients with Parkinson’s disease with motor fluctuations. In the
SETTLE study, the primary endpoint was the change in mean daily “on” time from baseline to 24 weeks of the treatment phase.
Regarding the primary endpoint, safinamide increased the “on” time by 0.96 hours more than placebo, showing a statistically significant
extension in “on” time. The most common three adverse drug reactions observed with patients with safinamide were dyskinesia, nausea
and somnolence.
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Kite (USA) Receives European Medicines Agency Approval for CAR T Cell Therapy Manufacturing
Facility in Europe
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27
Solution Description
Kite, a Gilead Company announced it has received approval to implement a variation to the Yescarta® Marketing Authorization from the
European Medicine Agency for end-to-end manufacturing. With this approval, Kite’s European manufacturing facility, designed and
dedicated to the manufacture of individualized cell therapies, is now fully operational. Kite has nearly 90 qualified treatment centers in
16 countries across Europe and Israel. The new European facility sits next to one of Europe’s largest airports, Amsterdam Airport
Schiphol. This central location, with its transport links to the region, will reduce the delivery time to and from treatment centers. The
facility has the capacity to produce therapy for up to 4,000 patients per year. As the leader in engineered cell therapy, Kite has set a
standard with an integrated state-of-the-art global manufacturing network that includes commercial manufacturing facilities in El
Segundo, California and Amsterdam, and clinical manufacturing in Santa Monica, California and Gaithersburg, Maryland. Kite is also
building a third commercial cell therapy manufacturing facility in Frederick County, Maryland, which will significantly expand the
company’s ability to manufacture CAR T cell therapies. In addition to producing novel CAR T cell therapies, the clinical manufacturing
network is also producing investigational T cell receptor therapies for evaluation in solid tumors.
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ViiV Healthcare (USA) announces US FDA approval for Rukobia, a first-in-class treatment for HIV
in adults with few treatment options available
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28
Solution Description
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders,
announced that the US Food and Drug Administration has approved Rukobia, 600 mg extended-release tablets. Rukobia is a novel
attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral therapies in heavily
treatment-experienced adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance,
intolerance or safety considerations. Significant advances over the past few decades have dramatically improved HIV treatment and for
many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living
with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at
risk of progressing to AIDS and death and in great need of additional therapies. The approval was supported by data from the phase III
BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy in HTE adults
living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomized cohort, 60% of
individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically
meaningful improvements to CD4+ T-cell count through Week 96.
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GSK (UK) receives first regulatory approval for Duvroq in Japan for patients with anaemia due to
chronic kidney disease
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29
Solution Description
GlaxoSmithKline plc announced the approval of a Japanese New Drug Application by the Ministry of Health, Labour and Welfare for
Duvroq tablets, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of patients with anaemia due to chronic
kidney disease. Anaemia is common in patients with CKD because the kidneys no longer produce adequate amounts of erythropoietin, a
hormone involved in prompting the production of red blood cells.1 HIF-PHIs are a new class of drug that trigger the body’s adaptations
to hypoxia (i.e. oxygen deprivation) and encourages the bone marrow to make more red blood cells and so reduce anaemia, thereby
benefitting patients. The JNDA was primarily based on positive data from the phase III programme conducted in Japan. The studies
evaluated Duvroq for the treatment of anaemia in patients across the spectrum of CKD from stages 3-5. This included patients on dialysis,
including both hemo- and peritoneal dialysis, and those not on dialysis, regardless of prior anaemia treatment with
erythropoiesis-stimulating agents. In contrast to current standard of care in patients with CKD which requires injections, Duvroq offers
convenience with oral administration and flexibility with once-daily dosing for dialysis and non-dialysis patients.
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Henry Schein Medical (USA) Announces Expansion of Medpod’s Telemedicine Solutions
with Integration of VisualDx
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30
Solution Description
Henry Schein Medical, the U.S. medical business of Henry Schein, Inc. and exclusive distributor of Medpod, Inc.’s telemedicine
solutions, announced the integration of VisualDx - a clinical decision support system - with Medpod’s technology infrastructure to help
health care professionals better diagnose patients virtually. VisualDx is designed to enhance diagnostic accuracy, aid therapeutic
decisions, and improve patient care, all critically important to health care professionals on the front lines of medicine. Medpod’s
cloud-based software and modular infrastructure gives providers and operators the ability to deliver customizable, high-quality, and
convenient care that meets the needs of patients who cannot visit a traditional office setting. With the integration of VisualDx’s clinical
support, Medpod users can access a database of information written by a variety of medical experts; recognize disease variants; identify
drug adverse events; and enhance patient education to help provide informed, accurate, and fast decision-making. The platform also
assists users to make custom diagnoses as a result of having the ability to enter patient-specific information, such as age range, gender,
symptoms and signs; search by disease for quick therapy and treatment options; review and compare a curated medical image library;
enhance understanding of medication reactions; and share patient handouts via email. Clinicians can also earn Continuing Medical
Education credits each time they use VisualDx as part of their subscription.
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Illumina (USA) Launches TruSight Software Suite to Accelerate the Identification of
Genetic Diseases
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31
Solution Description
Illumina, Inc. is bringing turn-key data analysis solutions to accelerate and facilitate the adoption of whole-genome sequencing with the launch of
the TruSight™ Software Suite. TruSight Software delivers ready-made infrastructure to realize the full potential of whole-genome sequencing for
rare genetic diseases. This new offering enables sample-to-report analysis for genetic disease testing, giving customers an integrated solution that
focuses on one of the most challenging parts of the workflow, empowering researchers to go from 5 million variants to a small handful, in a rapid,
scalable way. TruSight Software will make it easier for people to benefit from the valuable insights enabled by genomic sequencing. More than
250 million people are affected by rare genetic diseases globally. These conditions can be debilitating with families frequently spending upwards
of five years being referred from doctor to doctor, enduring a diagnostic odyssey often fraught with misdiagnoses, inappropriate treatments and
procedures, all in search for an underlying cause. These diagnostic odysseys are expensive. In the U.S. alone it is estimated that pediatric genetic
diseases cost at least $14 billion every year. And, in some cases it’s a race against time, where an early diagnosis can dramatically improve patient
outcomes – potentially even helping a young child live a healthier, fuller life. As one of the most comprehensive genetic tests available,
whole-genome sequencing offers the potential to shorten the time and reduce the cost of identifying these genetic conditions, and the most likely
to end the diagnostic odyssey.
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Johnson & Johnson (USA) Announces European Commission Approval for Janssen’s
Preventive Ebola Vaccine
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32
Solution Description
Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’
Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is now collaborating with the World Health
Organization on vaccine pre-qualification, which should help accelerate registration of its preventive Ebola vaccine regimen in African countries
and facilitate broader access to those most in need. Two Marketing Authorisation Applications were submitted to the European Medicines Agency
for the vaccines composing the two-dose regimen, Zabdeno® and Mvabea®. Marketing Authorisation under exceptional circumstances has been
granted following Accelerated Assessment of the MAAs and a positive opinion by the EMA’s Committee for Medicinal Products for Human Use.
Janssen’s Ebola vaccine regimen is indicated for active immunization for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus
species in individuals aged one year and above. The worst Ebola outbreak to date was the West African epidemic, which caused nearly 30,000
cases and more than 11,000 deaths in 2014-2016. There are two outbreaks currently ongoing in the Democratic Republic of the Congo, the first of
which began in 2018 and is the world’s second worst Ebola outbreak on record.
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LabCorp (USA) Launches First Digital COVID-19 Service That Improves the Doctor
and Patient Experience
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33
Solution Description
LabCorp launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital service aimed at helping doctors protect
patients by testing them for COVID-19 before surgeries and other important treatments. The service received Emergency Use Authorization by the
U.S. Food and Drug Administration. The service enables a doctor to directly order a LabCorp At Home COVID-19 test collection kit for their
patient through a digital interface with LabCorp. Once the order is placed, LabCorp will send the COVID-19 kit to the patient, who will perform
the sample collection using a nasal swab and send it back to LabCorp via FedEx. LabCorp will then deliver the patient’s test results to the
healthcare provider’s electronic medical record (EMR) and the patient’s LabCorp Patient Portal, making the process seamless for the doctor and
patient. The result provides the doctor the information needed to make the appropriate clinical decision prior to proceeding with surgery or other
treatment. LabCorp is piloting the service with select providers initially, and plans to make the service available to more health systems, hospitals,
and surgical centres through the providers’ EMRs in coming weeks.
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LabCorp (USA) Introduces Xcellerate® COVID-19 Clinical Study Solution
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34
Solution Description
LabCorp., a leading global life sciences company that is deeply integrated in guiding patient care, announced that Covance, its drug development
business, has deployed the Xcellerate® COVID-19 solution as part of its award-winning Xcellerate platform. Covance has developed a
comprehensive approach to reinitiate ongoing research and start up new studies, with a focus on patient safety and study delivery. Designed in
conjunction with Covance’s COVID-19 Operational Recovery Team, the Xcellerate® COVID-19 solution offers integrated data collection,
actionable views of critical study data, COVID-19 targeted risk management and recovery assessment. Global clinical research has been disrupted
by the COVID-19 pandemic. Specific impacts include studies being halted or paused and enrollment being delayed. Many clinical research sites
around the world have restricted all but essential visits except for patient safety, with study monitoring conducted remotely where possible. As
healthcare conditions improve globally, research sites are positioned to resume studies. The Xcellerate COVID-19 solution reinforces Covance’s
tailored research recovery roadmap that combines central oversight and governance with local decision making and site centricity to address the
complexity of the pandemic’s impact on research globally. The roadmap supports adaptive, agile and innovative approaches to maintain continuity,
protect patients and preserve critical endpoints. In the longer term, Covance’s comprehensive approach to research recovery is designed to support
patients, minimize the number of patients that drop out of studies, prevent missed visits to sites and optimize data integrity.
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LabCorp (USA) Launches New Neutralizing Antibody Test
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35
Solution Description
LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, announced the launch of a new test that can be
used to assess the capacity of antibodies in patient plasma to inhibit the SARS-CoV-2 virus. This information could be used in the development of
COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use. This neutralizing antibody test will be
available to biopharmaceutical companies, hospitals, blood banks and other plasma-screening facilities. As the research for a safe and effective
vaccine continues, some clinicians are relying on the serum collected from convalescent patients who had COVID-19 to support treatment of the
severely ill. As research advances, the PhenoSense® assay may be an essential element in defining the neutralizing antibody activity correlated
with the therapeutic efficacy of convalescent plasma administration, as well as the relative protective immunity of vaccine candidates. LabCorp,
an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical
laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class
diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported
revenue of more than $11.5 billion in 2019.
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XPOVIO, FDAApproved for Treatment of Relapsed or Refractory Diffuse Large
B-cell Lymphoma, Available at Biologics by McKesson (USA)
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36
Solution Description
Biologics by McKesson, an independent specialty pharmacy specializing in oncology, rare diseases and other complex therapeutic areas, was
selected by Karyopharm Therapeutics, Inc. as a specialty pharmacy provider for XPOVIO® for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of
systemic therapy. This indication was approved based on response rate under the U.S. Food and Drug Administration’s Accelerated Approval
Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. XPOVIO was
approved by the FDA for this second cancer indication and is the company’s first-in-class, Selective Inhibitor of Nuclear Export compound. This
treatment has been granted both Fast Track and Orphan Drug designations from the FDA. XPOVIO was previously approved as the first and only
nuclear export inhibitor that blocks Exportin 1 and is indicated in combination with dexamethasone for the treatment of adult patients with relapsed
or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors,
at least two immunomodulatory agent, and an anti-CD38 monoclonal antibody.
