I-Bytes Healthcare Industry

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I-Bytes
Healthcare
June Edition 2020
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Table of Contents
1. Financial, M & A Updates..................................................................................................................................1
2. Solution Updates.................................................................................................................................................6
3. Rewards and Recognition Updates..................................................................................................................37
4. Customer Success Updates................................................................................................................................40
5. Partnership Ecosystem Updates.......................................................................................................................45
6. Miscellaneous Updates......................................................................................................................................73

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Financial, M & A
Updates Healthcare Industry

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Financial, M&A Updates
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DSM (Netherland) to add world-leading animal nutrition and health specialty
businesses with acquisition of Erber Group
Royal DSM, a global science-based company in Nutrition, Health and
Sustainable Living, announces that it has reached agreement to acquire Erber
Group for an enterprise value of €980m. The value of the transaction represents
an EV/EBITDA multiple of about 14x the 2020 EBITDA. The transaction –
which excludes two smaller units in the Erber Group – is expected to be earnings
enhancing in the first year upon completion. Romer Labs also complements
DSM’s human nutrition and health offering to food industry customers. Sanphar
and EFB, representing 7% of Erber Group’s total sales, are not included in this
transaction. The acquired businesses have combined sales of €330m and an
Adjusted EBITDA margin above 20% for the twelve months to the end of March
2020, with a high single-digit organic sales growth rate over the past 5 years. The
acquisition will be debt financed, with committed bridge financing in place. DSM
continues to benefit from a strong balance sheet and remains committed to
maintaining a strong investment grade credit profile.
Executive Commentary
Co-CEOs of DSM, said: “These are great businesses with strong and
sustained track records of profitable growth and attractive margins. Biomin
and Romer Labs will help strengthen and accelerate the growth of our
specialty animal nutrition and health offering, including our big data and
diagnostic capabilities, and it is exciting to be entrusted to take these
family-founded businesses forward. It was immediately clear to us that the
people at Erber Group share our purpose-led mission and will make a
wonderful addition to DSM”.
Description
1

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Grifols (Spain) acquires parcel in Lliçà de Vall to grow the company’s production
facilities
Grifols, one of the leading companies in the production of plasma-derived medicines
and leader in the development of innovative diagnostic solutions,has formalized the
acquisition of 517,000 square feet in the municipality of Lliçà de Vall to grow its
industrial capacity in Barcelona. The agreement that today was finally closed was
supposed to occur in 2018, leading to a two-year delay in the start of the project.
Specifically, the land is located in the Can Gurri area, adjacent to the Llevant
Industrial Park in Parets del Vallès, where Grifols opened its first plant in 1972 and
where currently the company has a large part of its manufacturing facilities in the
country. Construction and reparceling of the new industrial park have already begun.
In a first phase, Grifols expects to invest 130 million Euros in the building of the new
production facilities to strengthen the growth of the Bioscience division, specialized
in the production of plasma-derived medicines. It also expects to increase the
manufacturing, research and logistical capabilities of the Diagnostic division, a
global standard in transfusion medicine.
“The acquisition of this land in Lliçà de Vall forms part of our commitment to
investing locally and generating high-skill employment in the region, in which
we’ve had a presence for nearly 50 years,” said VP Global Facilities, who added:
“The new facilities will enable us to grow in the following years, and we’ll be
poised to take advantage of new expansion opportunities.”
Description
1

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DTE Energy (USA) to Invest in Wayne County Environment Improvement
Projects
DTE Energy said it will invest $7.5 million dollars to support environmental
and sustainable improvements in Wayne County, Mich. The investment is a
key part of an agreement reached with the Environmental Protection Agency
and the Sierra Club that resolves an ongoing dispute over how the EPA’s new
source reviews rules would apply to new emission control investments for
coal plant operations. The agreement enables DTE Electric to continue its
progress toward net zero carbon emissions by 2050. DTE will also assemble a
Community Environmental Action Committee, made up of community and
university representatives who will guide the deployment of funds.
Projects determined by the committee may include:
• An urban solar array
• Urban foresting and farming
• Energy reduction initiatives
• Wildlife habitat restoration and education programs
“Our intent from the beginning of this process has been to reduce
emissions, and this agreement allows us to involve the community to do
even more, said vice president, Environment Management and Resources
for DTE Energy. We want to thank the EPA and the Sierra Club for
working with us. This action by all parties will further improve the quality
of life for residents of Wayne County.”
3
Key Financial Highlights

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Merck (USA) to Acquire Themis
Merck, known as MSD outside the United States and Canada, and Themis, a
company focused on vaccines and immune-modulation therapies for infectious
diseases and cancer, announced that the companies have entered into a definitive
agreement under which Merck, through a subsidiary, will acquire privately-held
Themis. Themis has a broad pipeline of vaccine candidates and
immune-modulator therapies developed 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.
“Building on the pioneering work of the Institut Pasteur, the Themis team has
established specialized expertise that complements Merck’s own capabilities
in the discovery, development, manufacturing and global distribution of
vaccines, said President, Merck Research Laboratories. We are eager to
combine our strengths both to develop an effective COVID-19 vaccine in the
near term and to build a pandemic preparedness capability directed toward
emerging agents that pose a future epidemic threat.”
Description
4

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Roche (Switzerland) acquires Stratos Genomics to further develop DNA based
sequencing for diagnostic use
Solutions Roche announced that it has acquired Stratos Genomics, an
early-stage sequencing technology company to advance the development
of Roche’s nanopore sequencer. The acquisition provides Roche access
to Stratos Genomics unique chemistry, Sequencing by Expansion. The
Roche nanopore sequencer, once developed, will utilize a novel
approach that combines electronic and biological components to
sequence DNA for fast, flexible and cost-effective clinical diagnostic
testing. The addition of the SBX chemistry, once fully developed, is
expected to provide the healthcare community an affordable, fast and
flexible result, for multiple targeted clinical applications as well as whole
exome and whole genome sequencing.
“Roche is dedicated to creating innovative diagnostics for the most
challenging clinical conditions with techniques that are tailored to
individual genetic and disease profiles. These solutions address the
demands of research and clinical practice to deliver on the promise of
personalized healthcare for patients, said CEO Roche Diagnostics.
We look forward to further advancing our sequencing technology as
we move to the next generation of healthcare and welcome the
world-class scientists and employees from Stratos Genomics to
Roche.”
Description
5

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Solutions Updates
Healthcare Industry

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Solution Updates
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CVS Pharmacy (USA) launches more than 80 new and exclusive wellness products
in easy-to-recycle packaging
6
Solution Description
CVS Pharmacy announced the roll out of more than 80 new products under the Live Better™ by CVS Health brand. The retailer also committed
to ensuring all packaging in the expanded health and wellness brand is at least 80% recyclable. The assortment will span nine categories and make
some of the most sought-after trends in the wellness space more accessible to consumers at a competitive price. In addition to products featuring
popular and emerging ingredients such as elderberry, ashwagandha, turmeric, kelp, maca, ginseng and charcoal, many are also labeled
USDA-certified organic, non-GMO project-certified, gluten-free, and cruelty-free or vegan. The brand calls out unique ingredient details, and the
rich back stories of how some of the products were sourced and sustainably manufactured can be read on the packaging or online. In addition to
the roll out of new Live Better products, 30 new better-for-you choices were added to the popular Gold Emblem and Gold Emblem Abound snack
and grocery lines, including exotic flavors, indulgent ingredients and unique product forms. Examples include organic chili lime dried mango,
probiotic apricots, plantain chips, sesame tahini cashews, and spreadable honey.

