I-Bytes Healthcare Industry

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I-Bytes
Healthcare
January Edition 2020
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Table of Contents
1. Financial, M & A Updates..................................................................................................................................1
2. Solution Updates................................................................................................................................................24
3. Rewards and Recognition Updates..................................................................................................................60
4. Customer Success Updates................................................................................................................................63
5. Partnership Ecosystem Updates.......................................................................................................................67
6. Miscellaneous Updates......................................................................................................................................86

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Financial, M & A
Updates Healthcare Industry

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Financial, M&A Updates
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Astellas (Japan) Commences Tender Offer to Acquire All Outstanding
Shares of Audentes
Astellas Pharma Inc. announced that it has commenced, through its indirect, wholly-owned subsidiary Asilomar
Acquisition Corp., a tender offer for all of the issued and outstanding shares of common stock of Audentes
Therapeutics, Inc. for a price of US$60.00 per share, net to the seller in cash, on December 16, 2019, New York
City time. The Tender Offer is scheduled to expire at 12:00 midnight, New York City time, at the end of the day on
January 14, 2020, unless extended or earlier terminated. The Tender Offer was commenced pursuant to the
definitive agreement dated December 2, 2019, by and among Astellas, Asilomar and Audentes, and promptly upon
successful completion of the Tender Offer, Asilomar will be merged into Audentes, with Audentes surviving the
merger as a subsidiary of Astellas.
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Astellas (Japan) Strengthens Immuno-oncology Pipeline with Acquisition
of Xyphos Biosciences, Inc.
Astellas Pharma Inc. and Xyphos Biosciences, Inc. announced that Astellas has acquired Xyphos.
With the acquisition Astellas will gain Xyphos’novel and proprietary ACCEL technology platform, as
well as industry-leading immuno-oncology talent, to develop new and potentially better ways to
mobilize, target and control immune cells to find, modulate and destroy targeted cells throughout the
body.Xyphos has developed a flexible and versatile synthetic biology platform to direct cells of the
immune system to target single or multiple tumor antigens while controlling the immune cell
proliferation and endurance. Xyphos’s proprietary molecules can be delivered to natural immune cells
or to engineered Chimeric Antigen Receptor (CAR) cells to generate immunotherapies for oncology.
Xyphos’patented CAR technology is based on an engineered modification to a natural human receptor
named NKG2D. NKG2D exists on natural killer (NK) cells and some T-cells. The designed
modification of NKG2D renders it inert, that is, unable to bind to any of its natural ligands, which
occur on stressed cells. Through further protein engineering, several natural ligands of NKG2D have
been modified to bind exclusively to the otherwise inert NKG2D receptor. Various functional
molecules (for example, antibodies that recognize specific tumor antigens) are attached to the
modified ligand. The ligand-directed functional molecules then bind exclusively to immune cells
expressing the inert CAR on their surface – the proprietary convertibleCAR®-cells. The CAR-cells
can be directed by the ligand-bound antibody to seek, become activated and attacks a targeted cancer
cell. Xyphos’ first convertibleCAR-T cell product candidate is in preclinical development and
scheduled to be tested in a first-in-human clinical study in 2021.
Executive Commentary
“At Astellas, immuno-oncology is a Primary Focus of our research and development strategy, and
we are working on the development of next-generation cancer immuno-therapy using new
modalities/technologies,” said President and CEO, Astellas. “The innovative technology in
development at Xyphos fits perfectly in advancing our immuno-oncology strategy to create and
deliver value for patients. Combining this technology with our capabilities in cell therapy that we
have been working on so far, we can create next-generation high-function cells and maximize the
value of our technology. We look forward to working with Xyphos’ superb team to advance and
expand their clinical development programs to bring their novel therapeutics to patients.”
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AstraZeneca (UK) Agreement with Cheplapharm for rights to Seroquel
and Seroquel XR in Europe and Russia completed
AstraZeneca has completed an agreement to divest its commercial rights to Seroquel and Seroquel XR in Europe and Russia to
CheplapharmArzneimittel GmbH.Under the terms of the agreement, AstraZeneca has received a payment of $178m from Cheplapharm. The
Company may also receive future sales-contingent payments of up to $61m. The upfront payment will be reported in AstraZeneca’s financial
statements within Other Operating Income & Expense in the fourth quarter of 2019.Pursuant to Listing Rule 10.4.1R (notification of class 2
transactions), the gross book value of assets subject to the divestment as at 31 December 2018 was nil. In the year to 31 December 2018, the
aggregate profit before tax attributable to Seroquel and Seroquel XR in the relevant territories was $86m. The consideration was paid in cash
and the proceeds will be used for general corporate purposes.Seroquel and Seroquel XR are atypical anti-psychotic medicines with
antidepressant properties. The main indications for Seroquel are the treatment of schizophrenia and bipolar disorder. Seroquel XR is also
approved in some markets for major depressive disorder and generalised anxiety disorder.AstraZeneca previously divested the rights to
Seroquel and Seroquel XR in the UK, Japan and other major international markets. AstraZeneca also agreed to divest the rights to the
medicines in the US and Canada to Cheplapharm earlier in 2019.
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AstraZeneca (UK) divests rights to Arimidex and Casodex in Europe and
certain additional countries
AstraZeneca announced that it has agreed to sell the commercial rights to Arimidex and
Casodex in a number of European, African and other countries1 to Juvisé
Pharmaceuticals.The medicines, used primarily to treat breast and prostate cancers, have lost
their compound patent protection in these countries. AstraZeneca already divested the rights
to both Arimidex and Casodex in the US in 2017.As there were no closing conditions to the
divestment, the agreement became effective upon signing. Juvisé Pharmaceuticals has made
an upfront payment of $181m to AstraZeneca and may also make future sales-contingent
payments of up to $17m. Income arising from the upfront payment will be reported in
AstraZeneca’s financial statements in the fourth quarter of 2019. Income from the upfront
and any future payments will be reported within Other Operating Income & Expense. In
2018, Arimidex had sales of $37m in the countries covered by this agreement, while Casodex
had sales of $24m. The divestment does not change the Company’s financial guidance for
2019.Arimidex (anastrozole) is an aromatase inhibitor, indicated primarily for the adjuvant
treatment of postmenopausal women with hormone receptor-positive early breast cancer, the
first-line treatment of postmenopausal women with hormone receptor-positive or hormone
receptor-unknown locally advanced or metastatic breast cancer and the treatment of
advanced breast cancer in postmenopausal women with disease progression, following
tamoxifen therapy.
Executive Vice President, Oncology Business Unit, said: “Arimidex and Casodex are
important established medicines and we are pleased that Juvisé Pharmaceuticals will
now take on the work of making sure patients continue to have access to them. Today’s
agreement is part of a broader strategy of reducing our portfolio of mature medicines to
reallocate resources towards developing our pipeline of new medicines.”
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Baxter (USA) Announces Preliminary Net Sales for the Fourth-Quarter and
Full-Year 2019 and Announces Preliminary Full-Year 2020 Guidance
• Fourth-quarter net sales of $3.0 billion increased 7% on a reported
basis and 9% on an operational basis
• Full-year net sales of $11.4 billion increased 2% on a reported
basis and 5% on an operational basis
• Both fourth-quarter GAAP operating margin and adjusted
operating margin expected to be above previous guidance ranges of
15.2%-15.9% and 18.5%-19.0% of sales, respectively
• Baxter expects full-year 2020 sales growth of 4%-5% on both a
reported and constant currency basis, and operating margin to be
17%-18% on a reported basis and 19%-20% on an adjusted basis
• Company expects to report complete third and fourth quarters and
full-year 2019 results as soon as reasonably practicable, but no later
than the end of the first quarter of 2020
"Our fourth quarter reflects Baxter's strongest operational sales
growth since the 2015 spin-off of Baxalta, driven by outstanding
performance across all our global businesses and regions," said
chairman and chief executive officer. "We're continuing to
execute on our innovation pipeline and augment our businesses
through strategic partnerships and acquisitions, all in pursuit of
returning even greater value to our stakeholders now and in the
years ahead."
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Bristol-Myers Squibb (USA) Completes Divestment of Manufacturing
Facility in Anagni, Italy
Bristol-Myers Squibb Company announced that it has completed its previously announced divestment of its oral solid,
biologics, and sterile product manufacturing and packaging facility in Anagni, Italy, to Catalent Inc. The divestiture is
part of Bristol-Myers Squibb’s strategy to simplify and to realign its business portfolio to address changes in its
business and the future requirements of its evolving pipeline. The Anagni facility manufactures and packages
cardiovascular, anticancer, metabolic and anti-inflammatory medicines as well as non-penicillin-based antibiotics,
antivirals, analgesics as injectables and biologics. The Company is focusing resources on its highest priorities of
discovering, developing and delivering transformational medicines for patients facing serious diseases.Bristol-Myers
Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative
medicines that help patients prevail over serious diseases.
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New York Life To Acquire Cigna's Group (USA) Life And Disability
Insurance Business
New York Life, America's largest mutual life insurer, and Cigna, a leading
global health service company, announced that they have entered into a
definitive agreement whereby New York Life will acquire Cigna's group life
and disability insurance business for $6.3 billion. The acquisition is expected
to close in the third quarter of 2020, subject to applicable regulatory approvals
and other customary closing conditions.The group life and disability insurance
business will operate within New York Life's portfolio of strategic businesses,
which, like Cigna's Group Insurance business, are industry leaders, highly
profitable, and fully support New York Life's core retail life insurance
franchise. These businesses reinforce New York Life's overall financial
strength by generating capital that can contribute to its surplus, dividends, and
earnings, which directly benefits the company's policy owners. In addition, the
Cigna Group Insurance employees, as well as the employees who primarily
support the acquired business, will transfer to New York Life.
"This transaction increases the value we can deliver to our policy owners,
strengthens our well-defined business model, and adds millions of
customers to the New York Life family," said New York Life Chairman and
CEO. "Cigna's group life and disability business enhances our portfolio of
strategic businesses and is led by an experienced management team and
high-quality workforce, who we look forward to welcoming to our
company. We are fully committed to making this transition as seamless as
possible for employees and clients alike."
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Community Health Systems (USA) Completes Divestiture of Virginia
Hospitals
Community Health Systems, Inc. announced that subsidiaries of the Company have completed the sale of three
Virginia hospitals – 300-bed Southside Regional Medical Center in Petersburg, 105-bed Southampton Memorial
Hospital in Franklin and 80-bed Southern Virginia Regional Medical Center in Emporia, and their associated assets to
subsidiaries of Bon Secours Mercy Health, Inc. The effective date of the transaction is January 1, 2020.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 subsidiaries,
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. Shares in Community
Health Systems, Inc. are traded on the New York Stock Exchange under the symbol “CYH.”
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Royal DSM (Netherlands) completes acquisition of Royal CSK
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces the
completion of the acquisition of a 100% interest in specialty dairy solutions provider Koninklijke CSK Food
Enrichment C.V. (“CSK”) for a cash consideration of about €150 million. The acquisition of CSK was first
announced on 18 November. The highly complementary combination of DSM’s dairy business and CSK’s business
greatly strengthens DSM’s ability to serve the needs of dairy industries worldwide, and makes the company
well-placed to address the fast-growing and attractive dairy cultures markets.
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Lilly (USA) Announces Agreement to Acquire Dermira
Eli Lilly and Company and Dermira, Inc. announced a definitive agreement for
Lilly to acquire Dermira for $18.75 per share, or approximately $1.1 billion, in an
all-cash transaction. Dermira is a biopharmaceutical company dedicated to
developing new therapies for chronic skin conditions. The acquisition will expand
Lilly's immunology pipeline with the addition of lebrikizumab, a novel,
investigational, monoclonal antibody designed to bind IL-13 with high affinity
that is being evaluated in a Phase 3 clinical development program for the
treatment of moderate-to-severe atopic dermatitis in adolescent and adult
patients, ages 12 years and older. Lebrikizumab was granted Fast Track
designation from the U.S. Food and Drug Administration (FDA) in December
2019. The acquisition of Dermira will also expand Lilly's portfolio of marketed
dermatology medicines with the addition of QBREXZA® (glycopyrronium)
cloth, a medicated cloth approved by the FDA for the topical treatment of primary
axillary hyperhidrosis (uncontrolled excessive underarm sweating).
"People suffering from moderate-to-severe atopic dermatitis have significant
unmet treatment needs, and we are excited about the potential that
lebrikizumab has to help these patients," said Lilly senior vice president and
president of Lilly Bio-Medicines "The acquisition of Dermira is consistent
with Lilly's strategy to augment our own internal research by acquiring
clinical phase assets in our core therapeutic areas and leveraging our
development expertise and commercial infrastructure to bring new medicines
to patients. This acquisition provides an opportunity to add a promising Phase
3 immunology compound for atopic dermatitis, while also adding an
approved dermatology treatment for primary axillary hyperhidrosis. We look
forward to completing the acquisition and continuing Dermira's excellent
work."