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Merck (USA): LYNPARZA® Approved in the EU for Germline BRCA-mutated Metastatic
Pancreatic Cancer
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37
Solution Description
AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that LYNPARZA has been approved in the European
Union as a monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma
of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. The
approval by the European Commission was based on results from the Phase 3 POLO trial, which were published in The New England Journal of
Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines
Agency. Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate of the most common cancers. Approximately 5-7% of
patients with metastatic pancreatic cancer have a germline BRCA mutation. LYNPARZA is approved in the U.S. and several other countries as a
first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of
a first-line platinum-based chemotherapy regimen, based on the Phase 3 POLO trial, with ongoing regulatory reviews in other jurisdictions.
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FDAApproves Merck’s (USA) KEYTRUDA® for First-Line Treatment of Patients with
Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
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38
Solution Description
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved KEYTRUDA,
Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high or
mismatch repair deficient colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA
significantly reduced the risk of disease progression or death by 40% compared with chemotherapy, the current standard of care. In the study,
treatment with KEYTRUDA also more than doubled median progression-free survival compared with chemotherapy versus 8.2 months.
Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis,
endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic
hematopoietic stem cell transplantation. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and
corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its
mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important
Safety Information” below.
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FDAApproves Merck’s KEYTRUDA®(USA) for the Treatment of Patients with Recurrent or Metastatic
Cutaneous Squamous Cell Carcinoma that is Not Curable by Surgery or Radiation
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39
Solution Description
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved KEYTRUDA,
Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is
not curable by surgery or radiation. This approval is based on data from the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated
meaningful efficacy and durability of response, with an objective response rate of 34%, including a complete response rate of 4% and a partial
response rate of 31%. Among responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5
months, the median duration of response had not been reached. Immune-mediated adverse reactions, which may be severe or fatal, can occur with
KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ
transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Based on the severity of the adverse reaction,
KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or
life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant
woman. For more information, see “Selected Important Safety Information” below.
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FDAApproves Merck’s GARDASIL 9 (USA)for the Prevention of Certain HPV-Related Head and Neck
Cancers
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40
Solution Description
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved an expanded
indication for GARDASIL9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and
58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing
HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in
a confirmatory trial. The trial is currently underway. Both men and women can be at risk for HPV-attributable oropharyngeal cancer; however, this
cancer affects men five times more than women.1 For most people, HPV clears on its own. But, for those who don't clear the virus, it can cause
certain cancers. Oropharyngeal cancer can arise as a result of HPV infection in the oropharynx, which includes the soft palate, side and back wall
of the throat, tonsils, and back one-third of the tongue. According to a recent model published by the U.S. Centers for Disease Control and
Prevention, HPV-attributable oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the U.S.
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Novozymes (Denmark): New biological solution brings the natural umami flavor from
plant proteins
For any queries, Please write to marketing@itshades.com
41
Solution Description
Novozymes has launched two new enzymes that enable food manufacturers to produce tasty, label-friendly meat alternatives with
less salt. More and more consumers demand low-salt, savory products with excellent taste and based on natural and recognizable
ingredients. At the same time, the rapidly growing market1 for plant-based meat analogues calls for vegetarian ways to create the
umami taste of meat. To round off and enhance the umami taste of savory products such as meat analogues, soups, sauces and
snacks while enabling salt reduction, food producers have the options to use yeast extract or hydrolysed vegetable proteins. Yeast
extract is a natural source of umami. But some consumers tend to shy away from products labelled with this ingredient as it is not
perceived kitchen-cupboard-like, just as some may perceive an off-taste. Traditional HVP is free from any off-taste from yeast
but is produced by means of chemicals and high energy consumption; processes which are often incompatible with natural claims
and consumer preferences.
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Pfizer (USA): FDAApproves Bavencio As First-Line Maintenance Treatment for Patients
with Locally Advanced or Metastatic Urothelial Carcinoma
For any queries, Please write to marketing@itshades.com
42
Solution Description
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc.
announced that the US Food and Drug Administration has approved the supplemental Biologics License Application for
BAVENCIO® for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not
progressed with first-line platinum-containing chemotherapy. The approval is based on results from the Phase III JAVELIN
Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival with BAVENCIO as
first-line maintenance plus best supportive care compared with BSC alone: 21.4 months vs. 14.3 months. This statistically
significant improvement in OS represents a 31% reduction in the risk of death in the overall population. OS was measured from
the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a
period of approximately four months. The JAVELIN Bladder 100 results were presented at the ASCO 2020 Virtual Scientific
Meeting. Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease
based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of
initiation of treatment, and only 5% of patients with metastatic disease at diagnosis will live longer than five years.
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Pfizer (USA): European Commission Approves Daurismo™ For Certain Adult Patients
with Newly Diagnosed Acute Myeloid Leukemia
For any queries, Please write to marketing@itshades.com
43
Solution Description
Pfizer Inc. announced that the European Commission approved DAURISMO™, a Hedgehog pathway inhibitor, in combination
with low-dose cytarabine, a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia in adult patients
who are not candidates for standard chemotherapy. The approval follows the medicine’s positive opinion from the Committee for
Medicinal Products for Human Use of the European Medicines Agency earlier this year, as well as the medicine’s approval by the
U.S. Food and Drug Administration in November 2018. The European Commission’s approval of DAURISMO is based on
results from the Phase 2 BRIGHT 1003 trial, which showed DAURISMO nearly doubled median overall survival compared to
LDAC alone in patients with previously untreated AML who were not eligible for intensive chemotherapy. The difference
represented a 54 percent reduction in the risk of death for patients treated with DAURISMO plus LDAC.
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FDA approves Roche’s Phesgo (Switzerland) for HER2-positive breast cancer
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44
Solution Description
Roche announced that the US Food and Drug Administration has approved Phesgo™, a fixed-dose combination of Perjeta® and
Herceptin® with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the
treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies
that can be administered by a single SC injection. Phesgo is available in one single-dose vial. Administration can take approximately eight
minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to
approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and
between 60-150 minutes for subsequent maintenance infusions of the two medicines. Phesgo can be administered by a healthcare
professional in a treatment centre or at a patient’s home. The approval is based on results from the pivotal phase III FeDeriCa study, which
met its primary endpoint with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval, when compared
to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus
Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most
common adverse events in both arms were alopecia, nausea, diarrhoea and anaemia.
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Roche’s ENSPRYNG® (Switzerland) approved in Japan for adults and children with
neuromyelitis optica spectrum disorder
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45
Solution Description
Roche announced that Japan’s Ministry of Health, Labour and Welfare has approved ENSPRYNG® for the prevention of relapses of neuromyelitis
optica spectrum disorder, including NMO, for aquaporin-4 antibody seropositive adults and children. ENSPRYNG demonstrated robust efficacy
and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as
an add-on therapy to baseline immunosuppressant therapy, and is dosed subcutaneously every four weeks. NMOSD is commonly associated with
pathogenic antibodies that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve, spinal cord
and brain. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of NMOSD patients, and these patients tend to experience a
more severe disease course. Although most cases of NMOSD can be confirmed through a diagnostic test, up to 30% of people living with the
condition are still frequently misdiagnosed with multiple sclerosis. ENSPRYNG is a humanised monoclonal antibody that targets the IL-6 receptor,
believed to play a key role in the inflammation that occurs in people with NMOSD. ENSPRYNG was designed by Chugai Pharmaceutical Co., a
member of the Roche group, using novel antibody recycling technology. Compared to conventional technology, this allows for longer duration of
antibody circulation and maximum inhibition of IL-6 signalling, while minimising safety risks in a chronic disease setting. People with NMOSD
experience unpredictable, severe relapses directly causing cumulative, irreversible neurological damage and disability. Preventing relapses
through early treatment can have a positive impact on preventing disability and is the primary goal for NMOSD disease management.
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Roche (Switzerland) improves speed and accuracy of non-small cell lung cancer diagnosis
with launch of automated digital pathology algorithm
For any queries, Please write to marketing@itshades.com
46
Solution Description
Roche announced the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 image analysis for non-small cell
lung cancer. The algorithm provides pathologists with automated assessments of scanned slide images that are objective and reproducible
and have the potential to aid diagnosis and, ultimately, targeted treatment options for patients. Validated on the VENTANA PD-L1 Assay,
the algorithm is ready-to-use and integrated within the Roche uPath enterprise software, a universal digital platform for case management,
collaboration and reporting. This algorithm will help pathologists to quickly determine whether tumours are positive for the PD-L1
biomarker, highlighting positively and negatively stained tumour cells with a clear visual overlay for easy reference. Patients with
tumours that are positive for the PD-L1 biomarker may be eligible for targeted treatment. The algorithm’s whole-slide automated analysis
uses artificial intelligence to provide, with one-click, an actionable assessment of the scanned slide images that is objective and
reproducible. The uPath PD-L1 image analysis algorithm for digital pathology is for use on uPath enterprise software.
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Thermo Fisher Scientific (USA) Launches New MAS Omni Infectious Disease Quality
Controls
For any queries, Please write to marketing@itshades.com
47
Solution Description
Thermo Fisher Scientific, the world leader in serving science, announced the availability of the Thermo Scientific MAS Omni Infectious
Disease quality control sets for monitoring serological assays for analytes such as HIV 1&2, Hepatitis B & C virus, Syphilis and HTLV
I/II. Serology testing for infectious diseases continues to be on the rise and newer instrument platforms are offering serology markers with
improved sensitivity than previously available. In addition, there is continued progression with infectious disease screening protocols
requiring serology testing for diagnosis, monitoring and treatment of infectious agents. The Thermo Scientific MAS Omni Infectious
positive and negative quality controls are third-party, independent external controls used to assess the performance of serological assays
for infectious diseases. Our new control set supports assays for HIV, Hepatitis C, Hepatitis B, HTLV and Syphilis. As with all Thermo
Scientific MAS Quality Controls users can efficiently monitor assay performance, streamline operations and potentially reduce your
spending without sacrificing quality or throughput.
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iSPA (USA) Workflow Helps Pharmaceutical Companies Bring New Drugs to Market
Faster
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48
Solution Description
Thermo Fisher Scientific has released the Thermo Scientific iSPA Workflow, the first commercially available single particle analysis
workflow solution. As pharmaceutical labs turn to cryo-electron microscopy to uncover the structures of difficult-to-crystalize molecules
at near atomic resolution, they need ways to increase their productivity to more quickly move from early drug discovery to clinical trials.
iSPA Workflow solves this problem by providing an easy-to-use, highly productive and automation-enhanced solution to match the pace
of drug discovery. Developed with input from users in the pharmaceutical industry, this SPA dedicated workflow is designed for structural
biologists of all experience levels who need to deliver structural insights. With reduced manual steps, the workflow is simplified and
preparing the microscope for data collection takes less than 30 minutes. Companies can also increase productivity by using its unattended
data collection feature, which allows them to collect data from multiple grids while not at the instrument. The solution offers uptime
reliability of instruments, helping users avoid time spent troubleshooting equipment problems. The flagship of the iSPA workflow is the
Thermo Scientific Krios Rx, a high-end cryo-transmission electron microscope designed specifically for ease-of-use and enhanced
automation. Automation facilitates unattended data collection, and requires minimal expertise to operate the microscope, freeing up time
to focus on results.