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Solution Updates
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Baxter (USA) Receives CE Marking and Australian Regulatory Approval for Evo
IQ Syringe Infusion System, Building on Smart Pump Platform
7
Baxter International Inc., a leader in innovative technology for medication delivery, announced CE marking and regulatory approval from
Australia’s Therapeutic Goods Administration for the Evo IQ Syringe Infusion System. The company expects hospitals in the United Kingdom,
Ireland, Greece, Australia and New Zealand to be among the first to receive the new system, with additional countries to follow in a series of
planned regulatory submissions. The Evo IQ Syringe Infusion System can be used to deliver small volumes of medications and other fluids to
patients in a controlled manner. The device joins the Evo IQ large volumetric pump as part of the Evo IQ Infusion Platform, a suite of smart pumps
that helps enable clinicians to utilize the technology that helps meet a patient’s specific needs. With patient safety and clinician efficiency central
to its design, the Evo IQ Syringe Infusion System is supported by Baxter’s web-based Dose IQ Safety Software and wireless IQ Enterprise
Connectivity Suite to help reduce potentially harmful infusion programming errors. It also features a modern interface, intuitive clinical workflows
and an advanced set portfolio to facilitate increased compliance and efficiency for clinicians.

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Solution Updates
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Boston Scientific (USA) Receives Medicare Transitional Pass-Through Payment for
the EXALT™ Model D Single-Use Duodenoscope
8
Boston Scientific announced that the Centers for Medicare & Medicaid Services have approved its application for a transitional pass-through payment
category to describe single-use endoscopes, including the EXALT™ Model D Single-Use Duodenoscope, under the Medicare hospital outpatient
prospective payment system. The intent of TPT payment is to facilitate Medicare beneficiary access to the advantages of new and innovative devices
by allowing for adequate payment for these new devices while the necessary cost data is collected to incorporate the costs for these devices into the
procedure Ambulatory Payment Classifications rate. The new device transitional pass-through code may be used to bill for EXALT Model D when it is
used in treatment of Medicare beneficiaries in the hospital. The FDA granted EXALT Model D its Breakthrough Devices Designation through a
program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis
for life-threatening or irreversibly debilitating diseases or conditions. Breakthrough Device Designation provides patients more timely access to novel
medical devices such as Exalt Model D. CMS has provided an alternative pathway for innovative technologies that have received FDA marketing
authorization and Breakthrough Devices Designation to qualify for device pass-through payment. EXALT Model D is among the first devices to receive
TPT approval by CMS via this pathway.

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Solution Updates
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Boston Scientific (USA) Launches DIRECTSENSE™ Technology
9
Boston Scientific announced the U.S. launch of the DIRECTSENSE™ Technology, a tool for monitoring the effect of radiofrequency energy
delivery during cardiac ablation procedures. Available on the RHYTHMIA HDx™ Mapping System, the DIRECTSENSE Technology, which
received U.S. Food and Drug Administration approval in April, is the only tool to monitor changes in local impedance – electrical resistance
– around the tip of the INTELLANAV™ MiFi Open-Irrigated ablation catheter, offering physicians an additional measurement of therapy
effect during an ablation. Ablation is a treatment option for patients with cardiac arrhythmias in which physicians use a catheter to create
lesions and destroy heart tissue that causes abnormal rhythms. The DIRECTSENSE Technology provides data on the impedance around the
catheter tip to measure the ability of the tissue to respond to RF energy before physicians deliver therapy. During ablation, the tool tracks the
change in local impedance which, in conjunction with other measures, offers physicians a distinct understanding of tissue characteristics and
how they are affecting that tissue. These insights may indicate temperature change in the tissue, helping to reduce the chances of over-ablation
and avoid complications.

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Bristol Myers Squibb (USA) Announces Commercial Launch and Availability of
ZEPOSIA®, a New Oral Treatment for Relapsing Forms of Multiple Sclerosis
10
Bristol Myers Squibb announced that ZEPOSIA® 0.92 mg, a new once-daily oral medication for adults for the treatment of relapsing forms of
multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, is now
commercially available in the U.S. ZEPOSIA was approved by the U.S. Food and Drug Administration. ZEPOSIA is contraindicated in patients
who in the last six months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensate heart failure
requiring hospitalization, or Class III/IV heart failure; patients who have a presence of Mobitz type II second or third-degree atrioventricular block,
sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker; patients with severe untreated sleep apnea; and patients taking
a monoamine oxidase inhibitor. ZEPOSIA is associated with the following Warnings and Precautions: increased risk of infections,
bradyarrhythmia and atrioventricular conduction delays, liver injury, fetal risk, increased blood pressure, respiratory effects, macular edema,
posterior reversible encephalopathy syndrome, additive immunosuppressive effects from prior immune-modulating treatments, severe increase in
disability after stopping ZEPOSIA, and immune system effects after stopping ZEPOSIA.1 Please see Important Safety Information for additional
details.

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Bristol Myers Squibb (USA) Receives European Commission Approval for Zeposia for the Treatment of
Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease
11
Bristol Myers Squibb announced that the European Commission has approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis with
active disease as defined by clinical or imaging features. With the EC marketing authorization, Zeposia, an oral medication taken once daily, becomes the only approved
sphingosine-1-phosphate (S1P) receptor modulator for RRMS patients with active disease. The approval is based on data from the SUNBEAM™ and RADIANCE™
Part B clinical trials showing that, as compared to AVONEX®, Zeposia delivered powerful efficacy as measured by annualized relapse rate, as well as on the number
and size of brain lesions. The approval was based on data from the randomized, active-controlled Phase 3 SUNBEAM and RADIANCE Part B clinical trials, which
enrolled more than 2,600 patients across 150 sites in more than 20 countries.
Key findings from the trials include:
• Zeposia demonstrated a relative reduction in ARR versus AVONEX of 48% through one year in the SUNBEAM study and 38% at two years in the RADIANCE study.
• At one year in the SUNBEAM study, treatment with Zeposia reduced the number of T1‑weighted gadolinium-enhanced brain lesions more than AVONEX, a relative
reduction of 63%, and reduced the number of new or enlarging T2 brain lesions (1.47 versus 2.84), a relative reduction of 48%.
• At two years in the RADIANCE study, treatment with Zeposia reduced the number of T1‑weighted GdE brain lesions more than AVONEX, a relative reduction of 53%.
Zeposia also reduced the number of new or enlarging T2 lesions versus AVONEX (1.84 versus 3.18), a relative reduction of 42%.

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U.S. Food and Drug Administration Approves Opdivo® + Yervoy® (USA) Combined with Limited
Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer
12
Bristol Myers Squibb announced that Opdivo 360 mg plus Yervoy 1 mg/kg given with two cycles of platinum-doublet chemotherapy was approved by
the U.S. Food and Drug Administration for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cance with no EGFR
or ALK genomic tumor aberrations.1 The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1
expression.1 This application was reviewed under the FDA’s Real-Time Oncology Review pilot program, which aims to ensure that safe and effective
treatments are available to patients as early as possible. , the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic
NSCLC whose tumors express PD-L1≥1% as determined by an FDA-approved test. Opdivo is associated with the following Warnings and Precautions
including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis,
other adverse reactions; infusion-related reactions; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is
added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1,4 Please see the Important Safety
Information section below, including Boxed WARNING for Yervoy regarding immune-mediated adverse reactions.4

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Cigna (USA) Expands and Extends Its Covid-19 Relief Efforts for Medicare
Advantage and Individual and Family Plans
13
Cigna is expanding its support for customers during this unprecedented COVID-19 pandemic by eliminating cost-sharing for all
primary care, specialty care and behavioral health care in-office or telehealth visits for COVID-19 and non-COVID-19 care. This
expansion applies to all U.S. customers enrolled in Cigna's Medicare Advantage and Individual and Family Plans, including those
sold on the Individual Marketplace. Additionally, Cigna is making enhancements to its Medicare Advantage meal plan benefits
to further protect customers during this pandemic and underscore the company's continued commitment to enabling access to
simple, affordable and predictable health care. Effective immediately, Cigna is waiving all cost-sharing for in-network medical
or behavioral telehealth visits for customers in the U.S. covered by Medicare Advantage and Individual and Family Plans. This
waiver further supports customers and the medical community as we work together in preventing and treating those with
COVID-19, as well as continuing to provide alternatives to access for all other health and wellness needs.