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Fresenius (Germany) Helios acquires leading private hospital in Colombia
Quirónsalud, the largest private hospital group in Spain and part of Fresenius Helios, has signed an agreement to acquire Centro
MédicoImbanaco (CMI) in Cali, further expanding the company’s presence in Colombia’s attractive private hospital market. CMI
is located in a central district of Cali, the biggest city in southwestern Colombia with a population of 2.4 million. As one of the most
prestigious private hospitals in Latin America, repeatedly recognized for its medical quality as well as its state-of-the-art
infrastructure and medical technology, CMI offers a comprehensive range of medical specialties and services. The hospital has about
350 beds, 17 operating rooms and 250 consultation rooms, and generated sales of about €130 million in 2018. The total
consideration amounts to approximately €300 million. The purchase of CMI is another important step in strengthening
Quirónsalud’s presence in Colombia’s growing and consolidating healthcare services market. With this acquisition, Quirónsalud
becomes one of the leading private hospital operators in the country. The transaction is expected to close in the first quarter of 2020,
pending anti-trust clearance. Fresenius expects CMI to be accretive to Group net income* in fiscal year 2020.
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GSK (UK) completes divestment of rabies and tick-borne encephalitis
vaccines to Bavarian Nordic
GlaxoSmithKline plc announced the completion of the divestment of travel vaccines Rabipur (tradename Rabavert in the US)
for the prevention of rabies, and Encepur for the prevention of tick-borne encephalitis, to Bavarian Nordic. Consistent with the
terms of the agreement first announced on October 21st 2019, GSK has received an upfront payment of EUR308 million
(£263m), and in due course will receive further milestone payments for a total consideration of up to EUR955 million. The
decision to divest these brands supports GSK’s strategic intent to increase focus and reinvest in growth assets, innovation and a
simplified supply chain in its vaccines business.Rabipur is a well-established life-saving vaccine (rabies virus causes acute
invariable fatal disease) with 30 years of market experience supported by extensive clinical and safety evidence and WHO
pre-qualification. It is indicated both in persons bitten by suspect animals (PEP ) and non-immune subjects at risk of rabies (PrEP
).Encepur is indicated for active immunization of high-risk populations against tick-borne encephalitis (TBE). It has unique
dosing flexibility supported by proven efficacy and long-term persistence data.
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Illumina(USA) and Pacific Biosciences Announce Termination of Merger
Agreement
Illumina, Inc. and Pacific Biosciences of California, Inc.
announced that they have mutually agreed to terminate their
merger agreement, previously announced on November 1, 2018,
under which Illumina would acquire Pacific Biosciences at a fully
diluted enterprise value of approximately $1.2 billion in an
all-cash transaction. Considering the lengthy regulatory approval
process the transaction has already been subject to and continued
uncertainty of the ultimate outcome, the parties decided that
terminating the agreement is in the best interest of their respective
shareholders and employees. In accordance with the merger
agreement, Illumina will pay Pacific Biosciences a termination
fee of $98 million.
“We believe this proposed combination would have broadened
access to Pacific Biosciences sequencing technology,
significantly expanded and accelerated innovation, and
ultimately increased the clinical utility and impact of
sequencing,” said President and Chief Executive Officer of
Illumina. “I’d like to thank our employees, as well as the
Pacific Biosciences team, for their unwavering dedication and
commitment throughout this process. Moving forward, we will
continue to look for ways to increase the impact and benefit of
sequencing technologies for researchers, clinicians, and most
importantly, patients.”
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Johnson & Johnson (USA) Announces Agreement to Acquire Remaining
Stake in Verb Surgical Inc.
Dedicated to shaping the next frontier of surgery, Johnson & Johnson announced an
agreement to acquire the remaining stake in Verb Surgical Inc. following a successful
strategic collaboration with Verily, an Alphabet company. Verb Surgical’s
world-class robotics and data science capabilities combined with Johnson &
Johnson’s health care leadership and global reach advance the company’s vision to
make medical interventions smarter, less invasive and more personalized.Combining
groundbreaking robotics, enhanced visualization, advanced instrumentation,
machine learning, data analytics and powerful end-to-end connectivity, Johnson &
Johnson continues to strengthen its digital surgery portfolio. With a community of
world-class experts, including Dr. Fred Moll, robotics pioneer leading digital surgery
development; Ethicon’s deep knowledge in surgery and instrumentation; Verb
Surgical’s leading-edge robotics and data science expertise; and Verily’s digital
technology and engineering expertise, Johnson & Johnson is well-positioned to bring
its unique insights and experience in science, medical technology and digital
solutions to medical interventions, including open surgery, laparoscopic,
percutaneous and endoluminal procedures.
“We have reached this important milestone thanks to the progress the Verb
Surgical team has made with their digital surgery platform and the strong
collaboration with Verily, Ethicon[ii], and the clinicians around the world who
shared their passion, deep insights and clinical expertise,” saidWorldwide
Chairman, Medical Devices, Johnson & Johnson. “We are building a truly
differentiated digital surgery ecosystem to change the standard of care for
generations to come, and our collaboration with Verily has enabled us to advance
our vision to help improve outcomes for patients around the world.”
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Medtronic (Ireland) Acquires Klue
Medtronic plc, the global leader in medical technology, announced it has completed the
acquisition of Klue, a software company focused on behavior tracking that can provide real-time
insights into when a person is consuming food. Klue’s technology is expected to be incorporated
into the Medtronic Personalized Closed Loop (PCL) insulin pump system, currently in
development. The PCL system is designed to automate insulin delivery in a way that is real-time,
personalized and adapts to the user, with a goal of dramatically simplifying diabetes management
for the patient. In addition, the Klue technology can be leveraged to enhance the company’s
market-leading analytics and insights in their smart1 CGM technology to help people using
multiple daily injections (MDI) stay ahead of high and low glucose events. Klue has developed
technology that automatically recognizes when a person is eating as well as how fast and how
much that person consumes. By using gesture sensing via activity trackers combined with
analytics technology, Klue has developed fine motor artificial intelligence software that can
detect meals and provide insights into user eating behaviors. Because food consumption is
intrinsically related to insulin requirements for people living with diabetes, the ability to automate
meal identification along with the corresponding insulin delivery is an unmet need that could
greatly simplify living with this disease.
“Bringing Klue and their unique meal detection capabilities into our organization will
accelerate our progress to help people with diabetes live with greater freedom and better
health,” said president of the Advanced Insulin Management division, which is part of the
Diabetes Group at Medtronic. “Based on our learnings from a first-generation hybrid closed
loop system around the importance of simplifying diabetes management, we believe the
Personalized Closed Loop system will be transformational for diabetes management, and the
integration of the Klue technology helps clears the path to a true hands-free closed loop
system.”
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Medtronic (Ireland) Acquires Stimgenics, Pioneer of DTM™, a Novel
Spinal Cord Stimulation Therapy
Medtronic plc announced it has acquired Stimgenics, LLC, a privately-held company based in
Bloomington, Illinois, that has pioneered a novel spinal cord stimulation (SCS) waveform known
as Differential Target Multiplexed (DTM™) Spinal Cord Stimulation. The therapy, which is
delivered via the Medtronic Intellis™ platform, is a new and unique programming option to treat
patients with chronic pain. Three month results from a randomized control trial (RCT) evaluating
DTM versus conventional SCS will be presented at the upcoming North American
Neuromodulation Society (NANS) 23rd Annual Meeting on January 23-26 in Las Vegas. The
RCT will continue to evaluate outcomes through 12 months follow-up. The DTM waveform may
engage a novel mechanism that modulates both neurons and glial cells, expanding the
understanding of SCS mechanisms of action. The DTM waveform has been studied in animal
models, showing statistically significant reversal of pain behaviors compared to either low
frequency or high frequency alone.1,2 In addition, preclinical studies investigating the genome of
nerve-injured animals suggests that the DTM waveform has a greater impact in the neural-glial
interaction than other frequencies alone. Decades of basic science research have expanded the
understanding of the role of glial cells in the nervous system, which outnumber neurons 12:1 in
the spinal cord.3-6 Glial cells are no longer thought to be only “glue” in the brain and spinal cord,
but active contributors to neural processing and various disease states including chronic pain.
“Stimgenics’ research is deeply rooted in clinical science that began with animal work more
than a decade ago. Our preclinical data demonstrated that the modulation of both neurons and
glial cells may return glial cells to their normal state and modify how they interact with
neurons, which could normalize biological processes and break the pain cascade,” said
Co-founder and director of research at Millennium Pain Center in Bloomington, Illinois, and
founder and lead investigator of Stimgenics, LLC. “I’m thrilled that Medtronic has acquired
a therapy that has the potential to significantly improve outcomes for chronic pain patients.”
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Merck (USA) Begins Tender Offer to Acquire ArQule
Merck known as MSD outside the United States and Canada, is commencing, through a subsidiary, a cash tender offer to purchase all outstanding
shares of common stock of ArQule, Inc. On Dec. 9, 2019, Merck announced its intent to acquire ArQule. Upon the successful closing of the tender
offer, stockholders of ArQule will receive $20 in cash for each share of ArQule common stock validly tendered and not validly withdrawn in the
offer, without interest and less any required withholding taxes. Following the purchase of shares in the tender offer, ArQule will become a
wholly-owned subsidiary of Merck. Merck will file today with the U.S. Securities and Exchange Commission (the “SEC”) a tender offer
statement on Schedule TO, which provides the terms of the tender offer. Additionally, ArQule will file with the SEC a
solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the ArQule board of directors that their
stockholders accept the tender offer and tender their shares. The tender offer will expire at one minute past 11:59 pm Eastern Time on January 15,
2020, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender
offer is subject to customary terms and conditions, including the tender of a number of shares which, together with shares then owned by Merck
(if any), represents a majority of the outstanding shares of common stock of ArQule, and the expiration or the termination of the waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is expected to close early in the first quarter of 2020.
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Merck (USA) Animal Health Completes Acquisition of Vaki to Further Broaden Its
Leadership Position in Aquaculture to Advance Fish Health and Welfare
Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J.,
USA announced the completion of its acquisition of Vaki, a leader in fish
farming and wild fish conservation monitoring equipment and real-time
video monitoring technology to advance fish health and welfare, from
Pentair, a leading global water treatment company. The announcement
further positions Merck Animal Health as a global leader in broadening its
aquaculture portfolio by expanding into complementary fish farming and
conservation areas to generate outcomes with precision farming and fish
welfare solutions, which complement its existing portfolio of vaccines and
pharmaceuticals. Vaki will be a leading brand under the Biomark business
within Merck Animal Health, focused on a range of equipment, products
and technology for fish counting and size estimation from freshwater to
saltwater rearing, while collecting data and analytics for each stage of fish
production.
“Animal health intelligence and enhanced technology play an
increasingly important role in animal health and care, providing access
to real-time actionable data and insights to help, improve or enhance
animal management and health outcomes,” said President, Merck
Animal Health. “We continue to execute upon our strategy to expand
and add breadth to our portfolio and its technology. We are at the
technological forefront of shaping the future of animal health through
our commitment to leveraging our scientific capabilities and expertise
through comprehensive solutions to manage the health and well-being
of animals. We are excited to take this step forward with Vaki, as we add
leading technology and services, which extend the range of solutions in
aquaculture we can provide to our customers.”
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Rite Aid Corporation (USA) Reports Fiscal 2020 Third Quarter Results
• Revenues from continuing operations for the quarter were $5.46 billion compared to revenues from
continuing operations of $5.45 billion in the prior year's quarter.
• Retail Pharmacy Segment same store sales from continuing operations for the third quarter decreased 0.1
percent over the prior year period, consisting of a 0.1 percent increase in pharmacy sales and a 0.5 percent
decrease in front-end sales. Front-end same store sales, excluding cigarettes and tobacco products,
increased 1.0 percent.
• Net income from continuing operations was $52.3 million or $0.98 per share compared to last year's third
quarter net loss from continuing operations of $17.3 million or $0.33 per share.
• Adjusted EBITDA from continuing operations was $158.1 million or 2.9 percent of revenues for the third
quarter compared to last year's third quarter Adjusted EBITDA from continuing operations of $142.8
million or 2.6 percent of revenues, an increase of $15.3 million.
Outlook for Fiscal 2020
• Rite Aid Corporation expects revenues to be between $21.5 billion and $21.9 billion in fiscal 2020 with
same store sales expected to range from an increase of 0.0 percent to an increase of 1.0 percent over fiscal
2019.
• Net loss is expected to be between $174.0 million and $204.0 million.
• Adjusted EBITDA is expected to be between $515.0 million and $545.0 million.
• Adjusted net income per share is expected to be between $0.13 and $0.55.
• Capital expenditures are expected to be approximately $230 million.
"Our team delivered a strong quarter that provides us with momentum as we prepare to roll out our
long-term strategy and position Rite Aid Corporation as an innovative leader in our industry," said Rite
Aid Corporation CEO. "Adjusted EBITDA grew in our retail business due to tight expense control and
prescription count growth in our retail pharmacies, which benefited from solid growth in
immunizations. At the same time, we saw improved pharmacy network management at
EnvisionRxOptions.
19