IT Shades
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For any queries, Please write to marketing@itshades.com
Rewards & Recognition
Updates Healthcare Industry
R & R Updates
IT Shades
Engage & Enable
CVS Health (USA) named ‘Presenting and Official Health and Wellness
Sponsor’ for the Washington Spirit professional soccer team
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49
The Washington Spirit is proud to announce CVS Health as their new presenting and official health and wellness sponsor for the 2020
season. The sponsorship reflects a shared goal of building healthier communities, with a focus on the health and wellness of women
and underserved youth. CVS Health will be the presenting sponsor for all team youth community initiatives, which encompass
discussions of healthy lifestyle as well as nutrition, mental resiliency, skills challenges and other activities. The CVS Health brand will
be featured on the front of the team jersey, around the club and during designated Spirit home games during the 2020 NWSL Challenge
Cup. In addition, CVS Pharmacy ExtraCare® card holders will be eligible for discounts in the team store. CVS Health is one of many
businesses to join the Washington Spirit family in the 2019–2020 offseason. This growing group of sponsors, in collaboration with the
Spirit, will help continue to grow the game of women’s soccer in the Washington, D.C. metro area. CVS Health employees are united
around a common goal of becoming the most consumer-centric health company in the world. They're evolving based on changing
consumer needs and meeting people where they are, whether that's in the community at one of their nearly 10,000 local touchpoints, in
the home, or in the palm of their hand.
R&R Description
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CVS Health (USA) recognized as one of the ‘50 most community-minded
companies’ by Points of Light
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50
CVS Health has been named a 2020 honoree of The Civic 50 by Points of Light, one of the world’s largest organizations dedicated to
volunteer service. This marks the fourth consecutive year that CVS Health has been named to The Civic 50. The award recognizes CVS
Health as one of the 50 most community-minded companies in the United States. The Civic 50 provides a national standard for superior
corporate citizenship and showcases how companies can use their time, skills and resources to impact their communities. The Civic 50
honorees are public and private companies with U.S. operations and revenues of $1 billion or more, and are selected based on four
dimensions of their U.S. community engagement program, including investment, integration, institutionalization and impact. In 2019,
CVS Health employees donated more than $12 million worth of volunteer time. From team service projects to serving on boards as
mentors and company hosted volunteer activities, employees participated in thousands of volunteer events representing CVS Health in
their local communities.
R&R Description
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Customer Success
Healthcare Industry
Customer Success Updates
IT Shades
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AstraZeneca (UK) to supply Europe with up to 400 million doses of
Oxford University’s vaccine at no profit
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51
AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy and the
Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of
2020. With agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that
wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe.
AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The Company is seeking
to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support
access to the vaccine at no profit during the pandemic. The Company has recently completed similar agreements with the UK, US, the
Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance for 700 million doses, and it agreed a licence with the
Serum Institute of India for the supply of an additional one billion doses, principally for low- and middle-income countries. Total
manufacturing capacity currently stands at two billion doses.
Description
Customer Success Updates
IT Shades
Engage & Enable
Cigna (USA), Huntsville Hospital Health System Reach Agreement to Provide Value-Based
Care to Medicare Advantage Customers in Northern Alabama
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52
Cigna and Huntsville Hospital Health System have reached an agreement under which the organizations will collaborate to provide
value-based care to customers of Cigna Medicare Advantage plans. Value-based care places quality above quantity with a particular
focus on proactive, coordinated care that prioritizes wellness and disease prevention. Huntsville Hospital has operated as a
community-owned hospital since 1895. Today, the hospital is the second largest facility in the state and the centerpiece of a
multi-hospital Health System across north Alabama, serving as the regional referral and trauma center for more than a million residents
of the Tennessee Valley. Huntsville Hospital Health System operates hospitals in Huntsville, Madison, Athens, Decatur,
Boaz-Albertville, Guntersville-Arab, Sheffield and Red Bay. The Health System includes more than 2,000 licensed beds for patient care
and employs more than 15,000 persons. Cigna Corporation is a global health service company dedicated to improving the health,
well-being and peace of mind of those we serve. Cigna delivers choice, predictability, affordability and access to quality care through
integrated capabilities and connected, personalized solutions that advance whole person health.
Description
Customer Success Updates
IT Shades
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Regeneron (USA) Announces Manufacturing and Supply Agreement for Barda And U.S.
Department of Defense for Regn-Cov2 Anti-Viral Antibody Cocktail
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53
Regeneron Pharmaceuticals, Inc. announced that, as part of Operation Warp Speed, the Biomedical Advanced Research and
Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health
and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2. REGN-COV2 is
Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19
and in a Phase 3 trial for the prevention of COVID-19 infection. Regeneron began scaling up manufacturing of REGN-COV2 at
business risk in spring of 2020. This agreement supports continued manufacturing so that the product could be made available
immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration grants Emergency Use
Authorization or product approval. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of
2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will
help establish the exact number of potential treatment doses or prevention doses available from these lots in total. Initial doses may be
ready as early as end of summer. If EUA or product approval is granted, the government has committed to making doses from these
lots available to the American people at no cost and would be responsible for their distribution.
Description
Customer Success Updates
IT Shades
Engage & Enable
Vertex (USA) Announces Expansion of Reimbursement Agreement with NHS England to
Include KAFTRIO® in Combination With KALYDECO®
For any queries, Please write to marketing@itshades.com
54
Regeneron Pharmaceuticals, Inc. announced that, as part of Operation Warp Speed, the Biomedical Advanced Research and
Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health
and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2. REGN-COV2 is
Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19
and in a Phase 3 trial for the prevention of COVID-19 infection. Regeneron began scaling up manufacturing of REGN-COV2 at
business risk in spring of 2020. This agreement supports continued manufacturing so that the product could be made available
immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration grants Emergency Use
Authorization or product approval. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of
2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will
help establish the exact number of potential treatment doses or prevention doses available from these lots in total. Initial doses may be
ready as early as end of summer. If EUA or product approval is granted, the government has committed to making doses from these
lots available to the American people at no cost and would be responsible for their distribution.
Description
Customer Success Updates
IT Shades
Engage & Enable
Vertex (USA) Announces Expansion of Reimbursement Agreement with NHS England to
Include KAFTRIO® in Combination With KALYDECO®
For any queries, Please write to marketing@itshades.com
55
Vertex Pharmaceuticals Incorporated announced that it has expanded its reimbursement agreement with NHS England for
Vertex’s cystic fibrosis medicines to include KAFTRIO®, in a combination regimen with KALYDECO® 150 mg, ahead of
the medicine’s anticipated approval by the European Commission. The new expanded agreement includes reimbursed
access to Vertex’s currently licensed medicines — KALYDECO®, ORKAMBI® and SYMKEVI®, as well as the triple
combination therapy if approved — and any future additional licensed indications for all of these medicines. The European
Medicines Agency’s Committee for Medicinal Products for Human Use recently adopted a positive opinion for
KAFTRIO® in a combination regimen with KALYDECO® 150 mg to treat people with cystic fibrosis ages 12 and older
with one F508del mutation and one minimal function mutation or two F508del mutations in the cystic fibrosis
transmembrane conductance regulator gene.
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I-Bytes Healthcare Industry

  • 1. IT Shades Engage & Enable I-Bytes Healthcare July Edition 2020 Email us - solutions@itshades.com Website : www.itshades.com
  • 2. IT Shades Engage & Enable For any queries, Please write to marketing@itshades.com About Us Who We are Aim of this IByte Reasons to talk to us ITShades.com has been founded with singular aim of engaging and enabling the best and brightest of businesses, professionals and students with opportunities, learnings, best practices, collaboration and innovation from IT industry. This document brings together a set of latest data points and publicly available information relevant for Healthcare Industry. We are very excited to share this content and believe that readers will benefit from this periodic publication immensely. 1. Publishing of your company’s solutions/ announcements in this document. 2. Subscribe to this and other periodic publications i.e. I-Bytes, Solution Letters from ITShades.com. 3. For placement of your company's click-able logo and advertisements. 4. Feedback for us to improve the content and format of these periodic publications.
