This document brings together a set
of latest data points and publicly
available information relevant for
Healthcare Industry. We are very
excited to share this content and
believe that readers will benefit from
this periodic publication immensely.
Narayana Hrudayalaya (NH) was incorporated by renowned cardiac surgeon Dr. Devi Prasad Shetty in 2000. The company was started as a predominant cardiac care hospitals group initially. Gradually, it also diversified into other specialties although cardiac still remains the mainstream specialty. NH operates a network of hospitals, diagnostic centers, clinical or test centers. It offers medical, surgery and diagnostics and supports services.
This document brings together a set
of latest data points and publicly
available information relevant for
Healthcare Industry. We are very
excited to share this content and
believe that readers will benefit from
this periodic publication immensely.
These slides provide an overview of a white paper - “Connecting with Patients, Overcoming Uncertainty” white paper was produced by Envision Solutions, TNS Media Intelligence/Cymfony and law firm Seyfarth Shaw.
Most fastest growing pharmaceutical companies in 2021Swiftnlift
Over the past two decades, the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centres, and the medical profession itself.
How to Manage Population Health Effectively in Accountable Care OrganizationsPhytel
The Affordable Care Act authorized a Medicare shared-savings program for accountable care organizations, and private payers are also contracting with ACOs. To succeed, ACOs must learn how to manage population health effectively.
This document brings together a set of latest data points and publicly available information relevant for Healthcare Industry. We are very excited to share this content and believe that readers will benefit immensely from this periodic publication immensely.
This document brings together a set
of latest data points and publicly
available information relevant for
Healthcare Industry. We are very
excited to share this content and
believe that readers will benefit from this periodic publication immensely.
Narayana Hrudayalaya (NH) was incorporated by renowned cardiac surgeon Dr. Devi Prasad Shetty in 2000. The company was started as a predominant cardiac care hospitals group initially. Gradually, it also diversified into other specialties although cardiac still remains the mainstream specialty. NH operates a network of hospitals, diagnostic centers, clinical or test centers. It offers medical, surgery and diagnostics and supports services.
This document brings together a set
of latest data points and publicly
available information relevant for
Healthcare Industry. We are very
excited to share this content and
believe that readers will benefit from
this periodic publication immensely.
These slides provide an overview of a white paper - “Connecting with Patients, Overcoming Uncertainty” white paper was produced by Envision Solutions, TNS Media Intelligence/Cymfony and law firm Seyfarth Shaw.
Most fastest growing pharmaceutical companies in 2021Swiftnlift
Over the past two decades, the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centres, and the medical profession itself.
How to Manage Population Health Effectively in Accountable Care OrganizationsPhytel
The Affordable Care Act authorized a Medicare shared-savings program for accountable care organizations, and private payers are also contracting with ACOs. To succeed, ACOs must learn how to manage population health effectively.
This document brings together a set of latest data points and publicly available information relevant for Healthcare Industry. We are very excited to share this content and believe that readers will benefit immensely from this periodic publication immensely.
This document brings together a set
of latest data points and publicly
available information relevant for
Healthcare Industry. We are very
excited to share this content and
believe that readers will benefit from this periodic publication immensely.
This document brings together a set of latest data points and publicly available information relevant for Healthcare Industry. We are very excited to share this content and believe that readers will benefit from this periodic publication immensely.
This document brings together a set of latest data points and publicly available information relevant for Healthcare Industry. We are very excited to share this content and believe that readers will benefit from this periodic publication immensely.
ACOs: Four Ways Technology Contributes to SuccessHealth Catalyst
With an increasing emphasis on value-based care, Accountable Care Organizations (ACOs) are here to stay. In an ACO, healthcare providers and hospitals come together with the shared goals of reducing costs and increasing patient satisfaction by providing high-quality coordinated healthcare to Medicare patients. However, many ACOs lack direction and experience difficulty understanding how to use data to improve care. Implementing a robust data analytics system to automate the process of data gathering and analysis as well as aligning data with ACO quality reporting measures. The article walks through four keys to effectively implementing technology for ACO success:
Build a data repository with an analytics platform.
Bring data to the point of care.
Analyze claims data, identify outliers, including successes and failures.
Combine clinical claims, and quality data to identify opportunities for improvement.
Catasys, Inc. harnesses proprietary big data predictive analytics, artificial intelligence and telehealth, combined with human intervention, to deliver improved member health and cost savings to health plans through integrated technology enabled treatment solutions. It is our mission to provide access to affordable and effective care, thereby improving health and reducing cost of care for people who suffer from the medical consequences of behavioral health conditions; helping these people and their families achieve and maintain better lives
The Healthcare Revenue Cycle: How to Optimize PerformanceHealth Catalyst
Health systems rely on effective revenue cycle management to follow the patient journey, navigate claims, and ensure the organization collects payment for its services. In today’s complex and fluid healthcare industry, in which revenue cycle management is about much more than billing and collecting payment, traditional revenue cycle approaches can’t meet escalating demands. Additionally, with lost volume due to COVID-19, organizations can’t afford to miss an opportunity for payment.
The contemporary healthcare landscape requires a comprehensive, standardized, and data-driven revenue cycle process. Health systems that leverage data to support revenue cycle management improve their financial outcomes in three significant ways:
1. Reduce denials.
2. Increase collections with propensity-to-pay insight.
3. Improve discharged-not-final-billed efforts.
White Paper - Building Your ACO and Healthcare IT’s RoleNextGen Healthcare
The tools needed to capture, organize, and share healthcare data are truly evolving at the speed of light. Patient Centered Medical Homes play a vital role in the path toward accountable care and technology, staff, and workflow transformation are necessary to achieve PCMH recognition. This transformation allows healthcare providers to deliver higher quality coordinated care by streamlining and rationalizing the patient experience.
Health Systems Share COVID-19 Financial Recovery Strategies in First Client H...Health Catalyst
More than 100 attendees joined the first of a series of Health Catalyst virtual client huddles designed to support client partners and aid collaboration and direct client connections in this time of unprecedented change. According to an April 2020 survey of Health Catalyst clients, 72.6 percent said they had a strong interest in examples, guidance, and tools from other health systems. In the client-only session, insights shared included the most common COVID-19 analytic projects and one health system’s elective surgery plan.
The health system shared the challenges they faced in understanding the financial impact of halting elective surgeries as well as creating a plan for working through their backlog. They also shared the tools and strategies they are using to aid their financial recovery.
This document brings together a set
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Consulting & IT Services Industry.
We are very excited to share this
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This document brings together a set
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Agile & AI Operations Industry. We
are very excited to share this content
and believe that readers will benefit
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immensely.
T-Byte Hybrid Cloud Infrastructure July 2021EGBG Services
This document brings together a set
of latest data points and publicly
available information relevant for
Hybrid Cloud Infrastructure
Industry. We are very excited to share
this content and believe that readers
will benefit from this periodic
publication immensely.
This document brings together a set
of latest data points and publicly
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Platforms & Applications Industry.
We are very excited to share this
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immensely.