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Roche (Switzerland) concludes acquisition of Spark Therapeutics, Inc. to
strengthen presence in gene therapy
Roche and Spark Therapeutics, Inc. announced the
completion of the acquisition following the receipt of
regulatory approval from all government authorities required
by the merger agreement.Spark Therapeutics, based in
Philadelphia, Pennsylvania, is a fully integrated, commercial
company committed to discovering, developing and
delivering gene therapies for genetic diseases, including
blindness, haemophilia, lysosomal storage disorders and
neurodegenerative diseases. Spark Therapeutics will continue
to operate as an independent company within the Roche
Group.
Commenting on this important step forward, CEO of
Roche, said, “We are excited about this important
milestone because we believe that together, Roche and
Spark will be able to significantly improve the lives of
patients through innovative gene therapies. This
acquisition supports our long-lasting commitment to
bringing transformational therapies and innovative
approaches to people around the world with serious
diseases.”
Description
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Sanofi (France) commences tender offer for acquisition of Synthorx,
Inc.
Sanofi announced today that it intends to commence a tender offer to acquire all of the outstanding shares of common stock of Synthorx, Inc.for $68
per share in cash, without interest thereon and net of any applicable withholding taxes. The Offer is being made pursuant to the Agreement and Plan
of Merger, dated as of December 7, 2019 (as it may be amended from time to time, the “Merger Agreement”), by and among Synthorx, Sanofi and
Thunder Acquisition Corp., a Delaware corporation and an indirect, wholly-owned subsidiary of Sanofi (“Purchaser”). The Offer is scheduled to
expire one minute past 11:59 p.m., Eastern Time, on Wednesday, January 22, 2020, unless the Offer is extended in accordance with the Merger
Agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). The consummation of the Offer is
subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Synthorx common stock, the expiration
or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the
successful completion of the Offer, Purchaser will merge with and into Synthorx pursuant to Section 251(h) of the General Corporation Law of the
State of Delaware, with Synthorx continuing as the surviving corporation and becoming an indirect, wholly-owned subsidiary of Sanofi (the
“Merger”). At the effective time of the Merger, the outstanding shares of common stock of Synthorx not tendered in the Offer will be converted into
the right to receive the same $68 per share in cash that they would have received had they tendered their shares in the Offer.
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Walgreens Boots Alliance (USA) Reports Fiscal 2020 First Quarter Results
• Sales increased 1.6 percent to $34.3 billion, up 2.3 percent on a constant currency basis
• Operating income decreased 27.6 percent to $1.0 billion; Adjusted operating income
decreased 15.6 percent to $1.5 billion, down 15.4 percent on a constant currency basis
• EPS decreased 19.8 percent to $0.95; Adjusted EPS decreased 6.0 percent to $1.37,
down 5.7 percent on a constant currency basis
• Net cash provided by operating activities was $1.1 billion, an increase of $601 million;
Free cash flow was $674 million, an increase of $684 million
Fiscal 2020 outlook
• Company maintained its guidance of roughly flat growth in fiscal 2020 adjusted EPS
on a constant currency basis
Transformational Cost Management Program
• On track to deliver in excess of $1.8 billion in annual cost savings by fiscal 2022
Strategic updates announced after end of quarter
• WBA agreed to create German wholesale joint venture with McKesson
• Kroger and Walgreens formed group purchasing organization
Executive Vice Chairman and CEO said, “We are maintaining our outlook for the
year despite a soft first quarter. We are confident our strategic plans are the right ones
to drive long-term sustainable growth going forward. In addition, during the quarter
we were very satisfied with the progress made in our Transformational Cost
Management Program and with the strong cash flow we delivered.”
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Pfizer (USA) Declares First-Quarter 2020 Dividend And Announces Upcoming
Investor Day To Highlight Strength Of Innovative R&D Pipeline
Pfizer Inc. announced that its board of directors declared a 38-cent per share first-quarter
2020 dividend on the company’s common stock, payable March 6, 2020 to holders of the
Common Stock of record at the close of business on January 31, 2020. Pfizer increased the
dividend over the fourth-quarter 2019 dividend by approximately 6 percent to 38 cents from
36 cents per share. The first-quarter 2020 cash dividend will be the 325th consecutive
quarterly dividend paid by Pfizer.Pfizer also announced plans to host an Investor Day on
Tuesday, March 31, 2020, starting at 9:00 a.m. EDT, at its global headquarters in New York,
NY. Pfizer business executives and scientific leadership will provide updates on the
company’s progress in advancing its R&D pipeline, specifically on product candidates with
blockbuster potential that are expected to launch by 2025.Invitations for in-person
attendance will be distributed in coming weeks. A live webcast, including audio, video and
presentation slides, will be accessible on the Pfizer’s Investor Relations website
(www.pfizer.com/investors) at the time of the meeting. Interested parties unable to attend
in-person or watch the live webcast will be able to view and listen to an archived copy of the
webcast, which will be available on Pfizer's Investor Relations website following the
conclusion of the event.
“The dividend increase is a testament to our commitment to returning capital to
shareholders and reflects our continued confidence in the business and in our pipeline,”
stated Pfizer chief executive officer. “It also reinforces that our focus on creating
meaningful value for patients benefits all our stakeholders.”
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Healthcare Industry