  • 3. IT Shades Engage & Enable Feel free to contact us at marketing@itshades.com for any queries Sponsoring Companies for this Edition LOGO 1 LOGO 2 LOGO 3 LOGO 4 LOGO 5
  • 4. IT Shades Engage & Enable For any queries, Please write to marketing@itshades.com Table of Contents 1. Financial, M & A Updates...................................................................................................................................1 2. Solution Updates................................................................................................................................................14 3. Rewards and Recognition Updates..................................................................................................................49 4. Customer Services.............................................................................................................................................51 5. Partnership Ecosystem Updates......................................................................................................................56 6. Miscellaneous Updates.....................................................................................................................................80
  • 5. IT Shades Engage & Enable For any queries, Please write to marketing@itshades.com Financial, M & A Updates Healthcare Industry
  • 6. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Alexion (USA) Completes Acquisition of Portola Alexion Pharmaceuticals, Inc. announced the successful completion of its acquisition of Portola Pharmaceuticals, Inc. The acquisition adds Factor Xa inhibitor reversal agent Andexxa®, marketed as Ondexxya® in Europe, to Alexion’s commercial portfolio. Andexxa is the first and only approved Factor Xa inhibitor reversal agent and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding. Alexion completed the acquisition through a tender offer and subsequent merger of Portola with Odyssey Merger Sub Inc., a wholly owned subsidiary of Alexion. Portola is now a wholly owned subsidiary of Alexion. The tender offer for all of the outstanding shares of common stock of Portola at a price of $18.00 per share expired as scheduled, one minute following 11:59 p.m., New York City time. American Stock Transfer & Trust Company, LLC, the depositary and paying agent for the tender offer, has advised Alexion that 62,654,962 shares of Portola common stock were validly tendered and not validly withdrawn in the tender offer, representing approximately 79.7% of the shares outstanding. Executive Commentary “This acquisition provides the opportunity to grow our commercial portfolio, which builds on the significant progress we’ve made diversifying our pipeline over the last few years, said Chief Executive Officer of Alexion. We are excited to add a transformative, first-in-class medicine like Andexxa, which rapidly reverses life-threatening bleeds that result from Factor Xa inhibitors, to our growing critical care portfolio. This important medicine is also a clear strategic fit with our existing expertise in hematology and neurology, and we are confident we can apply our demonstrated global commercial excellence to enhance access and broaden the number of patients helped by Andexxa.” For any queries, Please write to marketing@itshades.com Description 1
  • 7. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Centene's Illinois Subsidiary (USA) to Acquire Membership of NextLevel Health Partners Centene Corporation announced that its Illinois subsidiary, Meridian Health Plan of Illinois, Inc., and NextLevel Health Partners, Inc., a health plan serving Medicaid member in Cook County, Illinois, have entered into a Member Transfer Agreement. Under the agreement, Meridian will be assigned 100% of NLHP's approximately 54,000 members who access benefits from the Illinois Department of Healthcare and Family Services' HealthChoice Illinois Program. As part of the agreement, Meridian has executed a care coordination agreement with NLHP to ensure continuity of care for a subset of the assigned membership, effective concurrently with the closing of the transaction. Centene provided the initial capital NLHP needed to obtain its HMO licensure at the end of 2017, enabling a minority-owned and -operated health plan to participate in the Illinois Medicaid program. Since then, Centene has continued to provide operational support to NLHP. Centene Corporation, a Fortune 50 company, is a leading multi-national healthcare enterprise that is committed to helping people live healthier lives. The Company takes a local approach – with local brands and local teams to provide fully integrated, high-quality, and cost-effective services to government-sponsored and commercial healthcare programs, focusing on under-insured and uninsured individuals. Executive Commentary "We are pleased to continue to support NextLevel Health Partners by entering into a care coordination agreement, while expanding our presence in Cook County and working with our members, providers and government partners to achieve better health outcomes at lower costs for the state of Illinois, said President and CEO of Centene. We look forward to leveraging our scale and continuing to grow our relationships with these valued partners." For any queries, Please write to marketing@itshades.com Description 2
  • 8. Lore Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Community Health Systems (USA) Announces Definitive Agreement to Sell St. Petersburg, Florida Hospital Community Health Systems, Inc. announced that an affiliate of the Company has signed a definitive agreement to sell 480-bed Bayfront Health St. Petersburg in St. Petersburg, Florida, and its associated assets to a subsidiary of Orlando Health. Orlando Health will assume responsibility for the long-term lease and operations of the hospital. The lease transfer is subject to the consent of the St. Petersburg City Council. The transaction is expected to close by the end of the third quarter this year, subject to regulatory approvals and closing conditions. The hospital in this transaction is among the additional potential divestitures discussed on the Company’s first quarter 2020 earnings call. Community Health Systems, Inc. is one of the largest publicly traded hospital companies in the United States and a leading operator of general acute care hospitals in communities across the country. The Company, through its subsidiary, owns, leases or operates 99 affiliated hospitals in 17 states with an aggregate of approximately 16,000 licensed beds. The Company’s headquarters are located in Franklin, Tennessee, a suburb south of Nashville. For any queries, Please write to marketing@itshades.com Description 3
  • 9. Lore Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable DSM (Netherland) issues €1 billion long-term bonds to finance acquisition of Erber Group Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces the successful launch of €1 billion bonds, in two tranches: a €500m bond with an eight-year maturity due in 2028, at a coupon of 0.25%, and a €500m bond with a twelve-year maturity due in 2032, at a coupon of 0.625%. The new bond issues take advantage of favorable market conditions and allow the company to lock in low interest rates to finance the recently announced acquisition of Erber Group. The terms are laid down in the €5 billion Debt Issuance Program of Royal DSM, the final terms and the supplements thereto being available here. The re-offer price for the eight-year bond tranche was 99.653%. Based on this price the yield is 0.294%. The re-offer price for the twelve-year bond tranche was 99.128%. Based on this price the yield is 0.701%. The bonds will shortly be listed on Euronext Amsterdam. This release does not constitute an offer or an invitation to subscribe for or purchase any securities. The notes are being offered only by means of a prospectus. For any queries, Please write to marketing@itshades.com Description 4
  • 10. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Illumina (USA) Acquires BlueBee to Accelerate Processing, Analysis and Sharing of Next Generation Sequencing Data at Scale Illumina, Inc. is enhancing its capabilities to analyze and interpret the data produced by its sequencing systems with the acquisition of BlueBee, a cloud-based software company that provides genomics analysis solutions for research and clinical customers. Based in the Netherlands, BlueBee has developed a regulatory compliant, secure cloud platform that simplifies access to data and tools, enabling users to easily extract insights from genomic data. This cloud capability is expected to lower the cost of storing, sharing and managing the enormous volumes of genomic data that streams from Illumina’s installed base of more than 15,000 sequencing systems. he integration of BlueBee’s capabilities into Illumina’s cloud portfolio will give users the flexibility to run their own custom analyses or access industry leading options such as the DRAGEN ™ Bio-IT Platform, streamlining data processing and increasing their operational efficiency. Users also will be able to aggregate, explore and collaborate on data and methods directly in the cloud through a user-friendly, ISO-compliant, flexible interface. BlueBee’s capabilities include intuitive analysis management, multi-modal data management, and data science and AI tools, as well as integrated business analytics, and multi-cloud or on-premise deployment modes. This is a substantial addition to Illumina’s cloud software portfolio which includes BaseSpace™ Sequencing Hub, one of the most widely utilized software for sequencing run management and data sharing. Executive Commentary “We are thrilled to welcome the BlueBee team to Illumina, and excited by the promise of delivering a streamlined way for users to analyze, explore and securely manage large scale genomics data, said Senior Vice President of Product Development at Illumina. Combining BlueBee and Illumina software products provides the most scalable, efficient and extensible genomic analysis solutions for both clinical and translational research use cases. BlueBee truly brings unique capabilities, while ensuring secure deployment of clinical informatics across the globe, and together we hope to deliver an unprecedented learning environment in order to unlock the full potential of genomic insights.” For any queries, Please write to marketing@itshades.com Description 5
  • 11. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Merck (USA) Animal Health Completes Acquisition of U.S. Rights to SENTINEL® Brand of Combination Parasiticides for Companion Animals Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA announced the completion of its previously announced acquisition of the U.S. rights to SENTINEL® FLAVOR TABS® and SENTINEL® SPECTRUM® Chews in the Companion Animal category from Virbac. Comprehensive parasite protection is an essential part of canine overall health and well-being. For more than a century, Merck, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, is the global animal health business unit of Merck. Through its commitment to TheScience of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Executive Commentary Comprehensive parasite protection is an essential part of canine overall health and well-being. Our veterinary medicines, including parasiticides, and vaccines continue to transform the animal health industry and further solidify our position in the U.S. Companion Animal category, said President, Merck Animal Health. The extensive breadth and depth of our product portfolio enhances our offerings of comprehensive pet care solutions, which provide a full range of complementary solutions for our customers to improve the health and well-being of animals and the people who care for them.” For any queries, Please write to marketing@itshades.com Description 6
  • 12. Lore Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Merck (USA) Completes Acquisition of Themis Merck, known as MSD outside the United States and Canada, announced the completion of the acquisition of Themis, a privately-held company focused on vaccines and immune-modulation therapies for infectious diseases and cancer. The U.S. Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and Merck has received merger control clearance from the Austrian Federal Competition Authority. Themis is now a wholly-owned subsidiary of Merck. An initial focus of this agreement is acceleration of the development of a measles vector-based SARS-CoV-2 vaccine candidate. This candidate is currently in pre-clinical development, and clinical studies are planned to start later in 2020. Themis developed a broad pipeline of vaccine candidates and immune-modulatory therapies using its innovative measles virus vector platform based on a vector originally developed by scientists at the Institut Pasteur, a world-leading European vaccine research institute, and licensed exclusively to Themis for select viral indications. In March, Themis joined a consortium together with the Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations, to develop a vaccine candidate targeting SARS-CoV-2 for the prevention of COVID-19. For any queries, Please write to marketing@itshades.com Description 7
  • 13. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Merck (USA) Animal Health Completes Acquisition of Quantified Ag® Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA announced the completion of its acquisition of Quantified Ag®, a leading data and analytics company that monitors cattle body temperature and movement in order to detect illness early. In April 2018, Merck Animal Health invested in Quantified Ag® and partially funded their development work in data analytics in livestock. Specific terms of the agreement were not disclosed. The announcement further positions Merck Animal Health as a global leader in animal health, broadening its portfolio in connected technology to improve cattle health outcomes by leveraging data and analytics for animal health and well-being. Quantified Ag®, located in Lincoln, Nebraska, provides a pro-active system for cattle producers and feedlot operators to track an animal’s biometrics and behavioral data through a non-invasive cattle ear tag equipped with sensors to monitor the health of the individual animal or herd. The technology can detect animal illness, thus reducing the potential for disease outbreak, allowing for easy identification of sick animals, and providing easy-to-use software reports on any mobile device, desktop, tablet or secure website. Proprietary algorithms are able to identify animals showing signs of illness or disease and provide real-time alerts. Executive Commentary “We are pleased to take this step forward with Quantified Ag® as we continue to broaden our portfolio with complementary products and technologies to advance animal well-being for our customers, said President, Merck Animal Health. Our goal is to improve the detection of animal illness, and the responsible use of treatments to maintain the health of livestock. We are at the technological forefront of shaping the future of animal health through our commitment to leveraging our scientific and technical capabilities and expertise through comprehensive solutions to manage the health and well-being of animals.” For any queries, Please write to marketing@itshades.com Description 8
  • 14. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Novozymes (Denmark) acquires PrecisionBiotics Group to advance its business within human health Novozymes announced that it has acquired PrecisionBiotics Group Limited. Based in Cork, Ireland, PrecisionBiotics Group holds a leading position within probiotics for human gut health and is well positioned with several clinically backed products already in the market. PrecisionBiotics Group has strong expertise within clinical development, upscaling and commercialization and is well situated in Cork, Ireland, home to a leading academic society within human gut health. Novozymes has established OneHealth to market solutions within human health under one umbrella. The aim is to help people live healthier and better lives by use of probiotics and enzymes. Novozymes has acquired 100% of the equity in PrecisionBiotics Group Limited for an amount of DKK 600 million on a cash and debt-free basis. The transaction is structured with an earn-out model, is financed with cash and bank facilities, and does not change the capital structure policy of Novozymes. The acquisition gives Novozymes broader access to the overall consumer health market and more specifically a stronger entry point into the DKK 40 billion human probiotic supplements market which is expected to grow with a high-single-digit CAGR over the next 3-5 years. Executive Commentary “This acquisition fits well with our strategy, Better business with biology, where we have focus on human health as one of our opportunities for growth. With this investment, we take another important step in implementing the strategy and setting a foundation of growth for our business,” says President and CEO of Novozymes. For any queries, Please write to marketing@itshades.com Description 9