T-Byte Digital Customer Experience July 2021EGBG Services
This document brings together a set
of latest data points and publicly
available information relevant for
Digital Customer Experience
Industry. We are very excited to share
this content and believe that readers
will benefit from this periodic
publication immensely
This document brings together a set
of latest data points and publicly
available information relevant for
IoT & AR Services Industry. We are
very excited to share this content and
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this periodic publication immensely.
This document brings together a set
of latest data points and publicly
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Banking Industry. We are very
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This document brings together a set
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Manufacturing Industry. We are very
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This document brings together a set
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Hospitality Industry. We are very
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This document brings together a set
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Automotive Industry. We are very
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This document brings together a set
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Healthcare Industry. We are very
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This document brings together a set
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Resources Industry. We are very
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Utilities Industry. We are very
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Business Services Industry. We are
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This document brings together a set
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Telecommunication & Media
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This document brings together a set
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Travel & Transportation Industry. We
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Technology Industry. We are very
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This document brings together a set
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Energy Industry. We are very excited
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This document brings together a set
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Retail & Consumer Goods Industry.
We are very excited to share this
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ITShades.com has been founded with
the singular aim of engaging and
enabling the best and brightest of
businesses, professionals and
students with opportunities,
learnings, best practices,
collaboration and innovation from IT
industry.
This document brings together a set
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Insurance Industry. We are very
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The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
This document is designed as an introductory to medical students,nursing students,midwives or other healthcare trainees to improve their understanding about how health system in Sri Lanka cares children health.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Letter to MREC - application to conduct studyAzreen Aj
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
Our mission is to provide a safe and supportive environment where our clients can receive the highest quality of care. We are dedicated to assisting our clients in reaching their objectives and improving their overall well-being. We prioritize our clients' needs and individualize treatment plans to ensure they receive tailored care. Our approach is rooted in evidence-based practices proven effective in treating addiction and mental health disorders.
karnapuran PPT made by Dr nishant very easy to understand how karanapuran is ...
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I-Bytes
Healthcare
January Edition 2021
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About Us
Who We are Aim of this IByte Reasons to talk to us
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Table of Contents
1. Financial, M & A Updates..................................................................................................................................1
2. Solution Updates................................................................................................................................................11
3. Customer Success Updates...............................................................................................................................35
4. Partnership Ecosystem Updates......................................................................................................................36
5. Environment & Social Updates.......................................................................................................................45
6. Miscellaneous Updates.....................................................................................................................................48
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Financial, M & A
Updates Healthcare Industry
6. Financial, M&A Updates
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Boston Scientific (USA) Announces Preliminary Unaudited Sales For
The Fourth Quarter And Full Year 2020
Fourth quarter preliminary financial results and recent developments:
1. Delivered the following fourth quarter sales growth/(declines) in each reportable segment3 compared to the prior year period:
• MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
• Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
• Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic
2. Accelerated sequential organic growth in the Peripheral Interventions business (4.8 percent organic growth), including 12 percent growth within the Interventional Medicine3
portfolio.
3. Returned to growth in the MedSurg reportable segment3 (1.1 percent organic growth) in the fourth quarter, driven by recovering procedural trends and favorable site of service
mix. This includes a broad-based recovery in the Endoscopy business (1.5 percent organic growth), and growth within the stone and benign prostatic hyperplasia (BPH) franchises
in Urology and Pelvic Health (0.6 percent organic growth).
4. WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device portfolio experienced strong customer demand in the fourth quarter. Organic sales
declined 56 percent, which includes a negative 74 percent impact due to the conversion to a consignment inventory model and transition discussed above, and surpassed 150,000
cumulative implants worldwide.
5. Achieved key milestones for the Neuromodulation business with the WaveWriter Alpha™ portfolio of Spinal Cord Stimulator (SCS) systems including recent U.S. Food and Drug
Administration (FDA) approval and third quarter 2020 launch in Europe.
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1
Key Financial Highlights
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Bristol Myers Squibb Announces $2 Billion Incremental Share Repurchase
Authorization
Bristol Myers Squibb announced that its Board of Directors has authorized incremental share repurchases of up to an
additional $2 billion of the company’s outstanding shares of common stock. With this increase, the company’s total
outstanding share repurchase is approximately $6.4 billion. The timing and amount of any share repurchases under the
authorization will be determined by management at its discretion and based on market conditions and other
considerations. Share repurchases under the authorizations may be made through a variety of methods, which may
include open market purchases, pursuant to pre-set trading plans meeting the requirements of Rule 10b-1 under the
Securities Exchange Act of 1934, in privately negotiated transactions, block trades, accelerated share repurchase
transactions, or any combination of such methods. The program does not obligate Bristol Myers Squibb to acquire any
particular amount of its common stock, and the repurchase program may be suspended or discontinued at any time at the
Company’s discretion.
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Centene (USA)Signs Definitive Agreement to Acquire Magellan Health
Centene Corporation and Magellan Health, Inc. announced that they have entered into a definitive
merger agreement under which Centene will acquire Magellan Health for $95 per share in cash for a
total enterprise value of $2.2 billion. The transaction, which was unanimously approved by the Boards
of Directors of both companies, will broaden and deepen Centene's whole health capabilities and
establish a leading behavioral health platform. The combined platform lays the foundation by which
the company will continue to invest and innovate for its members, enabling improved health outcomes
and faster, diversified growth. The combination brings together the companies' complementary
capabilities in behavioral health, specialty healthcare and pharmacy management. As a result of the
transaction, Centene will establish one of the nation's largest behavioral health platforms across 41
million unique members with enhanced capabilities to deliver better health outcomes for complex,
high-cost populations. Magellan Health will also add to Centene's leadership in government sponsored
healthcare, bringing 5.5 million new members on government-sponsored plans. Magellan Health also
provides specialty health services for 18 million third-party customer members in addition to
Centene's own members. Furthermore, the transaction adds 2 million PBM members and 16 million
medical pharmacy members, enhancing the scale of Centene's pharmacy platform with leading
capabilities in specialty drug management. As part of Centene's Health Care Enterprises, Magellan
Health will continue to independently support its existing customers and pursue growth opportunities.
In addition, the transaction will create attractive shareholder returns through enhanced service
capabilities, cross-sell opportunities and increased engagement with third-party customers.
Executive Commentary
"There is a critical need for a fundamentally better approach to supporting people with complex,
chronic conditions through better integration of physical and mental health care. This has become
even more evident in light of the pandemic which has driven a dramatic rise in behavioral health
needs," said Chairman, President and Chief Executive Officer of Centene. "This acquisition
accelerates our diversification strategy and enhances our ability to build next generation
capabilities in our specialty care business by leveraging our scale and investments in technology.
Furthermore, we are very familiar with the range of Magellan Health's healthcare solutions as we
have been one of their customers over many years, and our shared commitment to taking care of
the most vulnerable populations makes this transaction a natural step."