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Cigna (USA) Adds Talkspace to Its Rapidly-Expanding Virtual Provider
Network
14
Cigna is making it simpler and more convenient for its customers to access an expanded suite of virtual support services for mental and emotional health. May marks Mental
Health Awareness month and effective, Cigna's 14 million customers enrolled in employer-sponsored plans can talk and text with licensed therapists, who are available
on-demand. In addition, customers who are facing issues related to anxiety, depression and burnout, and/or who are experiencing substance use or obsessive compulsive
disorders, will also have broader access to virtual treatment services through an expanded network of providers.
Cigna is also launching the following virtual care providers in select states to deliver more support for mental health needs for customers:
• Anxiety, Depression and Burnout: Through a 12-week app-based program, Cigna customers will receive daily support from licensed clinicians and anonymous peers to treat
anxiety, depression and burnout. The program is conducted through Meru Health and is available to customers in Arizona, California, and Colorado.
• Substance Use Recovery: Cigna customers can access substance use recovery support by connecting with certified peer support specialists virtually through a partnership with
MAP Health Management. Program is available to customers in Connecticut, Florida, Illinois, Maryland, New Jersey, New York, Pennsylvania, Texas, Virginia, and
Washington, D.C.
• Obsessive Compulsive Disorder: Customers who are diagnosed with obsessive compulsive disorder will have access to NOCD, a treatment program led by a licensed,
OCD-trained therapist with live video appointments and support in-between sessions by messaging the therapist and leveraging the platform's digital tools. Program is available
to customers in California, Michigan, and North Carolina.

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Daiichi Sankyo (Japan) Launches ENHERTU® in Japan for Patients with
HER2 Positive Unrespectable or Metastatic Breast Cancer
15
Daiichi Sankyo Company, Limited announced the launch of ENHERTU®, a HER2 directed antibody drug conjugate, in Japan for the
treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy. Marketing approval of
ENHERTU by Japan’s Ministry of Health, Labor, and Welfar in March 2020 was based on the results of the open-label, single-arm,
pivotal phase 2 DESTINY-Breast trial that demonstrated a confirmed objective response rate of 64.1% [95% CI: 56.3-71.3] in the
response evaluable set of 107 of 167 patients, which included 26 Japanese women, at a data cut-off of March 21, 2019. ENHERTU
is approved in Japan with a Warning for Interstitial Lung Disease. As cases of ILD, including fatal cases, have occurred in
ENHERTU-treated patients, ENHERTU is to be used in close collaboration with a respiratory disease expert. Closely observe
patients during therapy by monitoring for early signs or symptoms of ILD and regularly perform peripheral artery oxygen saturation
tests, chest X-ray scans and chest CT scans.

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DSM (Netherland) introduces Again™, commercial carpet designed for
circularity
16
Royal DSM, a global science-based company active in Nutrition, Health and Sustainable Living, announced that DSM-Niaga launches the Again™
carpet collection. Again™ is a commercial broadloom carpet designed for circularity and is specifically meant for office use. The carpet is unique in
two ways. It is made of recycled materials and it can be recycled into new carpet after use. What’s more, it meets commercial carpet highest quality
standards. Products made with Niaga® technology are simple, clean and reversible thanks to our proprietary click-unclick adhesive. They contribute to
healthy living and working environments. Again™ commercial office carpet is distinctively marked by our Niaga® tag and is our latest innovation
designed for circularity. In Europe alone, 1.6 billion tons of carpet is trashed annually, 95% of which ends up in landfill and incineration. Again™ is an
answer to this dire situation. DSM introduces Again™, commercial carpet designed for circularity. It is produced with just two materials, polyamide 6
and polyester. This makes it free of both volatile organic compounds and toxic flame retardants. What’s more, Again™ carpet’s face fibers and
secondary backing are made of 100% recycled materials. Because of its modular design, its materials can be regained, recycled and reused, again and
again. By scanning the Again™ carpet’s Niaga® tag, you gain access to an overview of the materials used to produce the carpet as well as recycling
instructions.

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Royal DSM (Netherland) Open collaborative platform UNITE4COVID
launched to accelerate Covid-19 solutions
17
Royal DSM, a global purpose-led, science-based company in Nutrition, Health and Sustainable Living, announces the launch of UNITE4COVID, a
digital, open, collaborative marketplace designed to provide solutions for healthcare professionals, as well as a forum and collaboration hub for
inventors, manufacturers and certification labs in the fight against corona. In response to the COVID-19 pandemic, the manufacturing industry
continues to provide help to relieve the urgent need for personal protective equipment and other safety equipment. From materials to production,
manufacturers are coming together to help relieve the urgent need for medical supplies, equipment and replacement parts. To connect those who wish
to help with those who seek help, DSM has launched a digital platform, UNITE4COVID.org. The platform makes finding approved COVID-19
solutions easier by providing transparency on approved COVID-19 solutions. Healthcare professionals as well as organizations, institutions and
companies looking to protect their patients, employees and customers can access UNITE4COVID to see and request the currently available solutions.
On the other hand, solution providers - from inventors to production hubs - can utilize the platform to share ideas, solutions, capacity and more. The
platform brings together players in additive and traditional manufacturing industries in one collaborative marketplace, where they find a digital
collaboration space, project management, approval status tracking and allows quick assessment on cost, availability and timing.

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Eisai (Japan) Launches New Insomnia Drug Dayvigo™ Civ In The United
States As A Treatment Option For Adults With Insomnia
18
Eisai Co., Ltd. announced that its U.S. subsidiary Eisai Inc. has launched its in-house discovered orexin receptor antagonist DAYVIGO™ CIV for the
treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance in the U.S. Discovered at Eisai’s Tsukuba
Research Laboratories and developed in-house, DAYVIGO is a small-molecule compound. The mechanism of action in the treatment of insomnia is
presumed to be through antagonism of orexin receptors1. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding
of wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R is thought to suppress wake drive. Lemborexant binds
to orexin receptors OX1R and OX2R and acts as a competitive antagonist. DAYVIGO was approved in the U.S. by the U.S. Food and Drug
Administration based on findings from the lemborexant clinical development program, which included two pivotal Phase 3 studies in nearly 2,000 adult
patients with insomnia. Analyses in both studies suggested DAYVIGO was not associated with rebound insomnia, and there was no evidence of
withdrawal effects following treatment discontinuation, suggesting it does not produce physical dependence in those taking it for up to one year.
DAYVIGO is the first FDA-approved insomnia medication with safety data over a 12-month treatment period and with sleep onset and sleep
maintenance efficacy data over a six-month treatment period in a pivotal clinical study.

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Lilly's Taltz® (USA) is the First IL-17AAntagonist to Receive U.S. FDA
Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis
19
Eli Lilly and Company announced the U.S. Food and Drug Administration has approved a supplemental Biologics License Application
for Taltz® injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis in patients with objective signs of
inflammation. Another first-in-class milestone for the treatment, today's approval makes Taltz the first IL-17A antagonist to be approved
by the FDA for nr-axSpA. Axial spondyloarthritis, which includes both AS and nr-axSpA, is a disease predominantly affecting the
sacroiliac joints and the spine, resulting in chronic inflammatory back pain and fatigue. It is estimated that 2.3 million people in the U.S.
have axSpA, and approximately half of those individuals live with nr-axSpA. For patients with AS, the disease is characterized by the
presence of structural damage of the sacroiliac joints that appears on an X-ray, while patients with nr-axSpAdo not have clearly detectable
structural damage radio graphically. These two patient subsets share a similar burden of disease and similar clinical features, but approved
biologic treatment options for patients with nr-axSpA are much more limited and patients are often under diagnosed.

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Kite (USA) Receives European Medicines Agency Approval for CAR T cell
Therapy Manufacturing Facility in Europe
20
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.

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Grifols (Spain) starts production of its hyperimmune immunoglobulin as a
potential passive immune therapy against COVID-19
21
Grifols , a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years
dedicated to enhancing people’s health and well-being, announced the start of production of its anti-SARS-CoV-2 hyperimmune
immunoglobulin with specific antibodies using the plasma of people who have overcome the disease. It is the first specific drug
developed to combat COVID-19. Grifols is leading the production of this potential anti-COVID-19 passive immune therapy as part
of a collaboration agreement with U.S. government entities, including the Food and Drug Administration, the National Institutes of
Health and the Biomedical Advanced Research Development Authority, among other healthcare agencies. The agreement also
encompasses the development of preclinical and clinical trials required to determine treatment efficacy. The company is also moving
forward to establish collaborations in Europe. Grifols leverages its broad expertise and experience in previous healthcare emergencies
like the Ebola outbreak to become the first company to start production of an anti-SARS-CoV-2 hyperimmune immunoglobulin.