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AbbVie (USA) Receives European Commission Approval of RINVOQ™ (upadacitinib) for
the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis
24
Solution Description
AbbVie, a research-based global biopharmaceutical company, announced that the European Commission (EC) has approved RINVOQ™ for the treatment of adult patients with moderate to severe active rheumatoid
arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).6 RINVOQ is a once-daily selective and reversible JAK inhibitor and may be used
as monotherapy or in combination with methotrexate (MTX).The EC approval of RINVOQ was supported by data from the global Phase 3 SELECT rheumatoid arthritis program, which evaluated nearly 4,400 patients
with moderate to severe active rheumatoid arthritis in five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY.1-5 The studies include
assessments of efficacy, safety and tolerability across a variety of patients, including those who failed or were intolerant to biologic DMARDs and who were naïve or inadequate responders (IR) to MTX.Across the
SELECT Phase 3 studies, RINVOQ met all primary and ranked secondary endpoints.Overall, both low disease activity (assessed by DAS28-CRP≤3.2) and clinical remission rates (assessed by DAS28-CRP<2.6) were
consistent across patient populations, with or without MTX.
Highlights included:
• In SELECT-COMPARE, RINVOQ plus MTX demonstrated significantly higher remission rates (as observed by DAS28-CRP<2.6) versus placebo plus MTX (29 percent vs 6 percent at week 12; multiplicity-controlled
p≤0.001) and vs HUMIRA® (adalimumab) plus MTX (29 percent vs 18 percent at week 12; nominal p≤0.001) in MTX-IR patients.
• More patients treated with RINVOQ alone achieved remission (as observed by DAS28-CRP<2.6) than those treated with MTX in MTX-IR patients in SELECT-MONOTHERAPY (28 percent vs 8 percent at week 14;
multiplicity-controlled p≤0.0001) and in MTX-naïve patients in SELECT-EARLY (48 percent vs 18 percent at week 24; multiplicity-controlled p<0.001).
• RINVOQ also demonstrated significantly greater inhibition of structural joint damage progression, as measured by modified total Sharp score change from baseline, as monotherapy compared to MTX (0.1 vs 0.7 at
week 24; multiplicity-controlled p<0.01) in MTX-naïve patients and in combination with MTX compared to placebo plus MTX (0.2 vs 0.9 at week 26; multiplicity-controlled p≤0.001) in MTX-IR patients.
• The most commonly reported adverse drug reactions were upper respiratory tract infections (13.5 percent), nausea (3.5 percent), blood creatine phosphokinase increased (2.5 percent) and cough (2.2 percent).6 The most
common serious adverse reactions were serious infections.