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Cigna Institutes(USA) Quarterly Cash Dividend and Declares First Quarterly
Dividend; Announces Investor Day on March 8, 2021
Global health services company Cigna Corporation announced that its Board of
Directors has instituted a quarterly cash dividend and declared the first quarterly cash
dividend of $1.00 per share of Cigna common stock to be paid on March 25, 2021 to
shareholders of record as of the close of trading on March 10, 2021. Cigna intends to
pay regular quarterly dividends, with future declarations subject to approval by its
Board of Directors and the Board's determination that the declaration of dividends
remains in the best interests of Cigna and its shareholders. The decision of whether
to pay future dividends and the amount of any such dividends will be based on the
Company's financial position, results of operations, cash flows, capital requirements,
the requirements of applicable law and any other factors the Board of Directors may
deem relevant. As of December 31, 2020, Cigna's outstanding share repurchase
authority as approved by Cigna's Board of Directors was approximately $3.9 billion.
Cigna expects to deploy at least $2 billion to share repurchase during the first quarter
of 2021.1 From November 5, 2020, when Cigna reported third quarter 2020 earnings,
through December 31, 2020, Cigna repurchased 5.9 million shares of common stock
for approximately $1.2 billion.
Executive Commentary
"Cigna has a long track record of effective capital deployment, and our initiation
of a quarterly dividend demonstrates our confidence in our ongoing ability to
drive growth as we meet the needs of those we serve," said, president and chief
executive officer. "We are excited to share more at our Investor Day on March 8,
2021 about the strategic positioning of our businesses, drivers of ongoing,
differentiated growth, and strong operating cash flow generation, which position
us to deliver attractive shareholder returns."
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New York Life Completes Acquisition of Cigna's (USA) Group Life and Disability
Insurance Business
New York Life, America's largest mutual life insurer announced the completion of
the company’s acquisition of Cigna’s group life, accident, and disability insurance
business. The $6.3 billion acquisition, which was first announced on December
18, 2019, adds approximately 3,000 employees, over nine million customers[2],
and enhances New York Life’s portfolio of strategic businesses, which support the
core retail life insurance franchise and bolster the company’s financial strength.
The new business will be rebranded New York Life Group Benefit Solutions.
New York Life and Cigna have also entered into a multi-year collaboration that
will continue to bring differentiated, integrated health and group benefit solutions
for clients and prospects who desire them.New York Life Group Benefit Solutions
will operate within New York Life’s portfolio of strategic businesses, which
includes Group Membership Association, Institutional Annuities, Institutional
Life, New York Life Direct, and Seguros Monterrey New York Life, among
others. With the completion of the acquisition, New York Life is now a top five
insurer across group life, accident, and disability insurance.
Executive Commentary
New York Life President added, “Industry-leading New York Life Group
Benefit Solutions is an ideal fit for our company, with a strong management
team and talented workforce. We look forward to adding New York Life
Group Benefit Solutions’ complementary suite of benefits and services to our
offerings and growing together in the future. With this acquisition, New York
Life is even more strongly positioned to continue to deliver financial security
to individuals, families, and business owners.”
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AstraZeneca (UK): Atacand divestment to Cheplapharm in more than 70
countries completed
AstraZeneca has completed the divestment of commercial rights to Atacand and Atacand Plus in over 70 countries to Cheplapharm Arzneimittel GmbH (Cheplapharm).
Financial considerations
Under the terms of the agreement AstraZeneca received a payment of $250m from Cheplapharm. AstraZeneca will receive further non-contingent payments equal to $150m during the first half of
2021. The present value of all payments, totalling $400m, will be reported in AstraZeneca’s financial statements within Other Operating Income in the fourth quarter of 2020. Pursuant to London
Stock Exchange listing rule 10.4.1R (notification of class 2 transactions), in 2019 Atacand and Atacand Plus generated product sales of $148m and profit before tax of $89m in the countries covered
by the agreement. The gross book value of assets subject to the divestment at 31 December 2019 was $nil. The consideration was and will be paid in cash, and the proceeds used for general corporate
purposes.
Atacand
Atacand (candesartan cilexetil) is a selective AT1 subtype angiotensin II receptor antagonist that is indicated for the management of hypertension in adults and children/adolescents, as well as heart
failure in adults. Atacand Plus is indicated for the management of hypertension when candesartan or hydrochlorothiazide monotherapy is not sufficiently effective. Atacand was developed in
collaboration with Takeda Pharmaceutical Company Limited. Each company held the exclusive rights to the medicine in certain countries; in other countries, Atacand was co-marketed.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases
in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
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abbvie (USA): Allergan Aesthetics Enters Into Option to Acquire Cypris Medical
Allergan Aesthetics, an AbbVie company announced that it has
entered into a warrant agreement with Cypris Medical, a privately
held, medical device company based in Chicago. Following the
completion of a clinical trial to be initiated in 2021, Allergan
Aesthetics will have the right to exercise an option to acquire Cypris
Medical, including the company's Xact device. The planned clinical
trial will evaluate the safety and effectiveness of Xact in treating
midface descent as well as for neck lifts. Replacing the scalpel, Xact is
designed to allow for lifting and suturing of the superficial muscular
aponeurotic system (SMAS), the same tissue mobilized in a facelift,
but in a minimally-invasive manner. The innovative technology
intends to provide patients surgery-like results in the office with little
to no downtime.
Executive Commentary
"As a global leader in aesthetics, we are proud to support the
research of an innovative device that complements our iconic
portfolio of non-invasive treatment options like Botox Cosmetic
and our Juvéderm Collection of Fillers," says Carrie Strom, SVP
AbbVie and President, Global Allergan Aesthetics. "We know there
is continued unmet need for minimally-invasive procedures for
midface descent, and Xact affords us the ability to create a new
alternative for our customers so they can continue to offer
leading-edge treatments to patients."
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13. Financial, M&A Updates
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Gilead (USA) Sciences Announces Updated 2020 Guidance
The following provides additional details on the company’s updated guidance:
• Gilead delivered solid performance, despite the global impacts of COVID-19.
• Total product sales guidance range is now $24.30 billion to $24.35 billion, reflecting increased Veklury® sales as hospitalization and treatment rates were higher than
expected given the most recent COVID-19 surge.
• As a reminder, full year 2020 total product sales excluding Veklury reflects the underlying strong Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg) uptake, partially offset by the Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) loss of exclusivity in the United States and the
impact of COVID-19 primarily on Gilead’s pre-exposure prophylaxis franchise and chronic hepatitis C virus franchise.
• Guidance for Research and development expense changed to reflect the increase in expense for obligations under the previously disclosed new commercialization and
development agreement for Jyseleca® with Galapagos NV. In addition, R&D expense for the full year 2020 reflects growth due to higher clinical trial and manufacturing
ramp-up expenses related to Gilead’s COVID-19 treatment remdesivir.
• Selling, general and administrative expense reflects the low-end of Gilead’s previous guidance. As a reminder, SG&A expense grew for the full year 2020 due to a legal
accrual related to a previously disclosed legal settlement, expenses associated with the acquisitions of Forty Seven, Inc. and Immunomedics, Inc., and certain remdesivir
donations.
• GAAP Diluted EPS guidance is ($0.08) to $0.02 and Non-GAAP Diluted EPS guidance is $6.98 to $7.08 for full year 2020.