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Illumina (USA) Receives First FDA Emergency Use Authorization for a
Sequencing-Based COVID-19 Diagnostic Test
22
Illumina, Inc. is paving the way for large-scale, next-generation sequencing-based COVID-19 testing. Today, the U.S. Food and Drug
Administration issued an Emergency Use Authorization for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro
diagnostic workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options available for labs to scale
diagnostic testing. COVIDSeq uses upper respiratory specimens, including a nasopharyngeal or oropharyngeal swab, and delivers sample
receipt to result in 24 hours using the NovaSeq™ 6000 Sequencing System. The differentiated diagnostic design includes 98 amplicons that
target the full SARS-CoV-2 genome, creating accurate detection and high sensitivity. COVIDSeq is currently available to a limited number
of early access sites, and is expected to be more broadly available this summer. The workflow accommodates up to 3,072 samples per
NovaSeq run leveraging the S4 flow cell, and includes steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation,
sequencing and report generation. The key components leveraged include the NovaSeq 6000, coupled with Illumina Tagmentation library
preparation technology, and the DRAGEN™ COVIDSeq Test Pipeline for rapid reporting.

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Johnson & Johnson (USA) Announces Acceleration of its COVID-19 Vaccine
Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July
23
Johnson & Johnson announced that through its Janssen Pharmaceutical Companies it has accelerated the initiation of the Phase 1/2a first-in-human clinical
trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to
commence in the second half of July. The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity, and
immunogenicity of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged
65 years and older. The study will take place in the U.S. and Belgium. The Company is in discussions with the National Institutes of Allergy and Infectious
Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending
outcome of Phase 1 studies and approval of regulators. As the Company progresses the clinical development of its investigational SARS-CoV-2 vaccine,
Ad26.COV2-S, recombinant, it continues to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access.
The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Johnson & Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine are enhanced by collaboration between Janssen and 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 & Human Services.

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U.S. FDAApproves New Pediatric Formulation of SIRTURO® (USA) as Part of Combination
Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
24
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration have granted approval for a new
pediatric formulation of SIRTURO®. SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients
with pulmonary multidrug-resistant tuberculosis. In the U.S., the medicine should be reserved for use when an effective treatment regimen cannot otherwise
be provided. This indication received accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in confirmatory trials. SIRTURO® should not be used for the treatment of latent TB infection,
extra-pulmonary or drug-sensitive TB, or for the treatment of infections caused by non-tuberculosis mycobacterium. The safety and efficacy of SIRTURO®
in the treatment of HIV-infected patients with MDR-TB have not been established, as clinical data are limited. Today’s decision marks the first regulatory
approval for the pediatric formulation of SIRTURO® and is a key component of Johnson & Johnson’s global pediatric research and development program
for the medicine. The new 20 mg tablet can be administered with water for patients who are able to swallow the intact tablet and taken with food. For patients
who have difficulty swallowing intact tablets, the tablet can be dispersed in water and administered. To aid with administration, the dispersed mixture in water
can be further mixed with a beverage or soft food. Alternatively, the tablet can be crushed and mixed with soft food immediately prior to use and
administered.

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LabCorp (USA) Launches New COVID-19 Clinical Trial Site to Connect Patients
with U.S. Research Trials
25
LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, announced that Covance, its drug
development business, has created COVID-19 Clinical Trial Connect in the U.S., a site designed to help people access information
about how to participate in COVID-19 research. The COVID-19 clinical trial opportunities are diverse, with sponsors recruiting
patients who currently have COVID-19, those who may be now recovered, and those who may have been exposed to corona virus.
Through the Covance COVID-19 Clinical Trial Connect site, prospective patients would be notified of studies run by Covance on
behalf of a biopharmaceutical company, as well as those listed in clinicaltrials.gov. 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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LabCorp (USA) Accelerates Adoption of Decentralized Clinical Trials, Expands
Technology Ecosystem through Alliance with Medable
26
LabCorp® , a leading global life sciences company that is deeply integrated in guiding patient care, announced that Covance, its drug
development business, is expanding its technology ecosystem to accelerate the adoption of decentralized clinical trials, often referred to as
hybrid and virtual clinical trials. Covance is expanding its decentralized trials technology ecosystem through an alliance with Medable, a
leading software provider for digital clinical trials. The Covance patient and site interface will be powered by Medable’s modular software
platform, providing immediate access to applications that will allow patients to participate in decentralized clinical trials. The platform will
also enable data and system interoperability; facilitate remote data collection and engagement between patients, sites, and clinical
investigators. In late 2019, Covance unveiled its latest solution to help transform the conduct of decentralized clinical trials. The company’s
cohesive decentralized clinical trials solution integrates unique capabilities from across Covance and LabCorp Diagnostics, redefining the
patient experience to increase participation. It provides a patient-centric ecosystem of conveniently located resources, such as LabCorp’s
U.S.-based Patient Service Centers and LabCorp at Walgreens locations, global partnerships with reputable retail pharmacies, as well as home
health phlebotomy and nursing service providers, all connected by a best-in-class technology platform.

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Pemazyre Available Exclusively at Biologics by McKesson (USA)
27
Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, will be the exclusive
specialty pharmacy provider for Pemazyre™ , Incyte’s selective fibroblast growth factor receptor inhibitor, recently approved by the U.S.
Food and Drug Administration for the treatment of adults with previously treated, unresectable locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.
Biologics specialty pharmacy is committed to and recognized for its level of customer service as well as its innovative, high-touch and
multidisciplinary patient-centric approach. Each team includes pharmacists with in-depth knowledge of therapies, experienced nurses,
and financial counselors who are familiar with various financial assistance programs and organizations that help patients. This deeply
skilled care team works together to develop an individualized care plan that address each patient’s unique clinical, financial and emotional
needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition,
the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

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FDAApproves Merck’s (USA) RECARBRIO™ for the Treatment of Adults with
Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
28
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved a
supplemental New Drug Application for RECARBRIO™ for the treatment of patients 18 years of age and older with hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia , caused by the following susceptible Gram-negative microorganisms. To
reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs,
RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. See Selected
Safety Information below. RECARBRIO met the primary and key secondary endpoints, demonstrating non-inferiority to PIP/TAZ in 28-day
all-cause mortality and clinical response at early follow-up, respectively. The RESTORE-IMI 2 study abstract was published by the 30th
European Congress of Clinical Microbiology & Infectious Diseases. RECARBRIO is also indicated in adults who have limited or no
alternative treatment options for complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections
caused by susceptible Gram-negative bacteria, as described below. RECARBRIO is administered via intravenous injection.

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LYNPARZA® (USA) Approved by FDA for Treatment of HRR Gene-Mutated Metastatic Castration-Resistant
Prostate Cancer That Has Progressed Following Prior Treatment with Enzalutamide or Abiraterone
29
AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration
has approved LYNPARZA for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous
recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with
enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. The
approval was based on positive results from Phase 3 PROfound trial and published in TheNew England Journal of Medicineon April 28,
2020. Prostate cancer is the second-most common cancer in men, and despite an increase in the number of available therapies for men
with mCRPC, five-year survival remains low. HRR gene mutations occur in approximately 20-30% of patients with mCRPC.
LYNPARZA is currently under regulatory review in the European Union and other jurisdictions as a treatment for men with HRR
gene-mutated mCRPC. AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer, including the ongoing Phase
3 PROpel trial evaluating LYNPARZA as a first-line therapy in combination with abiraterone acetate for patients with mCRPC vs.
abiraterone acetate alone.