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CVS Health (USA) Launches Transform Oncology Care Program to Help
Improve Patient Outcomes and Lower Overall Costs
25
CVS Health announced Transform Oncology Care , anchored on a first-of-its-kind precision medicine strategy for payors. The program uses genomic testing
results at the point-of-prescribing to help patients start on the best treatment, faster and in addition, matches eligible patients to clinical trials. Transform
Oncology Care also uses the Company's local footprint and unique assets to improve patient outcomes and lower overall costs at every point of the cancer
care journey.The innovative precision medicine strategy, delivered in close coordination with oncologists, uses results of broad-panel gene sequencing tests
and the latest National Comprehensive Cancer Network (NCCN) treatment and supportive care guidelines to help oncologists identify and start their patients
on the most precise, appropriate treatment regimen based on their clinical and genetic profiles. Therapeutic regimens that align to NCCN guidelines,
including those matched with the results of the broad-panel gene sequencing tests, will automatically receive prior authorization approval, speeding time to
start of the therapy for patients. The strategy is enabled by an innovative collaboration with Tempus, a technology company advancing precision medicine
through the practical application of artificial intelligence in healthcare.The program includes CVS Health nurse-led care management, integrated with payor's
existing programs, to create a more personalized experience for patients and their caregivers and close existing gaps in care. In addition, payors can adopt
value-based contracts that employ provider networks to drive high-quality care and lower costs. Transform Oncology Care also uses the CVS Health's
accessible, local footprint, connected data and integrated systems to help better identify and intervene with patients who could benefit from preventive or
screening services.

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Allergan (Ireland) Receives U.S. FDAApproval ForUbrelvy™ For The
Acute Treatment Of Migraine With Or Without Aura In Adults
26
Allergan plc announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for UBRELVY™
(ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVY™ is the first and only orally-administered calcitonin
gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. Migraine is a neurological disease
characterized by intermittent migraine attacks with symptoms that are often incapacitating. Migraine afflicts 31 million Americans and is the third
most common disease and second leading cause of disability worldwide.In clinical trials supporting the FDA's approval, UBRELVY™ provided
quick pain relief for the majority of migraine patients. UBRELVY™ also met co-primary endpoints of freedom from pain and freedom from the
most bothersome symptom (nausea, hypersensitivity to light, or hypersensitivity to sound), a recent, more stringent standard of efficacy the FDA
set in 2018. UBRELVY™ provided lasting relief up to 24 hours as well. UBRELVY™ works in a new way by blocking CGRP, a protein that is
released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments are
known to do. UBRELVY™ is non-narcotic, not scheduled, and does not have addiction potential. It has been approved with two dose strengths,
50 mg and 100 mg, and is specially designed so healthcare providers can provide a personalized treatment approach for appropriate patients.

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XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of
Metastatic Castration-Sensitive Prostate Cancer
27
Pfizer Inc. and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application
(sNDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated
that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds
to a medical or surgical treatment that lowers testosterone. With this approval, XTANDI is now the first and only oral treatment approved by the FDA in three
distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. The approval is based on
results from ARCHES, a randomized Phase 3 study which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free
survival (rPFS).Data from the ARCHES trial demonstrated that the use of XTANDI plus androgen deprivation therapy (ADT) significantly reduced the risk
of radiographic progression or death by 61 percent compared to placebo plus ADT (n=1,150; hazard ratio [HR]: 0.39 [95% confidence interval (CI):
0.30-0.50]; p<0.0001). Overall survival data were not mature at the time of final rPFS analysis. The safety analysis of the ARCHES trial is generally
consistent with the safety profile of XTANDI in previous clinical trials in CRPC. In ARCHES, common adverse reactions (Grade 1 to 4 ARs; occurring in at
least 5% of patients) that were reported more frequently in patients treated with XTANDI plus ADT vs placebo plus ADT included hot flush (27% vs 22%),
asthenic conditions (24% vs 20%), hypertension (8.0% vs 5.6%), fractures (6.5% vs 4.2%), and musculoskeletal pain (6.3% vs 4.0%).

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FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumabvedotin-ejfv) for
People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
28
Astellas Pharma Inc. and Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV™ for the treatment of
adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before
(neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV is approved under the FDA’s Accelerated Approval Program based on tumor
response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. PADCEV is the first FDA approved treatment
in the U.S. for these patients. It is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed
in bladder cancer.PADCEV was evaluated in the pivotal trial EV-201, a single-arm phase 2 multi-center trial that enrolled 125 patients with locally advanced or metastatic
urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy.1 In the study, the primary endpoint of confirmed objective
response rate (ORR) was 44 percent per blinded independent central review (55/125; 95% Confidence Interval [CI]: 35.1, 53.2). Among patients treated with the single agent
PADCEV, 12 percent (15/125) experienced a complete response, meaning no cancer could be detected at the time of assessment, and 32 percent (40/125) experienced a partial
response, meaning a decrease in tumor size or extent of cancer in the body. The median duration of response (DoR), a secondary endpoint, was 7.6 months (95% CI: 6.3, not
estimable [NE]). The most common serious adverse reactions (≥3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%),
acute kidney injury (3%), dyspnea (3%), and rash (3%). The most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). The most common
adverse reactions (≥20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea
(42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade ≥3 adverse reactions (≥5%) were rash (13%), diarrhea (6%) and fatigue (6%).

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Lynparza recommended by FDA advisory committee for 1st-line maintenance
treatment of germline BRCA-mutated metastatic pancreatic cancer
29
AstraZeneca and MSD Inc., Kenilworth, NJ, US announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC)
voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic
adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy. In August 2019, the FDA
accepted the supplemental New Drug Application (sNDA) for Lynparza for this indication with Priority Review and set a Prescription Drug User Fee Act (PDUFA)
date for the fourth quarter of 2019.The sNDA submission was based on the positive results from the Phase III POLO trial published in The New England Journal
of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting. The results showed a statistically significant and clinically
meaningful improvement in progression-free survival and reduced the risk of disease progression or death by 47% based on a hazard ratio of 0.53 (p=0.0038).
Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs.
3.8 months on placebo.The benefit of maintenance with Lynparza was seen consistently across a range of clinically meaningful endpoints. At each time point, from
six months onwards, more than twice as many patients treated with Lynparza showed no disease progression vs. those on placebo. In patients with measurable
disease at baseline, 23% responded to Lynparza vs.12% on placebo and had a median duration of treatment in excess of two years (24.9 months) vs 3.7 months on
placebo. Overall survival (OS), a secondary endpoint, at interim analysis was 18.9 months for Lynparza vs. 18.1 months for placebo but did not reach statistical
significance (HR=0.90; p=0.68). The safety and tolerability profile of Lynparza in the Phase III POLO trial was in line with that observed in prior clinical trials.