  • 15. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Quest Diagnostics (USA) to Expand in Indiana with Acquisition of Outreach Lab Businesses of Community Health Network and Ascension St. Vincent Now Serviced Through Mid America Clinical Laboratories Quest Diagnostics, the world's leading provider of diagnostic information services, announced the formation of a definitive multi-pronged agreement designed to optimize the delivery of high quality, innovative diagnostic laboratory services in Indiana. Through this all-cash equity transaction, Quest will acquire its joint venture partners' interests in Mid America Clinical Laboratories and operate the business by itself. Formed about 20 years ago as a joint venture company by Quest Diagnostics, Ascension St. Vincent and Community Health Network, MACL is now the largest independent clinical laboratory provider in Indiana. Upon closing, Quest will wholly own MACL's laboratory in Indianapolis and approximately 50 patient service centers across Indiana. As part of the transaction, Quest will also provide professional hospital lab services under long-term service agreements for approximately 30 hospital labs owned and operated by Ascension St. Vincent and Community Health Network. AmeriPath Indiana will continue to provide specialized pathology services to CHN and Ascension St. Vincent as well as to the broader community in Indiana, Assuming the transaction's completion, providers and patients will benefit from direct access to Quest's broader, high quality and innovative test services in Indiana. Executive Commentary "This transaction delivers on our accelerate growth and operational excellence strategies, which focus on strategically aligned, accretive acquisitions, while bolstering our professional lab services, said Quest Diagnostics Chairman, CEO and President. Health systems increasingly turn to Quest Diagnostics to optimize their lab strategies. We are pleased to take this step forward to deliver actionable diagnostic insights to more patients and providers in Indiana." For any queries, Please write to marketing@itshades.com Description 10
  • 16. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Sanofi (France) invests to make France its world class center of excellence in vaccine research and production Sanofi detailed plans on how the Company will make significant investments in France to increase its vaccines research and production capacities, and contribute in responding to future pandemic risks. Aligned with its corporate strategy presented last December, Sanofi will invest €610 million to create a new production site and research center in France with both dedicated to vaccines. Sanofi will invest in vaccine production in France and create its Evolutive Vaccine Facility in Neuville sur Saône. This state-of-the-art industrial site will utilize the latest innovative vaccine production technologies. The project represents an investment of €490 million over a five-year period, and is expected to create 200 new jobs. Sanofi’s investment has been made possible thanks to the support and the close collaboration with French authorities over the last few months. The building of this plant will enable Sanofi Pasteur, Sanofi's global entity dedicated to vaccines, to be the first pharmaceutical manufacturer to benefit from such an industrial tool and to secure vaccine supplies in the event of new pandemics. EVF is a new type of factory designed around a central unit housing several fully digital production modules that make it possible to produce three to four vaccines simultaneously, versus only one in current industrial sites. This modularity will make it possible to prioritize the production of a specific vaccine in a more timely manner based on public health issues. Executive Commentary “Sanofi’s heart beats in France. We have a long history and exceptional teams working throughout the country, embodying our strong values. By investing in a new industrial site and a R&D center, Sanofi positions France at the core of its strategy, aiming to make France a world-class center of excellence in vaccine research and production, said Chief Executive Officer at Sanofi. Sanofi is a major healthcare player in France, in Europe, and worldwide. It is our responsibility to focus our resources and expertise against the current pandemic, but also to invest in preparing for future ones. We welcome the ongoing collaboration and commitment of the French authorities who we have been working alongside with the last several months to achieve this.” For any queries, Please write to marketing@itshades.com Description 11
  • 17. Financial, M&A Updates IT Shades Engage & Enable Walgreens Boots Alliance (USA) Reports Fiscal 2020 Third Quarter Results Highlights • Sales increased 0.1 percent to $34.6 billion, up 1.2 percent on a constant currency basis, led by Retail Pharmacy USA comparable sales growth of 3.0 percent • Operating loss of $1.6 billion, compared to operating income of $1.2 billion a year ago, mainly due to the non-cash impairment charges of $2 billion in Boots UK; Adjusted operating income decreased 46.5 percent to $919 million on a reported basis, down 46.4 percent on a constant currency basis • Loss per share was $1.95, compared to EPS of $1.13 a year ago; Adjusted EPS decreased 43.8 percent from $1.47 to $0.83, down 43.4 percent on a constant currency basis; Results reflect $0.61 to $0.65 per share estimated operational impact from COVID-19 Adverse sales impact of approximately $700 million to $750 million, almost entirely from the company's non-U.S. businesses • Gross margin adversely impacted by shift from higher to lower margin categories, supply chain costs • SG&A increased due to higher employee costs and social distancing and cleaning expenses • Both operating income and adjusted operating income included an adverse impact of $700 million to $750 million from the above items, or $0.61 to $0.65 per share, excluding impairment charges • Most significant COVID-19 impact was in UK market, requiring a review resulting in non-cash impairment charges of $2 billion • Company took actions to partly mitigate COVID-19 impacts Executive Commentary Executive Vice Chairman and CEO said, “Prior to the pandemic our financial performance for fiscal 2020 was on track with our expectations. However, this unprecedented global crisis led to a loss in the quarter as stay-at-home orders affected all of our markets. I'm very proud of how all of our teams mobilized and adapted to deliver essential services in our communities across the world. Shopping patterns are evolving more rapidly than ever as consumers further embrace digital options, spurring us to accelerate our ongoing investments in digital transformation and neighborhood health destinations. This includes our two recent announcements: a significant expansion of our primary care clinics collaboration with VillageMD, and our strategic partnership with Microsoft and Adobe to launch a personalized omnichannel healthcare and shopping experience.” For any queries, Please write to marketing@itshades.com 12 Key Financial Highlights
  • 18. Lorem ipsum dolor sit amet, consec- tetuer Financial, M&A Updates IT Shades Engage & Enable Zoetis (USA) Acquires Fish Vet Group to Enhance Aquaculture Diagnostic Capabilities Zoetis announced the acquisition of Fish Vet Group from Benchmark Holdings, PLC, as a strategic addition to its Pharmaq business which develops and commercializes fish vaccines and offers services in vaccination and diagnostics for aquaculture. Adding Fish Vet Group grows the geographic reach and enhances the diagnostics expertise and testing services, including environmental testing, that Pharmaq’s reference lab Pharmaq Analytiq now can offer fish farmers in major aquaculture markets. Fish Vet Group is headquartered in Inverness, Scotland, with diagnostic lab locations there as well as in Norway, Ireland and Chile, where it provides veterinary services and services in bacteriology, histology and PCR testing. To help fish producers comply with strict environmental standards, Fish Vet Group offers surveys and analysis to monitor potential environmental impact and inform responsible fish disease treatments as part of a sustainable aquaculture system. Tests and accompanying analyses from Fish Vet Group help producers to check the impact of existing fish farms and inform the potential for new site locations, determine and monitor seabed conditions, and provide input to required regulatory submissions. Comprehensive lab analysis includes marine and freshwater benthic taxonomy, sediment chemistry and water quality analysis. Executive Commentary “Raising healthy fish to meet the demands of our growing global population while respecting the environment is critical for a healthier, more sustainable future, said Executive Vice President and President of International Operations, for Zoetis. Innovative fish health management tools, across the continuum of care and including vaccines and diagnostic testing, will help us better meet the needs of our customers. We are excited to welcome Fish Vet Group to our aquaculture team at Pharmaq and together offer fish producers the most comprehensive suite of fish health solutions.” For any queries, Please write to marketing@itshades.com Description 13
  • 19. IT Shades Engage & Enable For any queries, Please write to marketing@itshades.com Solutions Updates Healthcare Industry
  • 20. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Allergan (USA): FDAApproves Expanded BOTOX® Label for the Treatment of Pediatric Patients with Spasticity For any queries, Please write to marketing@itshades.com 14 Solution Description Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration approved a supplemental Biologics License Application that supports expanded use of BOTOX® for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy. This label expansion is based on Allergan and another manufacturer selectively waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of pediatric patients with spasticity caused by cerebral palsy. BOTOX® was first approved in June 2019 for the treatment of pediatric patients with upper limb spasticity and in October 2019 for the treatment of pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy. BOTOX® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs. The severity can range from mild to severe, often interfering with normal muscular movement and function. This can result in delayed or impaired motor development, as well as difficulty with posture and positioning. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.
  • 21. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Allergan (USA), an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol For any queries, Please write to marketing@itshades.com 15 Solution Description Allergan, an AbbVie Company, and Molecular Partners, a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to the Biologics License Application for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular age-related macular degeneration. The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular age-related macular degeneration. AbbVie plans to meet with the FDA to discuss their comments and determine next steps. As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes over a dozen additional agents for multiple ocular conditions.
  • 22. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Allergan (USA): FDAAccepts Supplemental Biologics License Application for BOTOX® for the Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity For any queries, Please write to marketing@itshades.com 16 Solution Description Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration has accepted the company's supplemental biologics license application to expand the BOTOX® prescribing information for the treatment of signs and symptoms of detrusor overactivity associated with an underlying neurologic condition in pediatric patients who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication. The sBLA is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of BOTOX® in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study. The Prescription Drug User Fee Act date is expected to be in the first quarter of 2021 following a standard 10-month review. Neurogenic detrusor overactivity results from the inability of the spinal cord and bladder to communicate effectively. As a result, the bladder muscle involuntarily contracts, increasing the pressure in the bladder and reducing the bladder capacity, which can cause the individual to leak urine frequently and unexpectedly. If not adequately managed with clean intermittent catheterization and anticholinergic drugs, this condition may require augmentation cystoplasty to prevent renal damage.
  • 23. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Allergan (USA): FDAApproves JUVÉDERM® VOLUMA™ XC for Enhancement of the Chin Region For any queries, Please write to marketing@itshades.com 17 Solution Description Allergan Aesthetics, an AbbVie company, announced the FDA approval of JUVÉDERM® VOLUMA™ XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21.1 As the category leader, the JUVÉDERM® Collection of Fillers has the broadest portfolio of specifically tailored treatment options, and this latest approval marks their fifth approved indication in the U.S.1-5. JUVÉDERM® VOLUMA™ XC is the first and only filler to receive U.S. FDA approval for the augmentation of the chin region.1 This approval marks the second indication for the product, which was previously approved by the FDA in 2013 for cheek augmentation to correct age-related mid-face volume deficit. JUVÉDERM® VOLUMA™ XC is currently the number one product in the JUVÉDERM® portfolio in the U.S. and lasts up to two years with optimal treatment for cheek augmentation. At Allergan Aesthetics, an AbbVie company, they develop, manufacture, and market a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Their goal is to consistently provide their customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.
  • 24. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable CVS Pharmacy (USA) introduces new app feature for reading “talking” prescription labels For any queries, Please write to marketing@itshades.com 18 Solution Description CVS Pharmacy announced that it has developed Spoken Rx, a new feature of the CVS Pharmacy app that can read a specific type of label for patients with visual impairments and those who cannot read standard print labels. Spoken Rx is the first in-app prescription reader application to be developed by a national retail pharmacy. By the end of 2020, 1,500 CVS Pharmacy locations will be equipped to affix special RFID labels to prescription vials. When the RFID labels are scanned by Spoken Rx in the CVS Pharmacy app, which can be accessed by users using Siri or Google Assistant on their phones, prescription label information will be spoken out loud. This information, which is important for patient safety and adherence, currently includes patient name, medication name, dosage and directions and will be enhanced to include additional information over the months to come. Spoken Rx will be available in all CVS Pharmacy locations by the end of 2021. Enrollment in the program is seamless and can be done either over the phone or in store where a pharmacist can ensure the patient's app is appropriately set up for the service. Spoken Rx is free to CVS Pharmacy patients and the app will read prescription label information aloud in either English or Spanish.
  • 25. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Allergan (USA): ULTOMIRIS® Receives Marketing Authorization from European Commission for Adults and Children with Atypical Hemolytic Uremic Syndrome For any queries, Please write to marketing@itshades.com 19 Solution Description Alexion Pharmaceuticals, Inc. announced that the European Commission has approved ULTOMIRIS® the first and only long-acting C5 complement inhibitor administered every eight weeks for the treatment of adults and children with a body weight of 10 kg or above with atypical hemolytic uremic syndrome who are complement inhibitor treatment-naïve or have received SOLIRIS® for at least three months and have evidence of response to eculizumab. Atypical HUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. Atypical HUS affects both adults and children and many patients present in critical condition in the hospital setting, often requiring supportive care, including dialysis, in an intensive care unit. The prognosis of aHUS can be poor in many cases, with 56 percent of adults and 29 percent of children developing end-stage renal disease or dying within a year of diagnosis with supportive care alone,3 so a timely and accurate diagnosis – in addition to treatment – is critical to improving patient outcomes.