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FDAApproves DUPIXENT® (USA) As First Biologic Medicine for Children
Aged 6 To 11 Years with Moderate-To-Severe Atopic Dermatitis
30
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has approved Dupixent® for
children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical
prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this
population. The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent
potentially significant improvements in efficacy or safety in treating serious conditions. The FDA previously granted
Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of
age not well controlled on topical prescription medications. The Breakthrough Therapy designation was created to expedite the
development and review of drugs developed for serious or life-threatening conditions.

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Roche’s (Switzerland) Elecsys IL-6 test receives FDA Emergency Use Authorization
to help in identifying patients at high risk of severe inflammatory response
31
Roche announced that the U.S. Food and Drug Administration have issued an Emergency Use Authorization for the Elecsys® IL-6 test. This
test measures levels of the biomarker interleukin 6 and can be used to help identify patients with confirmed COVID-19 disease who could be
at high risk of intubation with mechanical ventilation. Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas e®
analyzers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes,
with a test throughput of up to 300 tests/hour depending on the analyzer. The IL-6 immunoassay is an in vitro diagnostic test for the
quantitative determination of IL-6 (interleukin-6) in human serum or plasma. This assay is used in countries accepting CE-mark to aid in the
management of critically ill patients, as an early indicator for acute inflammation. Under the Emergency Use Authorization in the US, this
assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the
risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. IL-6 is released
by immune cells, once they are activated by virus, bacteria or other immune cells.

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FDA approves Roche’s (Switzerland) Tecentriq in combination with Avastin for
people with the most common form of liver cancer
32
Roche announced that the US Food and Drug Administration has approved Tecentriq® in combination with Avastin® for the treatment
of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. The review of this
application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review
of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow
patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory
submissions.1 Simultaneous applications were submitted to regulators in the United States, Australia, Canada and Singapore under
Project Orbis. Additionally, the FDA rapidly reviewed and approved the application under its Real-Time Oncology Review (RTOR) pilot
programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early
as possible. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies,
across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies
evaluating Tecentriq both alone and in combination with other medicines.

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FDA approves Roche’s (Switzerland) Tecentriq as a first-line monotherapy for
certain people with metastatic non-small cell lung cancer
33
Roche announced that the US Food and Drug Administration has approved Tecentriq® as a first-line treatment for adults with
metastatic non-small cell lung cance whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells or
PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumour area , as determined by an FDA-approved test, with no EGFR
or ALK genomic tumour aberrations. This approval is based on an interim analysis from the Phase III IMpower110 study,
which showed that Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy in people
with high PD-L1 expression (TC3/IC3-wild-type. Safety for Tecentriq appeared to be consistent with its known safety profile,
and no new safety signals were identified. Grade 3–4 treatment-related adverse events were reported in 12.9% of people
receiving Tecentriq compared with 44.1% of people receiving chemotherapy.

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Thermo Fisher (USA) Extends NanoDrop One/OneC Spectrophotometer to
FDA-Regulated Companies
34
Thermo Fisher Scientific announced its Thermo Scientific NanoDrop PC Control software + Security Suite for NanoDrop One/OneC can be
used in compliance with U.S. Food and Drug Administration Title 21 CFR Part 11, which governs the security of electronic records and
signatures to ensure they are trustworthy substitutes for paper records and handwritten signatures. The NanoDrop One PC Control + Security
Suite Software meets these data integrity standards by providing administrative control over user accounts, an audit trail for user integrity, and
the compliant use of electronic signatures. With this release, the Thermo Scientific NanoDrop One/OneC Microvolume UV-Vis
spectrophotometers can be used in a lab that complies with Title 21 CFR Part 11. Built with the novel Thermo Scientific Acclaro Sample
Intelligence technology, NanoDrop One/OneC instruments help researchers identify contaminants in nucleic acid and protein samples and
obtain corrected concentration results so they can make educated decisions about sample quality. A simple, automated workflow yields
measurements in just eight seconds, sending users alerts when a contaminant is present. With the addition of software that includes Title 21
CFR Part 11 compliant features; regulated labs can now meet FDA regulations while obtaining the accurate quantification and purity
information they need to ensure downstream application success.

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Thermo Fisher (USA) Scientific to Showcase New Mass Spectrometry Systems
and Software during Virtual ASMS Event
35
Thermo Fisher Scientific Inc., the world leader in serving science, will provide online programming and virtual exhibits to introduce scientists to
a number of new products that build on its leading Orbitrap platform and expand research applications. The company will showcase its newest
instruments, software and workflow solutions during a company-hosted virtual event, vLC-MS.com, and at the American Society for Mass
Spectrometry Reboot Program. The new Thermo Scientific Orbitrap Exploris 240 mass spectrometer expands the proven Orbitrap Exploris
platform and is designed to give scientists working in proteomics, metabolomics, biopharmaceutical characterization and small-molecules, the
analytical performance required for research and high-throughput analyses. The new system will advance discovery and identification with
increased accuracy for confident scale-up, while providing operational simplicity and streamlining time-to-result. In addition, the new Thermo
Scientific Orbitrap Exploris 120 mass spectrometer delivers demonstrated qualitative and quantitative capabilities synonymous with Orbitrap
high-resolution accurate-mass spectrometry, with internal calibration that assures consistent data quality and decision making. The new instrument
is designed to deliver proven measurement capabilities in a system developed for increased productivity. These newest systems extend the Thermo
Scientific Orbitrap Exploris portfolio of HRAM systems, which were introduced in 2019 with the release of the new-generation Thermo Scientific
Orbitrap Exploris 480 mass spectrometer.

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Vertex (USA) Announces European Commission Approval for KALYDECO® for Children and Adolescents
with Cystic Fibrosis between the Ages of 6 Months and 18 Years with the R117H Mutation in the CFTR Gene
36
Vertex Pharmaceuticals Incorporated announced that the European Commission has granted approval of the label extension for
KALYDECO® to include the treatment of children and adolescents with cystic fibrosis , ages 6 months and older and weighing at
least 5 kg, who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene – the most common
residual function mutation underlying CF. Now approved, KALYDECO® will be immediately available to additional eligible
patients in Germany and shortly in countries where respective long-term reimbursement agreements have been previously secured.
Vertex will work closely with all other relevant government authorities to secure access for eligible patients as quickly as possible. In
Europe, KALYDECO® is already approved for the treatment of people with CF ages 18 and older with the R117H mutation, and in
infants ages 6 months and older weighing at least 5 kg who have one of the following mutations in the CFTR gene: G551D, G1244E,
G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