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Accelerated Approval of AstraZeneca (UK) and Daiichi Sankyo’s Enhertu based on the
DESTINY-Breast01 trial that showed clinically meaningful and durable responses
30
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced that the US Food and Drug Administration (FDA) has approved Enhertu
(fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more
prior anti-HER2 based regimens in the metastatic setting.This indication is approved under Accelerated Approval based on tumour response rate and duration of
response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.Enhertu is a
HER2-directed antibody-drug conjugate (ADC) and the FDA approval is based on the results of the registrational Phase II trial DESTINY-Breast01 of Enhertu
(5.4mg/kg) monotherapy in patients with HER2-positive metastatic breast cancer. All patients received prior trastuzumab, trastuzumab emtansine and 66% had
prior pertuzumab.The Phase II trial results showed a confirmed objective response rate of 60.3% (n=111, 95% CI 52.9-67.4) including a 4.3% complete response
rate (n=8) and a 56.0% partial response rate (n=103). A median duration of response of 14.8 months (95% CI 13.8-16.9) was demonstrated as of 1 August 2019.1
In addition, a median progression-free survival of 16.4 months (95% CI 12.7-not estimable), based upon a median duration of follow up of 11.1 months, was
recently presented at the San Antonio Breast Cancer Symposium and published online in The New England Journal of Medicine.The safety of Enhertu has been
evaluated in a pooled analysis from both the Phase II trial DESTINY-Breast01 and the earlier Phase I trial among a total of 234 patients with unresectable or
metastatic HER2-positive breast cancer who received at least one dose of Enhertu (5.4mg/kg).

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Lokelma approved in China for the treatment of adult patients with
hyperkalaemia
31
AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in China for the treatment of adult patients with
hyperkalaemia (elevated levels of potassium in the blood). The approval by the National Medical Products Administration (NMPA) was
based on positive results from the extensive Lokelma clinical trial programme and a pharmacodynamic study in China which showed that
patients receiving Lokelma experienced a significant, rapid and sustained reduction of potassium in the blood. In 2019, the NMPA
included Lokelma on the Accelerated Approval list of “Overseas New Drugs in Clinical Urgent Needs for China”, recognising the
significant unmet need for effective medicines treating hyperkalaemia.The Lokelma clinical trials programme includes three
double-blinded, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months.
These trials showed that for patients receiving Lokelma, the median time to achieving normal potassium levels in the blood was 2.2 hours,
with 98% achieving normal levels within 48 hours from baseline.Lokelma also demonstrated a rapid reduction of potassium in the blood
as early as one hour with one dose and a sustained treatment effect for up to one year.Lokelma was well tolerated, with few serious
adverse events.

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Boston Scientific (USA) Receives FDA Clearance For World's First Single-Use
Duodenoscope, EXALT™ Model D
32
Boston Scientific Corporation announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT™ Model D Single-Use Duodenoscope for
use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is the first and only FDA cleared single-use
(disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely
access to this device. This groundbreaking device has been developed as an alternative to reusable duodenoscopes, eliminating the need for duodenoscope
reprocessing and repairs, and allowing physicians to use a new, sterile device for every procedure. The EXALT Model D Duodenoscope builds on the familiar
design of standard reusable duodenoscopes so that physicians experience a minimal learning curve when adopting this technology.Every year, more than 1.5
million ERCPs are performed worldwide using duodenoscopes to diagnose and treat various pancreatic and biliary conditions.Reusable duodenoscopes are put
through a rigorous disinfection process between uses in different patients and the vast majority of procedures with these devices are carried out safely and
effectively; however, there have been a small number of cases in which infections have been transmitted between patients via contaminated devices, despite
adherence to established protocols. As a result, the FDA has been working with duodenoscope manufacturers, medical societies, physicians and other stakeholders
to address this concern. The FDA recently issued a recommendation that healthcare providers transition to duodenoscopes with disposable components or fully
disposable devices, when they are available, and held an advisory committee meeting to discuss this process and other issues related to reducing infection
transmission by reusable duodenoscopes.

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Bristol-Myers Squibb (USA) Announces Submission of Biologics License Application
for CAR T-Cell Therapy LisocabtageneMaraleucel (liso-cel) to FDA
33
Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration
(FDA) for lisocabtagenemaraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising
individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma
(LBCL) after at least two prior therapies. The submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating
liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Bristol-Myers Squibb
recently presented data from this pivotal study at the American Society of Hematology annual meeting. Liso-cel has been granted Breakthrough
Therapy (BT) and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA for relapsed/refractory aggressive large B-cell
non-Hodgkin lymphoma (NHL), including DLBCL, not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal
B-cell lymphoma (PMBCL) or Grade 3B follicular lymphoma (FL) and Priority Medicines (PRIME) scheme by the European Medicines Agency for
relapsed/refractory DLBCL.Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL, accounting for three out of every five
cases. Approximately one-third of patients with DLBCL relapse after receiving first-line treatment, and about 10% have refractory disease. Historically,
median life expectancy for patients who relapse or are refractory to current standard of care treatments is approximately six months.

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Bristol-Myers Squibb (USA) Receives European Commission Approval for Revlimid® (lenalidomide) in Combination
with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma
34
Bristol-Myers Squibb Company announced that the European Commission (EC) has approved a new indication for Revlimid (lenalidomide), in combination with
rituximab (anti-CD20 antibody), for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). This combination of Revlimid
and rituximab (R2) is the first chemotherapy-free combination regimen approved for patients with FL by the EC.FL is a subtype of indolent, but incurable,
non-Hodgkin lymphoma (NHL) which is associated with immune system dysfunction.1,2 There remains an unmet medical need for novel treatments for patients
who have relapsed or become refractory to their previous treatment. It has been hypothesized that the combination therapy, R2, works with the patient’s immune
system using the immunomodulatory properties of Revlimid along with the CD20 antibody-targeted mechanism of action of rituximab in order to help the patient’s
own immune system fight the cancer.The approval of R2 is based primarily on results from the randomized, multi-center, double-blind, phase 3 AUGMENT study,
which evaluated the efficacy and safety of the R² combination versus rituximab plus placebo in patients with previously treated FL (n=295) or marginal zone
lymphoma (MZL) (n=63).In AUGMENT, treatment with R2 demonstrated a statistically significant improvement in the primary endpoint of median
progression-free survival (PFS) (EMA Censoring Rules), evaluated by an independent review committee, versus rituximab plus placebo. The median PFS was 39.4
months for FL patients treated with R2 and 13.8 months for those treated with rituximab-placebo (HR: 0.40; 95% CI, 0.29-0.55; P<0.0001). Median follow-up time
was 29.2 months (range, 0.5-50.9) in the intent to treat population (n=295).

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Daiichi Sankyo Launches Antitumor Agent Bevacizumab Biosimilar for
Intravenous Drip Infusions “Daiichi Sankyo” in Japan
35
Daiichi Sankyo Company, Limited announced that it has launched the antitumor agent bevacizumab BS for intravenous
drip infusions 100 mg and 400 mg “Daiichi Sankyo” in Japan. The product is a pharmaceutical agent developed by Amgen
Inc. (Headquarters: Thousand Oaks, CA, U.S.A; hereafter, “Amgen”) as a biosimilar product to the anti-VEGF humanized
monoclonal antibody, bevacizumab. The product was approved on September 20, 2019 and indicated for unresectable
advanced or recurrent colorectal cancer. Based on the exclusive agreement on the commercialization of biosimilars
concluded with Amgen in July 2016, Daiichi Sankyo is responsible for the distribution and commercialization of the
product in Japan, while Amgen is responsible for its manufacture. Daiichi Sankyo expects that the product will provide
patients with various options for cancer treatment, thereby further contributing to medical treatment in japan.

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U.S. FDAApproves Eisai’s Dayvigo™ (Lemborexant) For Treatment Of
Insomnia In Adult Patients
36
Eisai Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin
receptor antagonist DAYVIGOTM (lemborexant). DAYVIGO was approved for the treatment of insomnia characterized by difficulties with sleep onset and/or
sleep maintenance in adults1. In the United States, DAYVIGO will be commercially available in 5 mg and 10 mg tablets following scheduling by the U.S. Drug
Enforcement Administration (DEA), which is expected to occur within 90 days. The mechanism of action of lemborexant in the treatment of insomnia
characterized by difficulties with sleep onset and/or sleep maintenance is presumed to be through antagonism of orexin receptors. 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 with stronger inhibition effect to
OX2R*. The approval was based on the results of a clinical development program that included two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which
evaluated DAYVIGO versus comparators for up to one month and DAYVIGO versus placebo for six-months, respectively, in a total of about 2,000 adult patients
with insomnia. From these studies results, DAYVIGO demonstrated statistically significant superiorities on sleep onset and sleep maintenance compared to
placebo in both subjective and objective evaluations. Across SUNRISE 2 and SUNRISE 1, DAYVIGO was not associated with rebound insomnia following
treatment discontinuation, and there was no evidence of withdrawal effects following DAYVIGO discontinuation at either dose. In addition, the development
program included multiple safety studies evaluating effects on postural stability, cognition, driving performance and respiratory safety.