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Key Financial Highlights
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Henry Schein (USA) Acquires Majority Interest in Prism Medical Products, Enters
Home Medical Supply Market
Henry Schein, Inc, the world’s largest provider of health care solutions to
office-based dental and medical practitioners, announced the acquisition of a
majority ownership position in Prism Medical Products, LLC (PRISM), a nationwide
provider of specialty home medical supplies with a core competency in advanced
wound care products. With this transaction, Henry Schein Medical, the U.S. medical
division of Henry Schein, Inc., enters an established and growing multibillion-dollar
market for home medical equipment and supplies. PRISM is a privately held
company founded in 2006 with headquarters in Elkin, North Carolina, as well as an
operations office in Las Vegas, Nevada, and 10 fulfillment centers located across the
U.S. The company has more than 200 team members and had net revenue for the 12
months ended September 30, 2020, of approximately $52 million. PRISM is
expected to be neutral to Henry Schein's 2021 earnings per diluted share and
accretive thereafter. Financial terms were not disclosed. PRISM will operate as a
subsidiary of Henry Schein Medical and will be managed separately as an individual
division by Chris Cartwright, Founder and President of Prism Medical Products.
Executive Commentary
“Expanding beyond our core base of office-based physicians and entering the
home health market has been a long-standing strategic goal of Henry Schein’s
medical business, and with PRISM we have the ideal partner with a strong brand
and a complementary business model,” said Chairman of the Board and Chief
Executive Officer of Henry Schein. “This partnership expands Henry Schein
Medical’s continuum-of-care delivery model and allows us to move closer and to
interact directly with patients. It also strengthens our relationships with the
physicians who prescribe home medical supplies. Importantly, PRISM and its
management team is tightly aligned with Henry Schein’s strategy and culture,
and we look forward to a smooth integration of this business. We welcome our
new colleagues to Team Schein and look forward to continued success together.”
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Walgreens Boots Alliance Makes a Majority Investment into iA to Advance
Automation Capabilities for the Pharmacy Industry
Walgreens Boots Alliance and iA announced that WBA has made a
majority investment in iA, a leading-edge provider of software enabled
automation solutions for retail, hospital, federal healthcare and mail-order
pharmacy markets. WBA’s investment will support iA’s expansion and
further development of pharmacy automation solutions to benefit the entire
pharmacy industry. For millions of Americans, the pharmacist is an
essential partner in ensuring their health and quality of life. The COVID-19
pandemic has created an even greater sense of urgency for patients and
customers to have direct access to pharmacists to receive trusted care and
advice in order to take care of their families. iA’s pharmacy automation
solutions enable the shifting of much of the current medication dispensing
labor that takes place in a retail pharmacy to more efficient, centralized
settings, therefore freeing up more time for pharmacists to deliver front-line
patient care.
Executive Commentary
“The role of pharmacists as an integral part of the healthcare system and
patients’ care teams has never been more critical,” said executive vice
chairman and CEO, Walgreens Boots Alliance. “The iA mission to
further modernize and automate the prescription fulfillment process
aligns with our priority to create the pharmacy of the future, reducing
operational costs and enabling pharmacists to spend more time
providing valuable healthcare services to patients such as vaccinations,
diagnostic testing and medication management.”
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Healthcare Industry
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Astellas Pharma (Japan): FDAAccepts for Priority Review the New Drug Application for mirabegron for Oral
Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients
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Solution Description
Astellas Pharma Inc. announced that the U.S. Food and Drug Administration accepted priority review for its New Drug
Application for mirabegron for oral suspension and its supplemental New Drug Application for Myrbetriq® tablets for the
treatment of neurogenic detrusor overactivity in pediatric patients aged three years and older. The Prescription Drug User Fee
Act goal date for a decision by the FDA is March 28, 2021. NDO is a neurological bladder dysfunction caused by nerve damage.
Children with NDO may experience involuntary bladder contractions, which can lead to symptoms of urinary urgency, frequency
and incontinence. 1 Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children. 2 The NDA and sNDA
were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of
mirabegron in children and adolescents (aged 3 to <18 years) with NDO and using clean intermittent catheterization
(ClinicalTrials.gov Identifier: NCT02751931). Myrbetriq® tablets were initially approved in 2012 in the United States for the
treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
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Astellas Pharma (Japan): Hold lifted by FDA on ASPIRO Clinical Trial of
AT132 for Treatment of X-Linked Myotubular Myopathy
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Solution Description
Astellas Pharma Inc. , President and CEO announced that its wholly owned subsidiary Audentes Therapeutics, Inc.
(“Audentes” ) has been notified that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold for the
ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM). XLMTM is a
serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and
early death. Astellas and Audentes are deeply committed to the continued safe development of AT132 for the families
and patients living with XLMTM, a disease with no existing treatments. Audentes is now working to complete all
clinical and regulatory activities necessary to resume dosing, and plans to have discussions at a future date with the
regulators on the path forward toward global registration filing for AT132.
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Lynparza approved in Japan for the treatment of advanced ovarian,
prostate and pancreatic cancers
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Solution Description
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers. The three approvals authorise
Lynparza for: maintenance treatment after 1st-line chemotherapy containing bevacizumab (genetical recombination) for patients with homologous recombination repair
deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castrate-resistant prostate cancer with distant metastasis (mCRPC); and as
maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer. The concurrent approvals by the Japanese
Ministry of Health, Labour, and Welfare are based on positive results from the PAOLA-1, PROfound and POLO Phase III trials, which each were published in The New England
Journal of Medicine.
Lynparza in ovarian cancer
The approval as 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer is based on a biomarker subgroup analysis of the
PAOLA-1 Phase III trial which showed Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS)
improvement versus bevacizumab alone, for patients with HRD-positive advanced ovarian cancer.
Lynparza in prostate cancer
The approval for the treatment of BRCAm mCRPC is based on a subgroup analysis of the PROfound Phase III trial which showed Lynparza demonstrated a substantial
improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. Lynparza is the
first and only PARP inhibitor approved in Japan in advanced prostate cancer.