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Align Technology’s (USA) Itero® Element 5d Imaging System Awarded “Best New
Technology Solution for Dentistry” In 2020 Medtech Breakthrough Awards
37
MedTech Breakthrough, an independent market intelligence organization that recognizes the top technology product
companies in the global health and medical technology market, announced today that it has selected Align Technology, Inc.
as the winner of the “Best New Technology Solution for Dentistry” award for its iTero Element® 5D Imaging System in its
fourth annual MedTech Breakthrough Awards program. The iTero Element 5D, the latest innovation in the iTero product
portfolio, is the first integrated dental imaging system that simultaneously records 3D intra-oral optical impressions, 2D color
images, and Near Infrared images. With the iTero Element 5D, full arch scans can be completed in as little as 60 seconds.
iTero Element 5D’s NIRI technology scans the structure of a tooth in real time, without harmful radiation, acting as a digital
aid for detection of interproximal caries. Through iTero Element 5D’s visualization tools, patients can see and better
understand their current dental health issues, their treatment plan options, and simulated outcomes directly on-screen at the
doctor’s office, enabling education and compliance during treatment, and an overall better patient experience.
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OPTI Medical Systems (USA) Receives CE Mark for Its OPTI SARS-CoV-2 RNA
PCR Test Kit for Detection of the Virus Causing COVID-19
38
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. announced that it has received the CE mark
certification in the European Union for its OPTI® SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2,
the virus that causes COVID-19. This announcement follows earlier validation of the test by the Institute Pasteur of France as
well as Emergency Use Authorization by the United States Food and Drug Administration. Additionally, the FDA has granted
EUA for the new OPTI DNA/RNA Magnetic Bead Kit for nucleic acid extraction from respiratory samples to be used with
the OPTI SARS-CoV-2 RT-PCR test kit, which enables OPTI Medical Systems to provide laboratories with a complete OPTI
Medical Systems-manufactured workflow solution for COVID-19 testing. The OPTI SARS-CoV-2 RT-PCR test kit uses
real-time reverse transcription polymerase chain reaction technology and is designed to provide results in approximately
2–3.5 hours.
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REGENERON (USA) Recognized As Healthcare Sector Leader on "The Civic 50"
List of the Most Community-Minded Companies in the United States
39
Regeneron Pharmaceuticals, Inc. announced that it has been named to The Civic 50 for the fourth consecutive year and honored for the
first time as the sector leader for healthcare. The Civic 50 is an initiative of Points of Light, the world's largest organization dedicated to
volunteer service, and recognizes the most community-minded companies in the United States. The Civic 50 sets 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 with 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. This
honor recognizes Regeneron's integrated approach to corporate responsibility and creating high-impact community engagement
programs and partnerships. In 2019, Regeneron invested $19.2 million in non-profit organizations to foster future generations of scientific
leaders and support the communities where it operates. In addition to its 10-year, $100 million commitment to the Society for Science and
the Public to support the Regeneron Science Talent Search, Regeneron became the new title sponsor of the International Science and
Engineering Fair, the world's largest pre-college science and engineering competition.
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AmerisourceBergen (USA) Selected by Deciphera Pharmaceuticals to Support
QINLOCK™
40
AmerisourceBergen, a global healthcare solutions leader, announced that it has been selected by Deciphera Pharmaceuticals to support
QINLOCK. AmerisourceBergen is providing a unified commercialization approach for QINLOCK which was approved by the U.S. Food and
Drug Administration. QINLOCK is an orally administered kinase switch control inhibitor approved for the treatment of adult patients with
advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib. In the United
States, there are an estimated 4,000 to 6,000 cases of GIST, a rare form of cancer, diagnosed annually. The gastrointestinal cancer is
characterized by disease-related symptoms, including vague abdominal pain, early feelings of fullness, vomiting and fatigue due to anemia.
About 40-70% of GISTs are found in the stomach, 20-40% in the small intestine, 5-15% in the colon and rectum, and in rare cases, the
esophagus. QINLOCK is a tyrosine kinase switch control inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases,
where genetic mutations or alterations in these kinases play a crucial role in the biology of these tumors leading to drug-resistance and disease
progression.
Description

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Centene (USA) Subsidiary WellCare of Kentucky Selected to Continue Serving
Medicaid Managed Care Program in the Commonwealth
41
Centene Corporation announced its subsidiary WellCare of Kentucky has been selected by the state of Kentucky to continue serving the
commonwealth's Medicaid managed care program statewide. WellCare has provided Medicaid managed care services for Kentuckians since
2011, and under the new contract, will continue to coordinate medical, behavioral and dental health for eligible Medicaid recipients in the
Temporary Assistance for Needy Families; State Children's Health Insurance Program; Medicaid expansion; and Aged, Blind and Disabled
programs. 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.
Centene offers affordable and high-quality products to nearly 1 in 15 individuals across the nation, including Medicaid and Medicare members
(including Medicare Prescription Drug Plans) as well as individuals and families served by the Health Insurance Marketplace, the TRICARE
program, and individuals in correctional facilities.
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Fresenius (Germany) Kabi enters marketing agreement for biosimilar product
42
Fresenius Kabi and the pharmaceutical company medac have agreed to cooperate in Germany in the area of treatments for
rheumatic illnesses. Medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO® as an additional
therapy option to the rheumatologists and dermatologists they work with. This biosimilar, developed by Fresenius Kabi and
launched last year in Europe, is used to treat autoimmune illnesses such as arthritis and psoriasis. medac is a leading provider
of methotrexate for the parenteral treatment of patients with chronic inflammatory diseases. Since affected patients are often
treated with a combination of methotrexate and adalimumab, the partnership between Fresenius Kabi and medac will offer
patients and doctors new benefits and synergies in therapy offerings as well as consulting.
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QINLOCK, FDAApproved for Treatment of Gastrointestinal Stromal Tumors,
Available at Biologics by McKesson (USA)
43
Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, was selected by Deciphera Pharmaceuticals as
a specialty pharmacy provider for QINLOCKTM for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior
treatment with three or more kinase inhibitors, including imatinib. QINLOCK, approved by the FDA, is for patients who have a significant unmet medical
need despite currently available therapies. Because more than 90% of individual metastatic KIT-driven GIST patients experience multiple mutations that
cause their disease to progress, this disease is often resistant to existing therapies as they fail to inhibit all known mutations. QINLOCK was designed to
inhibit the complete spectrum of known mutations in KIT and platelet-derived growth factor receptor A. Biologics specialty pharmacy is committed to and
recognized for its quality level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes
pharmacists with in-depth knowledge of therapies, experienced nurses and financial counselors who are familiar with various financial assistance programs
and organizations that help patients. This deeply-skilled care team works together to develop an individualized care plan that address each patient’s unique
clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes.
In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.
Description

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RETEVMO, FDA-Approved for Treatment of RET-driven Lung and Thyroid
Cancers, Available at Biologics by McKesson (USA)
44
Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, has been selected by Eli Lilly and Company as a specialty
pharmacy provider for RETEVMOTM, the first drug approved by the U.S. Food and Drug Administration specifically for patients with advanced RET-driven non-small
cell lung cancer and thyroid cancers. RETEVMO, approved by the FDA on May 8, 2020, is indicated for the treatment of adults with metastatic RET fusion-positive
non-small cell lung cancer as well as adults and children 12 years and older with either advanced or metastatic RET-mutant medullary thyroid cancer who require
systemic therapy or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive
iodine is appropriate). Crossing the blood-brain barrier, this drug shrinks tumors in parts of the central nervous system, including the brain. This is important to RET
fusion-positive NSCLC patients because up to 50% can have tumors that metastasize to the brain. Biologics specialty pharmacy is committed to and recognized for its
quality level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes pharmacists with in-depth
knowledge of therapies, experienced nurses, and financial counselors who are familiar with various financial assistance programs and organizations that help patients.
This deeply-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and
streamline communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with
payers to ensure patients can access the specialty medications they need.
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Partner Ecosystem

Partner Ecosystem Updates
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AbbVie (USA) and Genmab Announce Broad Oncology Collaboration
45
AbbVie and Genmab A/S announced that AbbVie and Genmab have signed a broad collaboration agreement to jointly develop and commercialize
three of Genmab's early-stage investigational bispecific antibody product candidates and enter into discovery research collaboration for future
differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab's next-generation bispecific antibody programs,
epcoritamab, DuoHexaBody®-CD37 and DuoBody-CD3x5T4. The collaboration combines Genmab's world-class discovery and development
engine and next-generation bispecific antibody therapeutic candidates with AbbVie's deep clinical expertise, innovative antibody-drug conjugate
(ADC) platform and global commercial leadership in hematological cancers. The discovery research collaboration will combine proprietary
antibodies from both companies along with Genmab's DuoBody technology and AbbVie's payload and ADC technology to select and develop up
to four additional differentiated next-generation antibody-based product candidates, potentially across both solid tumors and hematological
malignancies. Genmab's DuoBody-CD3 technology engages and directs cytotoxic T cells selectively to tumors to elicit an immune response
towards malignant tumor cells. AbbVie's ADC technology allows the delivery of a therapeutic toxin directly to cancer cells while sparing normal,
healthy cells, providing for a more targeted, less toxic treatment approach.
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AbbVie(USA), Harbour BioMed, Utrecht University and Erasmus Medical Center Announce
Collaboration to Develop Monoclonal Antibody Therapy to Prevent and Treat COVID-19
46
AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center announced they have entered into a
collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19, the pandemic respiratory disease
caused by the SARS-CoV-2 virus. The focus of the collaboration is on advancing the fully human, neutralizing
antibody 47D11 discovered by UU, EMC and HBM and recently reported in Nature Communications. This antibody
targets the conserved domain of the spike protein of SARS-CoV-2. Under the terms of the collaboration, AbbVie will
support UU, EMC and HBM through the preclinical activities, while simultaneously undertaking preparations for later
stage preclinical and clinical development work. AbbVie will receive an option to exclusively license the antibody
from the three parties for therapeutic clinical development and commercialization worldwide.
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AbbVie (USA) and Jacobio Announce Strategic Collaboration to Advance SHP2
Inhibitors
47
AbbVie , a research-based global biopharmaceutical company, and Jacobio Pharmaceuticals, a clinical-stage pharmaceutical company, announced
a global, strategic collaboration to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. SHP2 is an
important protein mediator of cellular signaling through RAS/MAP kinase pathway. Many tumors have genetic mutations, driving abnormal
cancer cell growth which relies on SHP2 activity. SHP2 also plays a key role to control cytokine production and immune cell response. Therefore,
inhibition of SHP2 is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate
anti-tumor activities. Jacobio's early clinical stage SHP2 assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit
SHP2 activity. Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to
conduct early global clinical trials of JAB-3068 and JAB-3312 with AbbVie covering R&D expenses. Upon completion, AbbVie will assume
global development and commercialization responsibilities. Jacobio has an option, exercisable before the initiation of registration trials, to
exclusively develop and commercialize the SHP2 program in mainland China, Hong Kong, and Macau. Financial terms were not disclosed and
the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Description