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Amgen And Allergan (Ireland) Submit Biologics License Application For ABP 798, Biosimilar
Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration
37
Amgen and Allergan plc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Amgen and Allergan are collaborating on four
oncology biosimilar medicines, two of which have already been approved by the FDA.ABP 798 has been developed as a biosimilar
candidate to Rituxan. Rituxan is a CD20-directed cytolytic antibody that has been approved in many regions for, among other things,
the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin's lymphoma, in combination with
fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis
with glucocorticoids. The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and
toxicology data generated in two clinical studies. The results of these studies confirmed no clinically meaningful differences between
ABP 798 and Rituxan.Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S. and three
that are approved in the European Union (EU).

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AstraZeneca (UK): Imfinzi approved in China for the treatment of unresectable,
Stage III non-small cell lung cancer based on the Phase III PACIFIC trial
38
AstraZeneca announced that it has received marketing authorisation from China’s National Medical Products
Administration (NMPA) for Imfinzi (durvalumab) for the treatment of patients with unresectable, Stage III non-small cell
lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation
therapy (CRT).The approval of Imfinzi is based on results from the primary analysis of progression-free survival (PFS)
and supported by overall survival (OS) from the Phase III PACIFIC trial, both published in The New England Journal of
Medicine. A post-hoc analysis of three-year OS results has sin ce shown that consistent efficacy was maintained for
treatment with Imfinzi after additional follow up.Results demonstrated a statistically significant and clinically meaningful
OS and PFS benefit for treatment with Imfinzi vs. placebo after concurrent CRT. Imfinzi reduced the risk of death by 32%
(equal to a hazard ratio of 0.68) and prolonged the time patients lived without disease progression or death by more than
11 months (median PFS: 16.8 vs. 5.6 months; hazard ratio of 0.52).

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AstraZeneca (UK): Farxiga granted FDA Priority Review for patients with
heart failure with reduced ejection fraction
39
AstraZeneca announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and
granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in
adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). Farxiga is a first-in-class, oral
once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). The Prescription Drug User Fee Act date, the FDA action
date for this supplemental application, is scheduled for the second quarter of 2020. The sNDA was based on results from the landmark Phase
III DAPA-HF trial published in September 2019 in The New England Journal of Medicine, which showed Farxiga on top of standard of care
reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.In September 2019, the FDA granted Fast
Track designation for the development of Farxiga in HF. In August 2019, the FDA also granted Fast Track designation for the development of
Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with and without
T2D.Farxiga is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with T2D. In October
2019, the FDA also approved Farxiga to reduce the risk of hospitalisation for heart failure in patients with T2D and established cardiovascular
disease or multiple CV risk factors.

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Daiichi Sankyo (Japan): ENHERTU® Approved in the U.S. for HER2 Positive Unresectable
or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens
40
Daiichi Sankyo Company, Limited and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved
ENHERTU®, a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2
positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is
approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may
be contingent upon verification and description of clinical benefit in a confirmatory trial.The FDA approval is based on the results of the
single-arm, pivotal phase 2 DESTINY-Breast01 trial of ENHERTU (5.4 mg/kg) monotherapy in 184 female patients with HER2 positive
metastatic breast cancer. Trial results showed a confirmed objective response rate (ORR) of 60.3% (n=111; 95% CI: 52.9-67.4), including
a 4.3% complete response rate (n=8) and a 56.0% partial response rate (n=103).A median duration of response of 14.8 months (95% CI:
13.8-16.9) was demonstrated as of August 1, 2019. In addition, a median progression free survival of 16.4 months (95% CI: 12.7-Not
Estimable), based on a median follow-up of 11.1 months, was recently reported at the San Antonio Breast Cancer Symposium (SABCS)
and published online in The New England Journal of Medicine.

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Gilead (USA) Submits Filgotinib New Drug Application to U.S. Food and Drug
Administration Under Priority Review for Rheumatoid Arthritis Treatment
41
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for
filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis
(RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review. The filing is supported by 52-week data
from the global Phase 3 FINCH clinical program, which evaluated the efficacy and safety of filgotinib in 3,452 patients with moderate to severely
active RA. In the FINCH studies, filgotinib met its primary endpoints and demonstrated durable efficacy and safety results across multiple RA
patient populations, including in people with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more
biologic treatments and those who were MTX treatment-naïve. Safety results were consistent across the trials and further reinforce the long-term
safety and tolerability profile of filgotinib for a broad range of RA patients. Despite the availability of current therapies, people living with RA may
face persistent disease symptoms and inadequate responses to currently available therapies. One in five patients do not achieve complete disease
remission during their lifetimes and remain in need of treatment options.This filing is the third regulatory agency submission for filgotinib in the
past five months following submissions to the European Medicines Agency and Japanese Ministry of Health, Labor and Welfare earlier this year.

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Grifols (Spain) launches XEMBIFY® (immune globulin subcutaneous human-klhw)
20%, a new Primary Immunodeficiency treatment
42
Grifols, a leading global producer of plasma-derived medicines, announced the launch of its latest immunoglobulin (IG) innovation,
XEMBIFY®, the company’s first 20% subcutaneous immunoglobulin therapy for the treatment of patients 2 years of age and older with
primary immunodeficiency (PI). With proven safety, efficacy, and tolerability, XEMBIFY® offers subcutaneous administration to
patients in the treatment of PI, which are rare and chronic genetic disorders that occur in people born with an impaired or absent immune
system. There are roughly 150,0001 patients with PI who may be appropriate for IG therapy. Strengthening Grifols’ growing IG portfolio
for PI treatment, XEMBIFY® features a balanced formulation for the treatment of a wide range of PI patients, inclusive of those with risk
factors, such as diabetes or cardiac impairment. XEMBIFY® was approved by the U.S. Food and Drug Administration (FDA) in July
2019. With maximum immunoglobulin G (IgG) potency and purity due to the unique caprylate/chromatography process, XEMBIFY®
provides a customizable IG treatment option (from weekly to daily) that offers patients reliable protection from infections.

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Illumina (USA) Announces New Sequencing System, Partnership with Roche and
Software Suite to Accelerate Adoption of Genomics
43
Illumina, Inc. further demonstrated its commitment to making genomics more accessible for the potential benefit of patients with a series of technology
and partnership announcements that further the company’s commitment to unlocking the power of the genome.To support the growing demand for
clinical grade genomic information at lower cost, Illumina announced the NextSeq™ 1000 and NextSeq 2000 Sequencing Systems offering
breakthrough system design, chemistry innovations and on-instrument integrated informatics for rapid secondary analysis. The new systems
incorporate more than 75 innovations, including the never before commercialized combination of super resolution and blue chemistry, that enables a
substantial increase in density and throughput as well as a reduction in operating costs.Illumina also announced the development of a regulatory-cleared
version of the high-throughput NovaSeq system to address growing demand for a Dx platform to support deeper sequencing at higher throughput.
NovaSeqDx extends the company’s portfolio of Dx cleared systems and, ahead of commercial availability targeted for 2022, will be available to IVD
partners, including Roche, for content development.Turn-key data analysis solutions also have the ability to facilitate and accelerate clinical adoption.
TruSight Software Suite v1.0 delivers ready-made infrastructure to adopt, ramp and realize the full potential of genome sequencing in rare and
undiagnosed genetic disease. TruSight Software enables sample-to-report for genetic disease making it easier to access the valuable insights enabled by
sequencing with comprehensive variant class analysis for greatest diagnostic yield.