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AstraZeneca’s COVID-19 vaccine authorised for emergency supply in the
UK
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Solution Description
AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released so that vaccinations may begin early in the New Year. The
UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for
the active immunisation of individuals 18 years or older. The authorisation recommends two doses administered with an interval of between four and 12 weeks. This regimen was
shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
AstraZeneca is working with Public Health England and National Health Service England to support the deployment and roll out of the vaccine in the UK, in line with the MHRA and
the UK’s Joint Committee on Vaccination and Immunisation dosing recommendation. The Company aims to supply millions of doses in the first quarter as part of an agreement with
the government to supply up to 100 million doses in total. The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which
enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. This is the first authorisation for this vaccine. The MHRA’s decision was
based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III programme led by
the University of Oxford. The data were also published in The Lancet on 8 December 2020. Additional safety and efficacy data for the vaccine will continue to accumulate from
ongoing clinical trials. AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional
marketing authorisation during the health crisis. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine
availability in low- and middle-income countries. AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine
globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/
36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
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Serum Institute of India obtains emergency use authorisation in India for
AstraZeneca’s COVID-19 vaccine
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Solution Description
AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and
Morocco for the active immunisation of adults. The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no
severe cases and no hospitalisations more than 14 days after the second dose. The approval in India is an important milestone as it will enable to supply India but
also a large number of countries around the world. AstraZeneca has partnered with Serum Institute of India (SII), the world's largest vaccine manufacturer, for the
supply of the vaccine to the Indian Government but also to a large number of low and middle-income countries. AstraZeneca has already submitted a substantial
data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling
review process and will continue to work closely with the EMA to seek approval in the coming weeks. AstraZeneca is also seeking Emergency Use Listing from
the World Health Organization for an accelerated pathway to vaccine availability in low-income countries during this health crisis and has ongoing rolling reviews
with many other regulatory authorities around the world. In addition to the University of Oxford-led trials, the Company is conducting a large trial in the US as
part of a global programme. In total, the University of Oxford and AstraZeneca expect to enrol more than 60,000 participants worldwide. Additional safety and
efficacy data will continue to accumulate from ongoing clinical trials. AstraZeneca is working with its global partners to continue building manufacturing capacity
of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at
normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
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Baxter BioPharma (USA) Solutions Announces Sterile Manufacturing
Agreement for Novavax COVID-19 Vaccine
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Solution Description
Baxter International Inc. a global leader in sterile medication production and delivery, announced that Baxter BioPharma Solutions has entered into an
agreement to provide sterile manufacturing services for NVX-CoV2373, Novavax’ COVID-19 recombinant nanoparticle vaccine candidate with Matrix-M
™ adjuvant. Baxter BioPharma Solutions is a premier contract manufacturing organization that specializes in parenteral (injectable) pharmaceuticals,
including vaccines. The agreement is expected to advance commercial-scale manufacturing essential for the vaccine’s production and distribution in the
United Kingdom and European markets. Novavax’ COVID-19 vaccine candidate is currently in phase 3 trials and has not yet been authorized or approved
for use. According to Novavax, NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology
and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S)
protein and is produced in insect cells. It can neither cause COVID-19 disease nor can it replicate, is stable at 2°C to 8°C and is manufactured in a
ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels. Baxter’s manufacturing services for NVX-CoV2373
will take place at its state-of-the-art facility in Halle/Westfalen, Germany. The site has broad sterile manufacturing capabilities and areas of focus, offers
current good manufacturing practices (cGMP) manufacturing with dedicated production areas and is designed to deliver products with optimum efficiency
and speed to market. Baxter’s recently expanded Halle/Westfalen facility has been in operation for more than 60 years.
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Biogen (USA) To Launch Pioneering Study To Develop Digital Biomarkers
Of Cognitive Health Using Apple Watch And Iphone
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Solution Description
Biogen Inc. announced a new virtual research study, in collaboration with Apple, to investigate the role Apple Watch and iPhone could play in
monitoring cognitive performance and screening for decline in cognitive health including mild cognitive impairment (MCI). The multi-year,
observational research study will be launched later in 2021 and will enroll participants including young and aging adults with a range of cognitive
performance. Driven by the powerful technology in Apple Watch and iPhone and Biogen’s in-depth knowledge of neuroscience, the study’s
primary objectives are to develop digital biomarkers to help monitor cognitive performance over time and identify early signs of MCI. For aging
adults, cognitive health is becoming increasingly recognized as an important component of overall health. However, significant delays exist in
identifying declines in cognitive health including MCI, which impacts approximately 15 – 20 percent of adults over the age of 65. The onset of
symptoms is often subtle, ranging from being easily distracted to memory loss, and can take months to years before cognitive decline comes to the
attention of health care providers. The virtual study allows adult users across the aging lifespan to join. The study has been designed with customer
privacy, control and transparency in mind as well as data security. Participants, who can stop taking part in the study at any time, will complete a
detailed consent form listing the collected data types and how each may be used and shared. Data will be stored in an encrypted manner and in
systems with strong security controls designed to protect the data.
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Cardinal Health (USA) launches TotalVue™ Analytics, a logistics
management tool powered by data to drive cost savings
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Solution Description
Cardinal Health company, announced the launch of TotalVue™ Analytics — a tool for healthcare supply chain leaders to utilize predictive
technology and data to identify logistics savings and benchmarking. Leveraging the scale of Cardinal Health, TotalVue™ Analytics provides health
systems with visibility into shipping trends to identify opportunities to reduce freight costs, including inbound shipments from suppliers or
outbound shipments from sites of care. With TotalVue™ Analytics, users can monitor comprehensive performance of a logistics management
program, including how small changes in shipping decisions can create continued savings. For example, TotalVue™ Analytics can identify cost
savings opportunities such as a supplier that is shipping too many packages overnight, or a location that is not using the program to get shipping
discounts. By reviewing consistent data points, health systems can set measurable goals and track performance. Management of shipping spend
across the health system is essential to identify maximum efficiencies, and visibility into critical logistics management metrics, which creates
material cost savings. Several customers participated in a pilot launch of TotalVue™ Analytics, including Mike Halmrast, senior director of
contracting at Banner Health, a non-profit health system based in Phoenix that operates 28 hospitals and several specialized facilities across six
states. According to Halmrast, the more inbound, outbound and large freight shipments the health system has under management, the more dollars
it can save to spend on patient care.
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DSM (Netherlands) and Clariter partner to pursue chemical recycling
solution for Dyneema®-based end-products
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Solution Description
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, and Clariter, an international clean-tech company, announced a strategic
partnership to pursue a next-generation chemical recycling solution for products based on DSM’s Dyneema®, an ultra-high-molecular-weight polyethylene
(UHMWPE) fiber. As a first step, sample products - including ropes, nets and ballistic materials made with Dyneema® - were successfully converted at Clariter’s
pilot plant in Poland, demonstrating the recyclability potential of Dyneema® and underlining the active commitment of DSM Protective Materials to shape a more
sustainable world. In line with its ambitious sustainability targets, and following the successful launch of bio-based Dyneema® (mass balance), DSM Protective
Materials is actively pursuing reuse and recycling solutions for end-of-life Dyneema®-based products. To drive technical recycling solutions, DSM Protective
Materials and Clariter partnered to test the feasibility of using Dyneema® as a feedstock in Clariter’s chemical recycling process. Sample products made with
Dyneema® were used in Clariter’s tests at its pilot plant in Poland. The positive results confirm the technical viability of transforming Dyneema®-based
end-products into high-value, industrial grade, product families: oils, waxes, and solvents via Clariter’s patented 3-step chemical recycling process. These can be
further used as ingredients to manufacture new end- and consumer products. Moving forward, DSM Protective Materials and Clariter will continue to drive this
initiative to shape a more sustainable world. Specifically, building on the success of the lab-scale trial, Clariter has scheduled commercial-scale trials at its facility
in South Africa for 2021, with the aim to use Dyneema®-derived feedstock in its full-scale European plants that will be built in the coming years. In addition, DSM
will continue to actively explore the possibilities of reducing the environmental impact of Dyneema® across all product life stages.