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AbbVie (USA) and Genmab Announce Broad Oncology Collaboration
48
AbbVie and Genmab announced that AbbVie and Genmab have signed a broad collaboration agreement to jointly develop and commercialize three
of Genmab's early-stage investigational bispecific antibody product candidates and enter into discovery research collaboration for future
differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab's next-generation bispecific antibody programs,
epcoritamab, DuoHexaBody®-CD37 and DuoBody-CD3x5T4. The collaboration combines Genmab's world-class discovery and development
engine and next-generation bispecific antibody therapeutic candidates with AbbVie's deep clinical expertise, innovative antibody-drug conjugate
platform and global commercial leadership in hematological cancers. The discovery research collaboration will combine proprietary antibodies
from both companies along with Genmab's DuoBody technology and AbbVie's payload and ADC technology to select and develop up to four
additional differentiated next-generation antibody-based product candidates, potentially across both solid tumors and hematological malignancies.
Genmab's DuoBody-CD3 technology engages and directs cytotoxic T cells selectively to tumors to elicit an immune response towards malignant
tumor cells. AbbVie's ADC technology allows the delivery of a therapeutic toxin directly to cancer cells while sparing normal, healthy cells,
providing for a more targeted, less toxic treatment approach.
Description

IT Shades
Engage & Enable
Anthem (USA), Inc leads collaboration to develop tools to help public official
and businesses make informed Decisions related to COVID-19
49
Anthem, Inc. introduced a suite of digital tools that provide in-depth, trusted, and aggregated information for multiple stakeholders to use in making informed, data-driven decisions during the COVID-19
pandemic. Led by Anthem, Inc.’s new C19 Explorer and C19 Navigator, these decision support tools are also designed to assist public health officials and business leaders as they plan for re-opening and
return-to-workplace.
The tools include:
• C19 Explorer: Intended for government officials, healthcare leaders and community leaders, C19 Explorer provides intuitive, interactive dashboards on the COVID-19 situation – both current and predictive
– regarding areas such as infection rate and community risk scores
• C19 Navigator: C19 Navigator is designed for Anthem employer customers, including states and other governmental entities, for their plan populations, to provide clinical insight and predictions, as these
organizations consider their next steps on how to reopen
• Sydney Care: Digital-first consumer application that delivers personalized engagement and real-time access to health information, telehealth services, and AI-driven symptom checker.
• Safer Entry to Workplace: Biometric Passport includes the ability to evaluate employees’ possible COVID-19 symptoms through daily attestations, empowering employers to use this information for strategic
planning.
• Family Caregiver Support: Through the ianacare free mobile app, consumers can mobilize personal social circles of friends, family, coworkers and neighbors to coordinate practical help with everyday needs
such as dropping off groceries, picking up medications from the pharmacy, virtual check-ins and emotional connection.
• Mental Health Resources: PsychHub is a COVID-19 mental health resource hub that provides a range of resources designed to help people, their families, and care providers cope with pandemic-related stress
brought on by social isolation, job loss, and other challenges.
• Social Care Network: Anthem has partnered with Aunt Bertha, a leading social care network, which helps connect individuals and families to free and reduced-cost social services in their communities.
Description

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Astellas(Japan) , City of Yokohama, and Yokohama City University Developed Science-Based
Exercise Programs through Industry-Government-Academia Collaboration
50
Astellas Pharma Inc. developed science-based exercise programs in cooperation with the City of Yokohama, Kanagawa Prefecture and
Yokohama City University. Exercise therapy is reported to be beneficial to patients with type 2 diabetes, and the Japanese Clinical
Practice Guidelines for Diabetes 2019 issued by the Japan Diabetes Society indicates that “exercise therapy consisting of aerobic
exercise, resistance exercise, or combination of the two improves blood glucose control and risk factors for cardiovascular disease in
patients with type 2 diabetes.” Therefore, there was a need for the development of scientific evidence to support the specific instruction
of effective exercise therapies by way of detailed exercise programs and implementation methods for diabetes patients or how to
implement them. Astellas has been aiming to develop science-based exercise programs for exercise therapies for patients with type 2
diabetes by combining Astellas’ strength cultivated through its ethical pharmaceutical business practices, and technology and knowledge
from different fields through industry-government-academia collaboration with City of Yokohama and YCU. We have designed an
exercise program combining aerobic exercise with resistance exercise and confirmed the clinical utility of this exercise program in
improving blood glucose control in a medical and health research conducted in Japan.
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AstraZeneca (UK) to discover and develop novel therapies targeting RNA-modifying
proteins in oncology collaboration with Accent Therapeutics
51
AstraZeneca will collaborate with Accent Therapeutics to discover, develop and commercialize transformative therapeutics targeting
RNA-modifying proteins for the treatment of cancer. This collaboration focuses on targeting RMPs, proteins that control many
aspects of RNA biology and represents a new approach for addressing the process disruptions that can lead to cancer and can cause
resistance to medicines. It combines AstraZeneca’s industry leading expertise bringing forward novel oncology medicines with
Accent’s expertise as a leader in the biology, target identification and drug discovery of RMP-targeting therapies. Under the terms of
the collaboration agreement, Accent will be responsible for research and development activities for a nominated preclinical
programme through to the end of Phase I clinical trials. Following completion of Phase I, AstraZeneca will lead development and
commercialization activities for the programme, with Accent having the option to jointly develop and commercialize with
AstraZeneca in the US. AstraZeneca will also have the exclusive option to license worldwide rights to two further preclinical
discovery programmes, for which Accent will conduct certain preclinical activities.
Description

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AstraZeneca (UK) collaborates with ArcherDX to use personalized cancer assays
to detect minimal residual disease in lung cancer trials
52
AstraZeneca will collaborate with ArcherDX, a genomic analysis company focused on precision oncology, to use personalized cancer
monitoring to detect minimal residual disease in patients with early-stage non-small cell lung cancer. ArcherDX’s personalized assay will be
used in AstraZeneca’s recently launched Phase III MERMAID-1 trial to evaluate the effect of adjuvant treatment with Imfinzi plus
chemotherapy versus chemotherapy alone on disease-free survival. The trial is in patients with completely resected, Stage II and III NSCLC
who show evidence of MRD suggesting a high risk of relapse. MRD describes a very small number of otherwise undetectable cancer cells
that shed circulating tumor DNA in the blood. Monitoring for the presence of MRD using ctDNA may provide valuable information on how
well a treatment is working, inform prognosis, and detect if a patient’s cancer has returned. Ultimately, MRD detection may enable physicians
to intervene earlier and tailor the best treatment options for individual cancer patients. Under the terms of the agreement, ArcherDX will
perform whole exome sequencing of NSCLC patient samples and generate highly sensitive, personalized ctDNA assays to test for MRD that
remains after a patient’s successful surgery. The ongoing development of these assays is informed by the TRACERx study, funded by Cancer
Research UK and led by UCL and the Francis Crick Institute.
Description