  • 26. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable BD (USA) Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing For any queries, Please write to marketing@itshades.com 20 Solution Description BD, a leading global medical technology company, announced that the U.S. Food and Drug Administration granted Emergency Use Authorization for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor™ Plus System. The launch of this new assay that delivers results in 15 minutes on an easy-to-use, highly portable instrument is critical for improving access to COVID-19 diagnostics because it enables real-time results and decision making while the patient is still onsite. The BD Veritor™ System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states. Its one-button functionality, workflow flexibility, and ease-of-use make it an ideal solution for settings without laboratory personnel. It also offers customers real-time reporting capabilities through the BD Synapsys™ informatics solution providing them with the ability to easily report data for disease monitoring and surveillance purposes. BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September.
  • 27. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Boston Scientific (USA) Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System For any queries, Please write to marketing@itshades.com 21 Solution Description Boston Scientific has received U.S. Food and Drug Administration 510(k) clearance for the LUX-Dx™ Insertable Cardiac Monitor System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke and syncope. The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Further, the remote programming capabilities of the device via the LATITUDE Clarity™ Data Management System website allow physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable on any other ICM currently on the market. The dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded. An additional level of verification filters is then applied, which was developed to catch false positive detections before an alert is sent. Additionally, after implant, patients are provided with a mobile device preloaded with the MyLUX™ app which connects via Bluetooth® to their ICM device. The app transmits device data daily, or as needed, to the LATITUDE Clarity Data Management System giving physicians and care teams timely access to vital information.
  • 28. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Bristol Myers Squibb (USA): European Commission Approves Reblozyl for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia For any queries, Please write to marketing@itshades.com 22 Solution Description Bristol Myers Squibb and Acceleron Pharma Inc. announced that the European Commission has approved Reblozyl for the treatment of: • Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy. • Adult patients with transfusion-dependent anemia associated with beta thalassemia. MEDALIST is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of Reblozyl plus best supportive care versus placebo plus BSC in adults with IPSS-R-defined very low-, low- or intermediate-risk non-del MDS. All patients were RBC transfusion-dependent and were either refractory or intolerant to prior erythropoiesis stimulating agent therapy, or were ESA naïve and unlikely to respond due to endogenous serum erythropoietin levels of ≥ 200 U/L, and had no prior treatment with disease modifying agents. The trial showed a statistically significant improvement in RBC transfusion burden with Reblozyl, the study’s primary endpoint, with 37.9% of patients treated with Reblozyl achieving independence from RBC transfusions for at least eight weeks during the first 24 weeks of the trial compared to 13.2% of patients on placebo.
  • 29. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable DSM (Netherland) debuts integrated portfolio of solutions for winning plant-based meat alternatives For any queries, Please write to marketing@itshades.com 23 Solution Description Royal DSM unveils its complete portfolio of integrated solutions for creating stand-out plant-based meat alternatives. The range is designed to enhance taste, texture and nutritional value, while also managing sodium content in meat alternative applications such as burgers, sausages and nuggets. Featuring a selection of yeast extracts, process flavors, hydrocolloids and nutritional ingredients, DSM’s full portfolio provides food producers with the tools they need to get to this thriving market fast, and meet growing consumer demand for an authentic, enjoyable and nourishing meat alternative experience. While the demand for meat continues to grow, the retail value of meat alternatives is expected to more than double this decade. However, as the trend gains traction, consumer expectations and preferences are becoming more sophisticated. It is no longer enough that a product is plant-based. Consumers are increasingly looking for an end-to-end experience that offers great taste, compelling texture and mouthfeel, as well as a rich nutritional profile. Meanwhile, they expect reduced levels of sodium in their foods – which is typically present in high quantities in meat alternative products. This presents a range of complex challenges for manufacturers in this space. DSM’s combined ingredient capabilities in taste, texture and nutrition not only enable meat alter-native producers to optimize the cost-performance ratio of their recipes, but also amplify front-of-pack claims thanks to DSM’s deep-rooted expertise into nutrition science.
  • 30. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Eisai (Japan) To Launch In-House Developed New Anti-Insomnia Drug Dayvigo® With Indication for Insomnia in Japan For any queries, Please write to marketing@itshades.com 24 Solution Description Eisai Co., Ltd. announced that it has launched its in-house-discovered and developed orexin receptor antagonist DAYVIGO® 2.5 mg, 5 mg, 10 mg tablets for treatment of insomnia in Japan. Eisai received marketing and manufacturing approval for this formulation on January 23, 2020, and the product was added to Japan’s National health Insurance drug price list. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors. DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm. The approval of DAYVIGO in Japan is based on findings from two pivotal Phase III studies1,2 in adult patients with insomnia, as well as evaluation of residual effects including middle of the night waking, next morning postural stability, and memory through Studies 1063 and 1084.
  • 31. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Eisai (Japan): New Fine Granule Formulation of Anti-Epileptic Drug Fycompa® Launched in Japan For any queries, Please write to marketing@itshades.com 25 Solution Description Eisai Co., Ltd. announced that it has launched a new fine granule formulation of its in-house-discovered antiepileptic drug Fycompa® in Japan. Eisai received marketing and manufacturing approval for this formulation, and the fine granule formulation was added to Japan’s National Health Insurance drug price list of the same year. In Japan, it is estimated that there are approximately 1 million patients with epilepsy. While epilepsy is a disease that may occur regardless of age, it is said that incidence is particularly high in children and the elderly. This newly launched fine granule formula was developed so that even patients who have difficulty taking tablets such as children or those who have difficulties in taking tablets due to reduced swallowing ability may take this drug. Additionally, greater ability to adjust dosage to match patients’ symptoms becomes possible. Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories and was developed in-house. It is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. In Japan, Fycompa is currently approved for monotherapy and adjunctive use in the treatment of partial-onset seizures in patients with epilepsy 4 years of age and older, as well as adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
  • 32. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Eisai (Japan) Receives Approval for Parkinson’s Disease Treatment Equfina® In South Korea For any queries, Please write to marketing@itshades.com 26 Solution Description Eisai Co., Ltd. announced that Eisai Korea Inc., Eisai’s subsidiary in South Korea, has received marketing approval of Parkinson’s disease treatment Equfina® for the indication of treatment of idiopathic Parkinson’s disease as adjunctive therapy with levodopa-containing products in patients with end of dose motor fluctuations from the regulatory authority in South Korea. The marketing authorization application for safinamide in South Korea was submitted in July 2019, and through the approval of this application, South Korea became the first country in Asia outside of Japan to grant marketing approval for safinamide. This approval is primarily based on a double-blind, placebo-controlled, phase III study in overseas countries, including South Korea, to evaluate the efficacy and safety of 24-week oral administration of the once-daily safinamide as an add-on to levodopa in patients with Parkinson’s disease with motor fluctuations. In the SETTLE study, the primary endpoint was the change in mean daily “on” time from baseline to 24 weeks of the treatment phase. Regarding the primary endpoint, safinamide increased the “on” time by 0.96 hours more than placebo, showing a statistically significant extension in “on” time. The most common three adverse drug reactions observed with patients with safinamide were dyskinesia, nausea and somnolence.
  • 33. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Kite (USA) Receives European Medicines Agency Approval for CAR T Cell Therapy Manufacturing Facility in Europe For any queries, Please write to marketing@itshades.com 27 Solution Description Kite, a Gilead Company announced it has received approval to implement a variation to the Yescarta® Marketing Authorization from the European Medicine Agency for end-to-end manufacturing. With this approval, Kite’s European manufacturing facility, designed and dedicated to the manufacture of individualized cell therapies, is now fully operational. Kite has nearly 90 qualified treatment centers in 16 countries across Europe and Israel. The new European facility sits next to one of Europe’s largest airports, Amsterdam Airport Schiphol. This central location, with its transport links to the region, will reduce the delivery time to and from treatment centers. The facility has the capacity to produce therapy for up to 4,000 patients per year. As the leader in engineered cell therapy, Kite has set a standard with an integrated state-of-the-art global manufacturing network that includes commercial manufacturing facilities in El Segundo, California and Amsterdam, and clinical manufacturing in Santa Monica, California and Gaithersburg, Maryland. Kite is also building a third commercial cell therapy manufacturing facility in Frederick County, Maryland, which will significantly expand the company’s ability to manufacture CAR T cell therapies. In addition to producing novel CAR T cell therapies, the clinical manufacturing network is also producing investigational T cell receptor therapies for evaluation in solid tumors.
  • 34. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable ViiV Healthcare (USA) announces US FDA approval for Rukobia, a first-in-class treatment for HIV in adults with few treatment options available For any queries, Please write to marketing@itshades.com 28 Solution Description ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration has approved Rukobia, 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral therapies in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations. Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at risk of progressing to AIDS and death and in great need of additional therapies. The approval was supported by data from the phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomized cohort, 60% of individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.
  • 35. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable GSK (UK) receives first regulatory approval for Duvroq in Japan for patients with anaemia due to chronic kidney disease For any queries, Please write to marketing@itshades.com 29 Solution Description GlaxoSmithKline plc announced the approval of a Japanese New Drug Application by the Ministry of Health, Labour and Welfare for Duvroq tablets, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of patients with anaemia due to chronic kidney disease. Anaemia is common in patients with CKD because the kidneys no longer produce adequate amounts of erythropoietin, a hormone involved in prompting the production of red blood cells.1 HIF-PHIs are a new class of drug that trigger the body’s adaptations to hypoxia (i.e. oxygen deprivation) and encourages the bone marrow to make more red blood cells and so reduce anaemia, thereby benefitting patients. The JNDA was primarily based on positive data from the phase III programme conducted in Japan. The studies evaluated Duvroq for the treatment of anaemia in patients across the spectrum of CKD from stages 3-5. This included patients on dialysis, including both hemo- and peritoneal dialysis, and those not on dialysis, regardless of prior anaemia treatment with erythropoiesis-stimulating agents. In contrast to current standard of care in patients with CKD which requires injections, Duvroq offers convenience with oral administration and flexibility with once-daily dosing for dialysis and non-dialysis patients.
  • 36. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Henry Schein Medical (USA) Announces Expansion of Medpod’s Telemedicine Solutions with Integration of VisualDx For any queries, Please write to marketing@itshades.com 30 Solution Description Henry Schein Medical, the U.S. medical business of Henry Schein, Inc. and exclusive distributor of Medpod, Inc.’s telemedicine solutions, announced the integration of VisualDx - a clinical decision support system - with Medpod’s technology infrastructure to help health care professionals better diagnose patients virtually. VisualDx is designed to enhance diagnostic accuracy, aid therapeutic decisions, and improve patient care, all critically important to health care professionals on the front lines of medicine. Medpod’s cloud-based software and modular infrastructure gives providers and operators the ability to deliver customizable, high-quality, and convenient care that meets the needs of patients who cannot visit a traditional office setting. With the integration of VisualDx’s clinical support, Medpod users can access a database of information written by a variety of medical experts; recognize disease variants; identify drug adverse events; and enhance patient education to help provide informed, accurate, and fast decision-making. The platform also assists users to make custom diagnoses as a result of having the ability to enter patient-specific information, such as age range, gender, symptoms and signs; search by disease for quick therapy and treatment options; review and compare a curated medical image library; enhance understanding of medication reactions; and share patient handouts via email. Clinicians can also earn Continuing Medical Education credits each time they use VisualDx as part of their subscription.