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DSM (Netherlands) and TU Delft establish artificial intelligence laboratory
to drive bioscience innovation
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Solution Description
Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, and TU Delft, ranked among the top universities in
biotechnology research globally, announce the establishment of the Artificial Intelligence Lab for Biosciences (the AI4B.io Lab). This
laboratory will be the first of its kind in Europe to apply artificial intelligence (AI) to full-scale biomanufacturing, from microbial strain
development to process optimization and scheduling. The AI4B.io Lab will be part of the Dutch National Innovation Center for AI (ICAI),
which works to keep the Netherlands at the forefront of knowledge and talent development in AI. It will be led by Professor Marcel Reinders,
Director TU Delft Bioengineering Institute. DSM regards biosciences as an important tool for addressing climate change and resource scarcity
and optimizing the global food system so will invest €2.5 million into the laboratory over the first five years. With more than 150 years of
experience, DSM has already developed an extensive portfolio of sustainable, bio-based solutions that help address some of the key
challenges facing society. Now, developments in the understanding of biology, as well as major advances in digital transformation, are
opening up exciting possibilities for new bio-based products, applications, and manufacturing processes. Integrating biosciences and digital
technologies can help to reduce the time spent on innovation cycles, from prototyping to scaling and commercialization.
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US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin)
for adults with heart failure with reduced ejection fraction
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Solution Description
The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Jardiance® which is being investigated as a potential new treatment
to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced
ejection fraction, including those with and without type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company announced. A high unmet need remains in the
treatment of heart failure, as approximately half of all those diagnosed are expected to die within five years. Heart failure is also the leading cause of hospitalization in
the U.S., with an estimated one million people being hospitalized due to the condition each year. The risk of death in people with heart failure rises with each hospital
admission. Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared
to a normally functioning heart. The sNDA is based on results from the EMPEROR-Reduced phase III trial, in which Jardiance was associated with a significant 25%
relative risk reduction in the primary composite endpoint of time to cardiovascular death or hospitalization due to heart failure. Additionally, the rate of decline in eGFR,
a measure of kidney function decline, was slower with Jardiance than with placebo, when both were given on top of standard of care treatment. Results were published
in The New England Journal of Medicine in August 2020. Initially approved in 2014, Jardiance is a once-daily tablet used along with diet and exercise to lower blood
sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is not for
people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). Jardiance is contraindicated in people with a history of
serious hypersensitivity reaction to empagliflozin or any of the excipients of Jardiance, and in people with severe renal impairment, end-stage renal disease, or dialysis.
Please see Important Safety Information below.
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Risankizumab (SKYRIZI) Demonstrates Significant Improvements in Clinical Remission and
Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease
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Solution Description
AbbVie announced positive results from two Phase 3 induction studies, ADVANCE and MOTIVATE, showing both doses of risankizumab met both primary endpoints of clinical
remission and endoscopic response at week 12 in adult patients with moderate to severe Crohn's disease.1,2 The ADVANCE study enrolled patients who had an inadequate response
or were intolerant to conventional and/or biologic therapy.1 The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.2In both
studies, clinical remission was measured by Crohn's Disease Activity Index and PRO-2 (two-component patient-reported outcome).1,2 In the ADVANCE study, a significantly greater
proportion of patients treated with risankizumab 600 mg or 1200 mg achieved clinical remission per CDAI at week 12 .1 Similar results were seen with clinical remission per PRO-2
.1 A significantly greater proportion of patients treated with either dose of risankizumab achieved endoscopic response at week 12 (40 and 32 percent of patients receiving risankizumab
600 mg or 1200 mg, respectively, versus 12 percent in the placebo group; p<0.001).1 In the MOTIVATE study, 42 and 41 percent of patients treated with risankizumab 600 mg or 1200
mg achieved clinical remission (per CDAI) at week 12, respectively, versus 19 percent of patients receiving placebo (p<0.001).2 A significantly greater proportion of patients in
MOTIVATE also achieved clinical remission (per PRO-2) (35 and 39 percent of risankizumab 600 mg or 1200 mg-treated patients, respectively, compared to 19 percent of patients
receiving placebo; p=0.001 for 600 mg; p<0.001 for 1200 mg).2 In addition, 29 and 34 percent of patients receiving risankizumab 600 mg or 1200 mg achieved endoscopic response,
respectively, versus 11 percent in the placebo group (p<0.001).2 Additionally, multiplicity-adjusted key secondary endpoints showed significant clinical and endoscopic outcomes,
with symptom improvement observed as early as week 4.1,2 After 4 weeks of treatment in both studies, a greater proportion of patients receiving either dose of risankizumab achieved
clinical response (per CDAI) compared to placebo.1,2 Specifically, in ADVANCE, 41 and 37 percent of patients receiving risankizumab 600 mg or 1200 mg achieved clinical response
(per CDAI) compared to 25 percent in the placebo group (p<0.001 for 600 mg; p=0.008 for 1200 mg).1 In MOTIVATE, 36 and 33 percent of patients receiving risankizumab 600 mg
or 1200 mg achieved clinical response (per CDAI), respectively, compared to 21 percent in the placebo group (p=0.002 for 600 mg; p=0.012 for 1200 mg).
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IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include
Long-Term Data for Waldenström's Macroglobulinemia (WM)
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Solution Description
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA® (ibrutinib) Prescribing Information to include efficacy
and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström's macroglobulinemia (WM), based on the final analysis of the
Phase 3 iNNOVATE study. First approved in 2013, IMBRUVICA is currently available to patients with several types of blood cancer, as well as chronic graft-versus-host
disease. It was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018 based on the iNNOVATE primary analysis. As of today,
IMBRUVICA is the only Bruton's tyrosine kinase (BTK) inhibitor approved to treat WM. WM typically affects older adults and is primarily found in the bone marrow,
although lymph nodes and the spleen may also be affected. In the U.S., there are approximately 2,800 new cases of WM each year.1 The National Comprehensive Cancer
Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends IMBRUVICA, with or without
rituximab, as the only Category 1 Preferred regimen for patients with previously untreated or previously treated WM.2, The IMBRUVICA Prescribing Information now
includes final analysis data, with an overall follow-up of 63 months, from the Phase 3 iNNOVATE clinical trial. With additional follow-up since the primary analysis, the
combination of IMBRUVICA plus rituximab continued to demonstrate prolonged progression-free survival (PFS) in WM patients compared to rituximab monotherapy.
Patients treated in the IMBRUVICA arm experienced a 75 percent reduction in risk of disease progression or death compared to rituximab monotherapy (hazard ratio
[HR] 0.25; 95% confidence interval [CI]: 0.15-0.42; p<0.0001). Results from the final analysis of the study were recently featured as an oral presentation at the 2020
American Society of Hematology (ASH) Annual Meeting (Abstract #336).
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European Medicines Agency Validates Bristol Myers (USA) Squibb’s Application for Opdivo (nivolumab) Combined with Chemotherapy as
First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma
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Solution Description
Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated its Type II Variation Marketing Authorization Application
(MAA) for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of
adult patients with advanced or metastatic gastric cancer (GC), gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma (EAC).