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Centene(USA), NMQF Partner to Study Impact of COVID-19 on Racial Minorities
and Underserved Communities
53
Centene Corporation, a leading multi-national healthcare enterprise, and the National Minority Quality Forum, an independent
research and educational organization dedicated to ensuring high-risk racial and ethnic populations receive optimal healthcare,
announced today a research partnership for the "Minority and Rural Health Corona virus Study" to assess the impact of
COVID-19 on racial minorities and underserved communities across the country. While the effects of the pandemic are still
emerging, current data suggests certain populations are more vulnerable than others. In addition to those age 65 and older, recent
data suggests the virus is having a disproportionate impact on communities of color. MRCS is a prospective longitudinal study of
the risk factors associated with the disproportionate impact that corona virus is having on racial minorities and rural communities.
Beginning in June, Centene, NMQF, and a range of other public and private healthcare entities including Quest Diagnostics, will
conduct COVID-19 PCR testing and antibody testing at federally qualified health centers in five states across the country. Quest
will also contribute its Health Trends data to support the research.
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Cigna (USA) and Multicare Reach Multi-Year Agreement to Keep Quality Care
Affordable
54
Cigna and MultiCare Health System have reached a multi-year agreement that ensures access to quality care for Cigna customers at predictable,
affordable rates. It covers MultiCare's hospitals and facilities, including Tacoma General Hospital. The agreement applies to multiple lines of business,
including Cigna's high-performing LocalPlus network, and continues Cigna's value-based Collaborative Care program that incentivizes MultiCare for
meeting certain quality and affordability targets. By establishing a framework for information sharing and joint accountability, Cigna Collaborative
Care aims to advance care quality while driving down medical costs for employers and individuals. 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. All products and services
are provided exclusively by or through operating subsidiaries of Cigna Corporation, including Cigna Health and Life Insurance Company, Cigna Life
Insurance Company of New York, Connecticut General Life Insurance Company, Express Scripts companies or their affiliates, and Life Insurance
Company of North America. Such products and services include an integrated suite of health services, such as medical, dental, behavioral health,
pharmacy, vision, supplemental benefits, and other related products including group life, accident and disability insurance.
Description

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The University of Tokyo, RIKEN, Nichi-Iko and Daiichi Sankyo (Japan) Reach Basic Agreement on Collaborative
R&D on Nafamostat Inhalation Formulation for Treatment of Novel Corona Virus Infection
55
The University of Tokyo, RIKEN, Nichi-Iko Pharmaceutical Co., Ltd. and Daiichi Sankyo Company, Limited have reached a basic
agreement on collaborative R&D on a Nafamostat inhalation formulation for the treatment of novel corona virus infection. The
University of Tokyo and others discovered that by preventing this fusion, Nafamostat could efficiently inhibit the viral entry process.
Nafamostat is an injectable that has been prescribed mainly as a treatment for acute pancreatitis and disseminated intravascular
coagulation for many years in Japan and adequate safety-related clinical data has been accumulated. RIKEN has established the program
for drug discovery and medical technology platforms in order to optimize the medical seeds generated from basic research at RIKEN and
at universities for use in the drug discovery process at pharmaceutical companies, and in clinical practice, as a bridge to companies and
medical institutions. In this case, RIKEN will also support this collaborative R&D using RIKEN's multidisciplinary advanced
technologies. Daiichi Sankyo will carry out R&D on the Nafamostat inhalation formulation using technology gained in the development
of its anti-influenza virus agent, Inavir®. Non-clinical studies are scheduled to begin in July this year and after consultation with
authorities with the aim of proceeding to clinical studies by March 2021.
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Daiichi Sankyo (Japan) Announces Clinical Research Collaboration to Evaluate DS-1062
in Combination with KEYTRUDA® in Metastatic Non-Small Cell Lung Cancer
56
Daiichi Sankyo Company, Limited announced that it has entered into a clinical trial collaboration agreement with a subsidiary of Merck &
Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the United States and Canada, to evaluate the combination of DS-1062, a
TROP2 directed DXd antibody drug conjugate, and KEYTRUDA® in patients with previously-treated advanced or metastatic non-small cell
lung cancer without actionable genomic alterations. There are no TROP2 directed therapies and no ADCs currently approved for treatment of
NSCLC, which frequently over expresses the TROP2 protein. Under the terms of the agreement, Daiichi Sankyo will conduct a multicenter,
two-part, open-label, non-randomized, phase 1b study of DS-1062 in combination with KEYTRUDA in patients with advanced or metastatic
NSCLC without actionable genomic alterations and previously treated with platinum-based chemotherapy with or without immunotherapy.
Patients need to have been previously treated with one regimen of a PD-1/PD-L1 directed immunotherapy, except if patients have a PD-L1
proportion score of <1%. The first part of the study will evaluate the safety and tolerability of increasing doses of DS-1062 with a fixed dose
of KEYTRUDAto determine the maximum tolerated dose and/or recommended dose for expansion. The second part of the study will evaluate
the safety and tolerability of DS-1062 at the RDE in combination with KEYTRUDA.
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Lilly(USA) Partners with Indianapolis Recorder Newspaper, Radio One and WISH-TV
for a Day of Solidarity Virtual Event
57
Eli Lilly and Company, Indianapolis Recorder Newspaper, Radio One and WISH-TV invite people and organizations to come together to acknowledge the
trauma of racial injustice, understand its many forms, and create a call to action for lasting change. As Indianapolis' oldest African American newspaper, the
largest minority-owned television station, the largest urban radio station and one of Indianapolis's major employers for more than 144 years, these partners
are using their platforms to speak up, speak out, and work toward solutions to the racism and inequalities that African Americans and other minorities have
experienced for far too long in Indiana and across the nation.
In addition to participating in the virtual event on Saturday, people can show their solidarity by:
• Wearing black to symbolize the dark time we're living in – with a pandemic that is affecting minorities disproportionately and recent acts of deadly violence
against African Americans.
• Taking time to read, think and reflect on the kind of community you want – and what you can learn or change to help us get there.
• Reaching out to someone different from you to learn about each other's journey through life: how are you similar, and how have your experiences been
different?
• Speaking out. Promote the Indy Day of Solidarity by sharing Lilly's social media posts on your social media accounts.
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Gilead Sciences (USA) and Arcus Biosciences Establish 10-year Partnership to Co-de-
velop and Co-commercialize Next-generation Cancer Immunotherapies
58
Gilead Sciences, Inc. and Arcus Biosciences, Inc., an oncology-focused biopharmaceutical company working to create best-in-class cancer
therapeutics, announced that the companies have entered into a 10-year partnership to co-develop and co-commercialize current and future therapeutic
product candidates in Arcus’s pipeline. The agreement will also provide ongoing funding to support Arcus’s research and development programs. Arcus
is building an extensive and diverse portfolio of investigational products that target important mechanisms involved in tumor evasion of the immune
system, as well as developing drug candidates that target cell-intrinsic pathways important for cancer growth and metastasis. In addition to small
molecule products, Arcus is also advancing antibody products that target immune checkpoint receptors, including PD-1 and TIGIT. Arcus currently has
a clinical-stage pipeline of four immuno-oncology programs, as well as an active oncology discovery pipeline with six preclinical compounds that target
critical biological pathways. A core component of Arcus’s strategy is the development of intra-portfolio combinations that include small-molecule and
antibody product candidates. Arcus has 10 ongoing clinical studies of molecules in its portfolio, including a randomized Phase 2 study in first-line
non-small cell lung cancer evaluating combinations of three Arcus product candidates: AB154, an investigational anti-TIGIT monoclonal antibody;
AB928, an investigational A2aR/A2bR antagonist; and zimberelimab , an investigational anti-PD-1 monoclonal antibody.
Description

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