  • 37. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Illumina (USA) Launches TruSight Software Suite to Accelerate the Identification of Genetic Diseases For any queries, Please write to marketing@itshades.com 31 Solution Description Illumina, Inc. is bringing turn-key data analysis solutions to accelerate and facilitate the adoption of whole-genome sequencing with the launch of the TruSight™ Software Suite. TruSight Software delivers ready-made infrastructure to realize the full potential of whole-genome sequencing for rare genetic diseases. This new offering enables sample-to-report analysis for genetic disease testing, giving customers an integrated solution that focuses on one of the most challenging parts of the workflow, empowering researchers to go from 5 million variants to a small handful, in a rapid, scalable way. TruSight Software will make it easier for people to benefit from the valuable insights enabled by genomic sequencing. More than 250 million people are affected by rare genetic diseases globally. These conditions can be debilitating with families frequently spending upwards of five years being referred from doctor to doctor, enduring a diagnostic odyssey often fraught with misdiagnoses, inappropriate treatments and procedures, all in search for an underlying cause. These diagnostic odysseys are expensive. In the U.S. alone it is estimated that pediatric genetic diseases cost at least $14 billion every year. And, in some cases it’s a race against time, where an early diagnosis can dramatically improve patient outcomes – potentially even helping a young child live a healthier, fuller life. As one of the most comprehensive genetic tests available, whole-genome sequencing offers the potential to shorten the time and reduce the cost of identifying these genetic conditions, and the most likely to end the diagnostic odyssey.
  • 38. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Johnson & Johnson (USA) Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine For any queries, Please write to marketing@itshades.com 32 Solution Description Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is now collaborating with the World Health Organization on vaccine pre-qualification, which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need. Two Marketing Authorisation Applications were submitted to the European Medicines Agency for the vaccines composing the two-dose regimen, Zabdeno® and Mvabea®. Marketing Authorisation under exceptional circumstances has been granted following Accelerated Assessment of the MAAs and a positive opinion by the EMA’s Committee for Medicinal Products for Human Use. Janssen’s Ebola vaccine regimen is indicated for active immunization for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above. The worst Ebola outbreak to date was the West African epidemic, which caused nearly 30,000 cases and more than 11,000 deaths in 2014-2016. There are two outbreaks currently ongoing in the Democratic Republic of the Congo, the first of which began in 2018 and is the world’s second worst Ebola outbreak on record.
  • 39. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable LabCorp (USA) Launches First Digital COVID-19 Service That Improves the Doctor and Patient Experience For any queries, Please write to marketing@itshades.com 33 Solution Description LabCorp launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital service aimed at helping doctors protect patients by testing them for COVID-19 before surgeries and other important treatments. The service received Emergency Use Authorization by the U.S. Food and Drug Administration. The service enables a doctor to directly order a LabCorp At Home COVID-19 test collection kit for their patient through a digital interface with LabCorp. Once the order is placed, LabCorp will send the COVID-19 kit to the patient, who will perform the sample collection using a nasal swab and send it back to LabCorp via FedEx. LabCorp will then deliver the patient’s test results to the healthcare provider’s electronic medical record (EMR) and the patient’s LabCorp Patient Portal, making the process seamless for the doctor and patient. The result provides the doctor the information needed to make the appropriate clinical decision prior to proceeding with surgery or other treatment. LabCorp is piloting the service with select providers initially, and plans to make the service available to more health systems, hospitals, and surgical centres through the providers’ EMRs in coming weeks.
  • 40. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable LabCorp (USA) Introduces Xcellerate® COVID-19 Clinical Study Solution For any queries, Please write to marketing@itshades.com 34 Solution Description LabCorp., a leading global life sciences company that is deeply integrated in guiding patient care, announced that Covance, its drug development business, has deployed the Xcellerate® COVID-19 solution as part of its award-winning Xcellerate platform. Covance has developed a comprehensive approach to reinitiate ongoing research and start up new studies, with a focus on patient safety and study delivery. Designed in conjunction with Covance’s COVID-19 Operational Recovery Team, the Xcellerate® COVID-19 solution offers integrated data collection, actionable views of critical study data, COVID-19 targeted risk management and recovery assessment. Global clinical research has been disrupted by the COVID-19 pandemic. Specific impacts include studies being halted or paused and enrollment being delayed. Many clinical research sites around the world have restricted all but essential visits except for patient safety, with study monitoring conducted remotely where possible. As healthcare conditions improve globally, research sites are positioned to resume studies. The Xcellerate COVID-19 solution reinforces Covance’s tailored research recovery roadmap that combines central oversight and governance with local decision making and site centricity to address the complexity of the pandemic’s impact on research globally. The roadmap supports adaptive, agile and innovative approaches to maintain continuity, protect patients and preserve critical endpoints. In the longer term, Covance’s comprehensive approach to research recovery is designed to support patients, minimize the number of patients that drop out of studies, prevent missed visits to sites and optimize data integrity.
  • 41. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable LabCorp (USA) Launches New Neutralizing Antibody Test For any queries, Please write to marketing@itshades.com 35 Solution Description LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, announced the launch of a new test that can be used to assess the capacity of antibodies in patient plasma to inhibit the SARS-CoV-2 virus. This information could be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use. This neutralizing antibody test will be available to biopharmaceutical companies, hospitals, blood banks and other plasma-screening facilities. As the research for a safe and effective vaccine continues, some clinicians are relying on the serum collected from convalescent patients who had COVID-19 to support treatment of the severely ill. As research advances, the PhenoSense® assay may be an essential element in defining the neutralizing antibody activity correlated with the therapeutic efficacy of convalescent plasma administration, as well as the relative protective immunity of vaccine candidates. LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.
  • 42. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable XPOVIO, FDAApproved for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma, Available at Biologics by McKesson (USA) For any queries, Please write to marketing@itshades.com 36 Solution Description Biologics by McKesson, an independent specialty pharmacy specializing in oncology, rare diseases and other complex therapeutic areas, was selected by Karyopharm Therapeutics, Inc. as a specialty pharmacy provider for XPOVIO® for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the U.S. Food and Drug Administration’s Accelerated Approval Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. XPOVIO was approved by the FDA for this second cancer indication and is the company’s first-in-class, Selective Inhibitor of Nuclear Export compound. This treatment has been granted both Fast Track and Orphan Drug designations from the FDA. XPOVIO was previously approved as the first and only nuclear export inhibitor that blocks Exportin 1 and is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agent, and an anti-CD38 monoclonal antibody.
  • 43. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Merck (USA): LYNPARZA® Approved in the EU for Germline BRCA-mutated Metastatic Pancreatic Cancer For any queries, Please write to marketing@itshades.com 37 Solution Description AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that LYNPARZA has been approved in the European Union as a monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. The approval by the European Commission was based on results from the Phase 3 POLO trial, which were published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate of the most common cancers. Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation. LYNPARZA is approved in the U.S. and several other countries as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen, based on the Phase 3 POLO trial, with ongoing regulatory reviews in other jurisdictions.
  • 44. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable FDAApproves Merck’s (USA) KEYTRUDA® for First-Line Treatment of Patients with Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer For any queries, Please write to marketing@itshades.com 38 Solution Description Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% compared with chemotherapy, the current standard of care. In the study, treatment with KEYTRUDA also more than doubled median progression-free survival compared with chemotherapy versus 8.2 months. Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.
  • 45. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable FDAApproves Merck’s KEYTRUDA®(USA) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma that is Not Curable by Surgery or Radiation For any queries, Please write to marketing@itshades.com 39 Solution Description Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation. This approval is based on data from the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated meaningful efficacy and durability of response, with an objective response rate of 34%, including a complete response rate of 4% and a partial response rate of 31%. Among responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median duration of response had not been reached. Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.
  • 46. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable FDAApproves Merck’s GARDASIL 9 (USA)for the Prevention of Certain HPV-Related Head and Neck Cancers For any queries, Please write to marketing@itshades.com 40 Solution Description Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved an expanded indication for GARDASIL9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The trial is currently underway. Both men and women can be at risk for HPV-attributable oropharyngeal cancer; however, this cancer affects men five times more than women.1 For most people, HPV clears on its own. But, for those who don't clear the virus, it can cause certain cancers. Oropharyngeal cancer can arise as a result of HPV infection in the oropharynx, which includes the soft palate, side and back wall of the throat, tonsils, and back one-third of the tongue. According to a recent model published by the U.S. Centers for Disease Control and Prevention, HPV-attributable oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the U.S.
  • 47. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Novozymes (Denmark): New biological solution brings the natural umami flavor from plant proteins For any queries, Please write to marketing@itshades.com 41 Solution Description Novozymes has launched two new enzymes that enable food manufacturers to produce tasty, label-friendly meat alternatives with less salt. More and more consumers demand low-salt, savory products with excellent taste and based on natural and recognizable ingredients. At the same time, the rapidly growing market1 for plant-based meat analogues calls for vegetarian ways to create the umami taste of meat. To round off and enhance the umami taste of savory products such as meat analogues, soups, sauces and snacks while enabling salt reduction, food producers have the options to use yeast extract or hydrolysed vegetable proteins. Yeast extract is a natural source of umami. But some consumers tend to shy away from products labelled with this ingredient as it is not perceived kitchen-cupboard-like, just as some may perceive an off-taste. Traditional HVP is free from any off-taste from yeast but is produced by means of chemicals and high energy consumption; processes which are often incompatible with natural claims and consumer preferences.
  • 48. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Pfizer (USA): FDAApproves Bavencio As First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma For any queries, Please write to marketing@itshades.com 42 Solution Description EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. announced that the US Food and Drug Administration has approved the supplemental Biologics License Application for BAVENCIO® for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival with BAVENCIO as first-line maintenance plus best supportive care compared with BSC alone: 21.4 months vs. 14.3 months. This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population. OS was measured from the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months. The JAVELIN Bladder 100 results were presented at the ASCO 2020 Virtual Scientific Meeting. Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment, and only 5% of patients with metastatic disease at diagnosis will live longer than five years.
  • 49. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Pfizer (USA): European Commission Approves Daurismo™ For Certain Adult Patients with Newly Diagnosed Acute Myeloid Leukemia For any queries, Please write to marketing@itshades.com 43 Solution Description Pfizer Inc. announced that the European Commission approved DAURISMO™, a Hedgehog pathway inhibitor, in combination with low-dose cytarabine, a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia in adult patients who are not candidates for standard chemotherapy. The approval follows the medicine’s positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency earlier this year, as well as the medicine’s approval by the U.S. Food and Drug Administration in November 2018. The European Commission’s approval of DAURISMO is based on results from the Phase 2 BRIGHT 1003 trial, which showed DAURISMO nearly doubled median overall survival compared to LDAC alone in patients with previously untreated AML who were not eligible for intensive chemotherapy. The difference represented a 54 percent reduction in the risk of death for patients treated with DAURISMO plus LDAC.
  • 50. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable FDA approves Roche’s Phesgo (Switzerland) for HER2-positive breast cancer For any queries, Please write to marketing@itshades.com 44 Solution Description Roche announced that the US Food and Drug Administration has approved Phesgo™, a fixed-dose combination of Perjeta® and Herceptin® with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection. Phesgo is available in one single-dose vial. Administration can take approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines. Phesgo can be administered by a healthcare professional in a treatment centre or at a patient’s home. The approval is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval, when compared to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhoea and anaemia.