Validation of the application confirms that the submission is complete and initiates the EMA’s centralized review process. The filing is based on results
from the pivotal Phase 3 CheckMate -649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or
capecitabine and oxaliplatin (CapeOX) was compared to treatment with chemotherapy alone. Results showed a statistically significant and clinically
meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic GC, GEJ
cancer or EAC whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5 (the primary endpoints of the study). The statistically significant
OS benefit shown with Opdivo plus chemotherapy was also observed in PD-L1 positive patients with CPS ≥ 1 and in the all-randomized population.
The safety profile observed for Opdivo plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual
treatments. Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -649 trial.
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Amgen (USA) Licenses AMG 634, An Investigational Treatment For Tuberculosis
And Leprosy, To Medicines Development for Global Health
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Solution Description
Amgen and Medicines Development for Global Health (MDGH), a non-profit biopharmaceutical company, announced that the companies
have entered into a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated for the treatment of
tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy. The compound
is in Phase 2 development with studies led by the Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study). Amgen had
acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene in 2019. Under the terms of the
agreement, MDGH will assume full responsibility for the further development and commercialization of AMG 634. Amgen will continue to
support the two Phase 2 clinical trials in ENL and TB set to begin in 2021 by providing study drug to both studies and funding the ENL study.
This support will help ensure a seamless transition in development to MDGH. According to the World Health Organization (WHO), in 2019,
an estimated 10 million people were infected with TB, including over 1 million children, and 1.4 million people died of TB.1 Leprosy, also
known as Hansen's disease, affects the skin, peripheral nerves mucosal surfaces of the upper respiratory tract and the eyes. 2 ENL is an
autoimmune complication that can occur many years after being cured of leprosy, and can cause permanent nerve damage and disability.
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Illumina (USA) New Bioinformatics Solution Powers Multi-Omics Discovery at
Massive Scale
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Solution Description
Illumina, Inc. is transforming genomic data bottlenecks into catalysts with the launch of Illumina Connected Analytics (ICA). This new and
integrated bioinformatics solution provides a comprehensive, private, cloud-based data platform that empowers customers to manage,
analyze, and explore large volumes of multi-omic data in a secure, scalable, and flexible environment. Accessible through a web portal or
through a rich set of APIs, ICA reduces the extra work and possible human-error associated with combining multiple datasets, through a direct
sequencer-to-platform transfer of data onto the private Illumina cloud. With security and compliance at the core, the data is able to be seen,
read, automatically processed, analyzed and shared securely. Optimized for high-throughput, ICA also supports the complex storage,
aggregation, and querying of multi-omic sequencing and array data from around the world. Harnessing the technology brought from the 2020
acquisition of BlueBee, ICA is advancing Illumina’s cloud portfolio by giving users the flexibility to run custom analyses and access industry
leading options, including award-winning Illumina informatics solutions, such as the DRAGENTM Bio-IT Platform. Designed for the
unprecedented scale in the next decade of sequencing, ICA uniquely provides customers the ability to manage the vast amount of genomic
data being generated on our installed base of more than 17,000 sequencing systems and into the future.
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Johnson & Johnson (USA) DARZALEX FASPRO® Becomes the First FDA-Approved
Treatment for Patients with Newly Diagnosed Light Chain Amyloidosis
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Solution Description
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with
newly diagnosed light chain (AL) amyloidosis. DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with
the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver. This indication is approved under accelerated approval
and is based on the hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical
benefit in a confirmatory trial. DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class
IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. The FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which
were recently presented at the American Society of Hematology (ASH) 2020 Annual Meeting. The study evaluated DARZALEX FASPRO® in combination with VCd, compared with
VCd alone, a common treatment regimen used in adult patients with newly diagnosed AL amyloidosis. Patients receiving treatment with DARZALEX FASPRO® experienced a
hemCR more than triple that of patients receiving VCd alone.1 Approximately 4,500 people in the U.S. develop this rare disease each year. AL amyloidosis is a life-threatening blood
cell disorder that occurs when blood plasma cells in the bone marrow produce amyloid deposits, which build up in vital organs and eventually cause organ deterioration.3 The disease
can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, gastrointestinal tract and nervous system.2,3 About one-third
of patients visit five or more doctors before receiving a diagnosis, and 72 percent are diagnosed more than one year after they first experience symptoms.3,4 Patients often have a poor
prognosis due to the delay in diagnosis of AL amyloidosis, which frequently presents with non-specific symptoms that can mimic other, more common conditions. As many as 30
percent of patients with AL amyloidosis die within the first year after diagnosis.
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Merck Announces Supply Agreement with U.S. Government for Initial Doses of Investigational
Biological Therapy for the Treatment of Patients with Severe and Critical COVID-19
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Solution Description
Merck, known as MSD outside the United States and Canada, announced it has entered into an agreement with the United States Government to
support the development, manufacture and initial distribution of an investigational biological therapeutic upon approval or Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration. Merck acquired MK-7110 through the acquisition of OncoImmune, a privately
held, clinical-stage biopharmaceutical company. Under the agreement, Merck will receive up to approximately $356 million for manufacturing and
supply of approximately 60,000-100,000 doses of MK-7110 to the U.S. Government through June 30, 2021 to meet the government’s Operation
Warp Speed goals. This approach is intended to expedite delivery of MK-7110 to the American people as quickly as possible, following potential
EUA or FDA approval. Merck is also investing to expand its manufacturing capacity to increase supply of MK-7110. In September 2020,
OncoImmune reported topline findings from an interim efficacy analysis of a Phase 3 study evaluating MK-7110 for the treatment of patients with
severe and critical COVID-19. An interim analysis of data from 203 participants (75% of the planned enrollment) indicated that hospitalized
patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared to
placebo, as defined by the protocol. The risk of death or respiratory failure was reduced by more than 50%.
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Roche (Switzerland) confirms US government agreement to purchase
additional doses of Regeneron’s casirivimab and imdevimab
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Solution Description
Roche confirmed that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of Regeneron’s
casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed. The US government said it will provide
these additional doses at no cost to patients, though healthcare facilities may charge fees related to administration, and will continue to coordinate allocation of the
antibody cocktail to state and territorial health departments. Under the new agreement, the US government will purchase up to 1.25 million finished doses of casirivimab
and imdevimab by 30 June 2021. Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to over 1.5 million
doses in the US. The efficacy and safety of casirivimab and imdevimab continue to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalised
and non-hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK, and a trial for the prevention of COVID-19 in household
contacts of infected individuals. Lower doses of casirivimab and imdevimab are also being studied with the aim of increasing supply and offering the therapy to more
patients. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Roche is collaborating with Regeneron to increase global supply
of casirivimab and imdevimab, with the aim of having more than 2 million treatment doses available annually. Regeneron is responsible for the development and
distribution of the treatment in the US, and Roche is primarily responsible for the development and distribution outside the US. Roche is actively working with
governments outside of the US on potential supply agreements. The companies share a commitment to making the antibody cocktail available to COVID-19 patients
around the globe if approved and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health
organisations.