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LabCorp (USA) and Covance Connect Sponsors with Patients Virtually
with an Expanded Suite of Decentralized Trial Solutions
44
LabCorp®, a leading global life sciences company that is deeply integrated in guiding patient care, unveiled its latest solution for decentralized clinical trials
from Covance to help transform the conduct of hybrid and virtual trials.Covance’s cohesive hybrid and virtual clinical trials solution integrates unique
capabilities from across Covance and LabCorp, 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 (PSC), including 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.This
decentralized clinical trials offering is underpinned by highly diverse, global data that enables faster identification of potential candidates for a trial. The
solution seamlessly integrates Covance central laboratories, LabCorp specialty diagnostic laboratories, direct-to-patient market access call centers, and a
suite of technology solutions to bring the trial closer to the patient, and streamline trial execution.The Covance decentralized trials offering is powered by a
suite of integrated, modular, and highly configurable technology solutions that can be customized to deliver any conforming study protocol. The technology
platform supports end-to-end delivery of hybrid and virtual clinical trials by enabling data interoperability and seamless data collection. The platform also
can integrate connected devices, wearables and other mobile health, also known as mHealth, technologies to capture primary and secondary endpoint data
across multiple indications and connect patients, investigators and decentralized sites.

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LabCorp (USA) and Covance Launch Extensive Preclinical, Clinical and
Post-Approval Cell and Gene Therapy Development Solutions
45
LabCorp®, a leading global life sciences company that is deeply integrated in guiding patient care, introduced its focused and coordinated
suite of cell and gene therapy development solutions from Covance, its drug development business. These solutions are designed to reduce
time and risk for sponsors at each phase and across the full continuum of their therapy development needs in one of the industry’s
fastest-growing segments. With more than 20 years of experience in delivering development solutions for advanced therapies, such as cell and
gene therapy products, Covance provides a unique offering of specialized expertise and coordinated capabilities, combined with focused
investments supporting the preclinical, clinical and post-approval phases of development. By offering a coordinated approach to scientific and
program consultation, biomarker and companion diagnostic development, study management, regulatory and commercialization support
capabilities, Covance is uniquely positioned to partner with sponsor organizations to address complexity, reduce cost and risk, and effectively
accelerate timelines of their novel therapies.Cell and gene therapies, which fit into the general category of advanced therapy medicinal
products, are more complex and specialized than traditional drugs. They can involve correcting or replacing genetic information and
engineering the correct functionality of cells or genes for many conditions, including cancer and rare diseases with a genetic basis.

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Medtronic (Ireland) Expands Surgical Synergy(SM) with FDA Clearance
of the Stealth Autoguide™ System for Cranial Procedures
46
Medtronic plc announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform
that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is a robotic guidance
system intended for the spatial positioning and orientation of instrument holders or tool guides used in neurosurgical procedures. The Stealth Autoguide Platform
is cleared for biopsy procedures, stereoelectroencephalography (sEEG) depth electrode placement, and for the positioning of the Visualase™ bone anchor, which
is used for catheter placement. These solutions are part of the company’s market-leading Surgical Synergy platform, which integrates Medtronic technologies to
create consistent, predictable, and reproducible procedures.Stealth Autoguide system integrates with StealthStation™ Image Guidance systems and the Midas Rex
™ high-speed surgical drill platform. The navigation software optimizes the surgical workflow, providing continuous real-time navigation and visual feedback on
the robotic alignment for improved efficiency. The system provides visualization throughout the entire procedure, even while drilling, with the ability to drill on
the axis of a surgical plan.Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and
solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people
worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.

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Medtronic (Ireland) Receives CE Mark Approval for the Percept™ PC
Neurostimulator DBS System with BrainSense™ Technology
47
Medtronic plc announced the CE Mark for Percept™ PC neurostimulator; it is the only Deep Brain Stimulation (DBS) system to be launched in the European
Union (EU) with BrainSense™ technology that can sense and record brain signals while delivering therapy to patients with neurologic disorders, such as
Parkinson’s disease. BrainSense technology enables physicians to track patient-specific brain signals and correlate these with patient-recorded events, such as
symptoms or side-effects associated with their disease or the medications to treat it. This enables more personalized, data-driven neurostimulation treatment. The
Percept PC neurostimulator is approved in the EU for the treatment of symptoms associated with Parkinson’s disease (PD), essential tremor, primary dystonia as
well as epilepsy and obsessive-compulsive disorder (OCD). It is currently under review by the U.S. Food and Drug Administration.
In addition to BrainSense technology, the Percept PC DBS system features several leading-edge innovations, including:
• The only DBS system with MR conditional labeling that allows for 3T and 1.5T full-body MRI scans, providing patients access to cutting-edge medical imaging
• Improved battery longevity compared to Medtronic’s Activa™ PC neurostimulator (when using similar settings and functionality) in a smaller (reduced volume),
ergonomic design for patient comfort
• Low pulse width (duration of the pulse), providing expanded stimulation options allowing for finer control over the neural activation area
• Enhanced Patient Programmer leveraging a user-friendly, custom-configured Samsung mobile device that allows patients to manage their therapy easily
• Designed to easily facilitate expanded capabilities in the future via software upgrades – to prepare for what’s next in DBS

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Medtronic (Ireland) Receives CE Mark for InterStim™ Micro Neurostimulator
and InterStim™ SureScan™ MRI Leads
48
Medtronic plc announced it has received CE Mark for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads — clearing the technologies
for commercial sale and clinical use in Europe. The availability of the new technologies on January 15 will expand access to sacral neuromodulation (SNM)
therapy for thousands of potential European patients by offering full-body MRI scan eligible, lifestyle-friendly choices with either the InterStim Micro or InterStim
II neurostimulators. InterStim Micro is a rechargeable device that delivers sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence
(FI) and non-obstructive urinary retention. It is 80% smaller than the existing recharge-free InterStim II neurostimulator and could reduce the need for battery
replacement surgeries due to its life of 15 years. It also features proprietary Overdrive™ battery technology — a battery with virtually no loss in capacity over
time1 — that provides simple and rapid recharging. The SureScan leads, which will be used in both the InterStim Micro system and in future implants of the
existing recharge-free InterStim II, are designed to allow for full-body 1.5 and 3 Tesla MRI-conditional scans. Between 4% and 8% of the world’s population —
almost 400 million people worldwide2 — suffer from incontinence. In addition, at least half of patients with pacemakers or neurostimulators will have a clinical
indication for an MRI examination over their lifetime3, and up to 23% of SNM explants are currently due to the need for an MRI scan4. Medtronic has treated
more than 300,000 patients with recharge-free InterStim systems and, now, the rechargeable InterStim Micro and SureScan leads for the InterStim Micro and
InterStim II systems will allow even more patients to access the therapy. In addition, Medtronic is the only company in Europe to offer patients a choice between
rechargeable and recharge-free systems that are both full-body MRI-conditional.

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Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across
Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer
49
Merck known as MSD outside the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received new
approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in advanced renal cell carcinoma (RCC) and head and
neck cancer for the following additional indications in Japan:
• KEYTRUDA in combination with Inlyta (axitinib) for the first-line treatment of patients with radically unresectable or metastatic RCC;
• KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with recurrent or distant metastatic head and
neck cancer; and
• KEYTRUDA monotherapy for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer.
The approval for KEYTRUDA in combination with axitinib for radically unresectable or metastatic RCC is based on results from the
KEYNOTE-426 trial, in which KEYTRUDA in combination with axitinib demonstrated statistically significant improvements in the dual
primary endpoints of overall survival (OS) (HR=0.53 [95% CI, 0.38-0.74]; p=0.00005) and progression-free survival (PFS) (HR=0.69
[95% CI, 0.56-0.84]; p=0.00012) compared to sunitinib monotherapy.

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Merck (USA) Announces FDAApproval for ERVEBO® (Ebola Zaire
Vaccine, Live)
50
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved
ERVEBO® for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The duration of protection
conferred by ERVEBO is unknown. ERVEBO does not protect against other species of Ebolavirus or Marburgvirus. Effectiveness of the
vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown.
Do not administer ERVEBO to individuals with a history of a severe allergic reaction to any component of the vaccine, including rice
protein.As previously announced, Merck is working to initiate manufacturing of licensed doses and expects these doses to start becoming
available in approximately the third quarter of 2020. Merck is working closely with the U.S. government, WHO, UNICEF, and Gavi (the
Vaccine Alliance) to plan for how eventual, licensed doses will support future public health preparedness and response efforts against Zaire
ebolavirus disease.During this transition period, Merck continues to work urgently with its partners to ensure uninterrupted access to the
investigational Ebola Zaire vaccine (V920) in support of ongoing international response efforts in the Democratic Republic of the Congo and
neighboring countries. Merck has, to date, shipped more than 275,000 1.0mL doses of V920 based on requests by the WHO.

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