  • 51. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Roche’s ENSPRYNG® (Switzerland) approved in Japan for adults and children with neuromyelitis optica spectrum disorder For any queries, Please write to marketing@itshades.com 45 Solution Description Roche announced that Japan’s Ministry of Health, Labour and Welfare has approved ENSPRYNG® for the prevention of relapses of neuromyelitis optica spectrum disorder, including NMO, for aquaporin-4 antibody seropositive adults and children. ENSPRYNG demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy, and is dosed subcutaneously every four weeks. NMOSD is commonly associated with pathogenic antibodies that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve, spinal cord and brain. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of NMOSD patients, and these patients tend to experience a more severe disease course. Although most cases of NMOSD can be confirmed through a diagnostic test, up to 30% of people living with the condition are still frequently misdiagnosed with multiple sclerosis. ENSPRYNG is a humanised monoclonal antibody that targets the IL-6 receptor, believed to play a key role in the inflammation that occurs in people with NMOSD. ENSPRYNG was designed by Chugai Pharmaceutical Co., a member of the Roche group, using novel antibody recycling technology. Compared to conventional technology, this allows for longer duration of antibody circulation and maximum inhibition of IL-6 signalling, while minimising safety risks in a chronic disease setting. People with NMOSD experience unpredictable, severe relapses directly causing cumulative, irreversible neurological damage and disability. Preventing relapses through early treatment can have a positive impact on preventing disability and is the primary goal for NMOSD disease management.
  • 52. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Roche (Switzerland) improves speed and accuracy of non-small cell lung cancer diagnosis with launch of automated digital pathology algorithm For any queries, Please write to marketing@itshades.com 46 Solution Description Roche announced the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 image analysis for non-small cell lung cancer. The algorithm provides pathologists with automated assessments of scanned slide images that are objective and reproducible and have the potential to aid diagnosis and, ultimately, targeted treatment options for patients. Validated on the VENTANA PD-L1 Assay, the algorithm is ready-to-use and integrated within the Roche uPath enterprise software, a universal digital platform for case management, collaboration and reporting. This algorithm will help pathologists to quickly determine whether tumours are positive for the PD-L1 biomarker, highlighting positively and negatively stained tumour cells with a clear visual overlay for easy reference. Patients with tumours that are positive for the PD-L1 biomarker may be eligible for targeted treatment. The algorithm’s whole-slide automated analysis uses artificial intelligence to provide, with one-click, an actionable assessment of the scanned slide images that is objective and reproducible. The uPath PD-L1 image analysis algorithm for digital pathology is for use on uPath enterprise software.
  • 53. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable Thermo Fisher Scientific (USA) Launches New MAS Omni Infectious Disease Quality Controls For any queries, Please write to marketing@itshades.com 47 Solution Description Thermo Fisher Scientific, the world leader in serving science, announced the availability of the Thermo Scientific MAS Omni Infectious Disease quality control sets for monitoring serological assays for analytes such as HIV 1&2, Hepatitis B & C virus, Syphilis and HTLV I/II. Serology testing for infectious diseases continues to be on the rise and newer instrument platforms are offering serology markers with improved sensitivity than previously available. In addition, there is continued progression with infectious disease screening protocols requiring serology testing for diagnosis, monitoring and treatment of infectious agents. The Thermo Scientific MAS Omni Infectious positive and negative quality controls are third-party, independent external controls used to assess the performance of serological assays for infectious diseases. Our new control set supports assays for HIV, Hepatitis C, Hepatitis B, HTLV and Syphilis. As with all Thermo Scientific MAS Quality Controls users can efficiently monitor assay performance, streamline operations and potentially reduce your spending without sacrificing quality or throughput.
  • 54. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nib Solution Updates IT Shades Engage & Enable iSPA (USA) Workflow Helps Pharmaceutical Companies Bring New Drugs to Market Faster For any queries, Please write to marketing@itshades.com 48 Solution Description Thermo Fisher Scientific has released the Thermo Scientific iSPA Workflow, the first commercially available single particle analysis workflow solution. As pharmaceutical labs turn to cryo-electron microscopy to uncover the structures of difficult-to-crystalize molecules at near atomic resolution, they need ways to increase their productivity to more quickly move from early drug discovery to clinical trials. iSPA Workflow solves this problem by providing an easy-to-use, highly productive and automation-enhanced solution to match the pace of drug discovery. Developed with input from users in the pharmaceutical industry, this SPA dedicated workflow is designed for structural biologists of all experience levels who need to deliver structural insights. With reduced manual steps, the workflow is simplified and preparing the microscope for data collection takes less than 30 minutes. Companies can also increase productivity by using its unattended data collection feature, which allows them to collect data from multiple grids while not at the instrument. The solution offers uptime reliability of instruments, helping users avoid time spent troubleshooting equipment problems. The flagship of the iSPA workflow is the Thermo Scientific Krios Rx, a high-end cryo-transmission electron microscope designed specifically for ease-of-use and enhanced automation. Automation facilitates unattended data collection, and requires minimal expertise to operate the microscope, freeing up time to focus on results.
  • 55. IT Shades Engage & Enable For any queries, Please write to marketing@itshades.com Rewards & Recognition Updates Healthcare Industry
  • 56. R & R Updates IT Shades Engage & Enable CVS Health (USA) named ‘Presenting and Official Health and Wellness Sponsor’ for the Washington Spirit professional soccer team For any queries, Please write to marketing@itshades.com 49 The Washington Spirit is proud to announce CVS Health as their new presenting and official health and wellness sponsor for the 2020 season. The sponsorship reflects a shared goal of building healthier communities, with a focus on the health and wellness of women and underserved youth. CVS Health will be the presenting sponsor for all team youth community initiatives, which encompass discussions of healthy lifestyle as well as nutrition, mental resiliency, skills challenges and other activities. The CVS Health brand will be featured on the front of the team jersey, around the club and during designated Spirit home games during the 2020 NWSL Challenge Cup. In addition, CVS Pharmacy ExtraCare® card holders will be eligible for discounts in the team store. CVS Health is one of many businesses to join the Washington Spirit family in the 2019–2020 offseason. This growing group of sponsors, in collaboration with the Spirit, will help continue to grow the game of women’s soccer in the Washington, D.C. metro area. CVS Health employees are united around a common goal of becoming the most consumer-centric health company in the world. They're evolving based on changing consumer needs and meeting people where they are, whether that's in the community at one of their nearly 10,000 local touchpoints, in the home, or in the palm of their hand. R&R Description
  • 57. R & R Updates IT Shades Engage & Enable CVS Health (USA) recognized as one of the ‘50 most community-minded companies’ by Points of Light For any queries, Please write to marketing@itshades.com 50 CVS Health has been named a 2020 honoree of The Civic 50 by Points of Light, one of the world’s largest organizations dedicated to volunteer service. This marks the fourth consecutive year that CVS Health has been named to The Civic 50. The award recognizes CVS Health as one of the 50 most community-minded companies in the United States. The Civic 50 provides a national standard for superior corporate citizenship and showcases how companies can use their time, skills and resources to impact their communities. The Civic 50 honorees are public and private companies with U.S. operations and revenues of $1 billion or more, and are selected based on four dimensions of their U.S. community engagement program, including investment, integration, institutionalization and impact. In 2019, CVS Health employees donated more than $12 million worth of volunteer time. From team service projects to serving on boards as mentors and company hosted volunteer activities, employees participated in thousands of volunteer events representing CVS Health in their local communities. R&R Description
  • 58. IT Shades Engage & Enable For any queries, Please write to marketing@itshades.com Customer Success Healthcare Industry
  • 59. Customer Success Updates IT Shades Engage & Enable AstraZeneca (UK) to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit For any queries, Please write to marketing@itshades.com 51 AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. With agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe. AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The Company is seeking to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support access to the vaccine at no profit during the pandemic. The Company has recently completed similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance for 700 million doses, and it agreed a licence with the Serum Institute of India for the supply of an additional one billion doses, principally for low- and middle-income countries. Total manufacturing capacity currently stands at two billion doses. Description
  • 60. Customer Success Updates IT Shades Engage & Enable Cigna (USA), Huntsville Hospital Health System Reach Agreement to Provide Value-Based Care to Medicare Advantage Customers in Northern Alabama For any queries, Please write to marketing@itshades.com 52 Cigna and Huntsville Hospital Health System have reached an agreement under which the organizations will collaborate to provide value-based care to customers of Cigna Medicare Advantage plans. Value-based care places quality above quantity with a particular focus on proactive, coordinated care that prioritizes wellness and disease prevention. Huntsville Hospital has operated as a community-owned hospital since 1895. Today, the hospital is the second largest facility in the state and the centerpiece of a multi-hospital Health System across north Alabama, serving as the regional referral and trauma center for more than a million residents of the Tennessee Valley. Huntsville Hospital Health System operates hospitals in Huntsville, Madison, Athens, Decatur, Boaz-Albertville, Guntersville-Arab, Sheffield and Red Bay. The Health System includes more than 2,000 licensed beds for patient care and employs more than 15,000 persons. Cigna Corporation is a global health service company dedicated to improving the health, well-being and peace of mind of those we serve. Cigna delivers choice, predictability, affordability and access to quality care through integrated capabilities and connected, personalized solutions that advance whole person health. Description
  • 61. Customer Success Updates IT Shades Engage & Enable Regeneron (USA) Announces Manufacturing and Supply Agreement for Barda And U.S. Department of Defense for Regn-Cov2 Anti-Viral Antibody Cocktail For any queries, Please write to marketing@itshades.com 53 Regeneron Pharmaceuticals, Inc. announced that, as part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2. REGN-COV2 is Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 infection. Regeneron began scaling up manufacturing of REGN-COV2 at business risk in spring of 2020. This agreement supports continued manufacturing so that the product could be made available immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration grants Emergency Use Authorization or product approval. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses or prevention doses available from these lots in total. Initial doses may be ready as early as end of summer. If EUA or product approval is granted, the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution. Description
  • 62. Customer Success Updates IT Shades Engage & Enable Vertex (USA) Announces Expansion of Reimbursement Agreement with NHS England to Include KAFTRIO® in Combination With KALYDECO® For any queries, Please write to marketing@itshades.com 54 Regeneron Pharmaceuticals, Inc. announced that, as part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2. REGN-COV2 is Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 infection. Regeneron began scaling up manufacturing of REGN-COV2 at business risk in spring of 2020. This agreement supports continued manufacturing so that the product could be made available immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration grants Emergency Use Authorization or product approval. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses or prevention doses available from these lots in total. Initial doses may be ready as early as end of summer. If EUA or product approval is granted, the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution. Description
  • 63. Customer Success Updates IT Shades Engage & Enable Vertex (USA) Announces Expansion of Reimbursement Agreement with NHS England to Include KAFTRIO® in Combination With KALYDECO® For any queries, Please write to marketing@itshades.com 55 Vertex Pharmaceuticals Incorporated announced that it has expanded its reimbursement agreement with NHS England for Vertex’s cystic fibrosis medicines to include KAFTRIO®, in a combination regimen with KALYDECO® 150 mg, ahead of the medicine’s anticipated approval by the European Commission. The new expanded agreement includes reimbursed access to Vertex’s currently licensed medicines — KALYDECO®, ORKAMBI® and SYMKEVI®, as well as the triple combination therapy if approved — and any future additional licensed indications for all of these medicines. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently adopted a positive opinion for KAFTRIO® in a combination regimen with KALYDECO® 150 mg to treat people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation or two F508del mutations in the cystic fibrosis transmembrane conductance regulator gene. Description