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Roche (Switzerland) launches two digital pathology image analysis
algorithms for precision patient diagnosis in breast cancer
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Solution Description
Roche announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image
analysis for breast cancer to help determine the best treatment strategy for each patient. The image analysis algorithms use artificial intelligence to
support pathologists in making faster, more accurate patient diagnoses in breast cancer. A mutation in the HER2 gene, which occurs in as many as 20
percent of the 2.1 million cases of breast cancer diagnosed globally each year, is responsible for aggressive growth in some patients. Identifying this
mutation is important in determining which patients may benefit from targeted treatment. uPath HER2 (4B5) image analysis for breast cancer helps
pathologists to quickly determine whether tumors are positive for the HER2 biomarker, highlighting positively stained tumor cell membranes with a
clear visual overlay for easy reference. uPath HER2 Dual ISH image analysis for breast cancer assists the pathologist in the determination of HER2
gene amplification. A heatmap is provided to guide pathologists to areas of interest where the algorithm can identify cells to inform the determination
of a treatment strategy. Validated on the VENTANA HER2 (4B5) assay and the VENTANA HER2 Dual ISH DNA Probe Cocktail, the algorithms are
ready-to-use and integrated within the Roche uPath enterprise software. The uPath HER2 (4B5) image analysis and uPath HER2 Dual ISH image
analysis algorithms for breast cancer expand Roche’s digital pathology portfolio to empower precision diagnosis. Roche is continuing to innovate in
HER2 diagnostics through image analysis algorithms that provide an actionable assessment of scanned slide images that are objective and reproducible.
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Thermo Fisher Scientific (USA) Offers Financial Flexibility with New
Managed Equipment Solutions
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31
Solution Description
Thermo Fisher Scientific Inc. the world leader in serving science, announced the launch of Managed Equipment Solutions, a
new subscription-based offering that bundles instrument and equipment procurement with consumables, applications support,
software, training and extended service in a convenient and cost-efficient agreement. Managed Equipment Solutions (MES)
is ideal for biopharma companies, academic institutions, healthcare organizations and industrial businesses seeking
innovative procurement models that offer all the benefits of premium instrument procurement but with increased flexibility.
MES gives customers in research, life sciences, specialty diagnostics and applied markets the assurance of long-term,
consistent analytical technology performance with predictable subscription costs and a pathway to future innovation. As an
integrated solution, MES can reduce total cost of ownership while preserving capital budgets. Meanwhile, it protects against
technology obsolescence by enabling customers to upgrade their instruments and equipment every three to five years. MES
is provided through a single, easy to manage agreement, resulting in a highly streamlined procurement process.
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United Healthcare (USA) Expands Access to Virtual Care, Including a New
Virtual Primary Care Offering
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Solution Description
United Healthcare has expanded the availability of virtual care with local physicians for members enrolled in employer-sponsored plans, and also introduced a new Virtual
Primary Care service designed to enable access to medical services in a simpler and more convenient way. Through both efforts, eligible members may be able to visit virtually
with health care providers for various types of care, including wellness, routine and chronic condition management. To help improve access to local care providers,
UnitedHealthcare has updated a policy to help encourage the use of virtual care and enable eligible members to meet with their physicians virtually. Effective Jan. 1, the policy
applies to fully insured and self-insured employer plans and will continue to reimburse local primary care physicians, specialists and select therapy providers for administering
certain care through telehealth as an alternative to in-person visits. The new Virtual Primary Care service, which is designed to make it easier for people to establish and maintain
a relationship with a primary care physician, is currently available for members enrolled in certain employer-sponsored fully insured or self-funded health plans in 11 states.
The service, offered in collaboration with a national telehealth provider group, is expected to be expanded to more states in 2021 and is part of a broader UnitedHealthcare effort
to help enable members to use technology to access care. The number of Americans with a primary care physician has declined recently, with an estimated 25% of people
lacking this type of ongoing relationship with a care provider.1 Reversing that trend can be important given people with a relationship with a primary care physician may be
more likely to receive high-value care services, such as preventive screenings, and report better care access and experiences compared to people without this type of care
provider.2 According to a recent UnitedHealthcare survey, one-quarter of respondents said they would actually prefer a virtual relationship with a primary care physician rather
than in-person visits. Separately, some people who see a doctor virtually report no difference in the quality of the visit, compared to an in-person appointment; meanwhile
another study found patients “vastly preferred” a virtual experience, due to the convenience and the elimination of travel time.
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Optum Insight and Change Healthcare Combine to Advance a More Modern,
Information and Technology-Enabled Health Care (USA) Platform
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Solution Description
Optum, a diversified health services company and part of UnitedHealth Group and Change Healthcare a health care technology leader, have agreed to combine. Change
Healthcare will join with OptumInsight to provide software and data analytics, technology-enabled services and research, advisory and revenue cycle management
offerings to help make health care work better for everyone. This combination unites two technology and service companies focused on serving health care. Their
combined capabilities will more effectively connect and simplify core clinical, administrative and payment processes - resulting in better health outcomes and
experiences for everyone, at lower cost. Change Healthcare brings key technologies, connections and advanced clinical decision, administrative and financial support
capabilities, enabling better workflow and transactional connectivity across the health care system. Optum brings modern analytics, comprehensive clinical expertise,
innovative technologies and extensive experience in improving operational and clinical performance. The agreement calls for the acquisition of Change Healthcare’s
common stock for $25.75 per share in cash and is expected to close in the second half of 2021, subject to Change Healthcare shareholders’approval, regulatory approvals
and other customary closing conditions. Private equity funds affiliated with The Blackstone Group, which own approximately 20% of the common stock of Change
Healthcare, have agreed to vote the shares they control in favor of the combination. The acquisition is expected to be accretive to UnitedHealth Group’s net and adjusted
earnings per share by approximately $0.20 and $0.50 respectively in 2022, advancing strongly in subsequent years, inclusive of investments to accelerate technology,
system and product integration and development activities to more quickly deliver the value of this combination to all health care system stakeholders. Adjusted earnings
exclude from net earnings only the after-tax non-cash amortization expense pertaining to acquisition-related intangible assets.
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Roche (Switzerland) to present updated data confirming Tecentriq in combination with Avastin
substantially improves overall survival in people with the most common form of liver cancer
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Solution Description
Roche will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq® in combination with Avastin®
(bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. After
a median follow-up of 15.6 months, an updated analysis showed that Tecentriq in combination with Avastin reduced the risk of death (OS) by 34%, with a
median OS of 19.2 months, compared with 13.4 months for sorafenib (hazard ratio [HR]=0.66; 95% CI: 0.52–0.85). The updated OS, along with progression
free survival (PFS) and objective response rate (ORR) results, were consistent with the primary analysis and support the use of the combination in HCC.
Safety data for Tecentriq and Avastin were consistent with the known safety profiles of each individual drug, with no new safety signals identified. These
data will be presented in the Rapid Abstract Session: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer at the
Gastrointestinal Cancers Symposium on Sunday 17 January at 15:30-16:15 ET. Tecentriq in combination with Avastin is now approved around the world,
including in the US, China, Japan and the EU, for people with unresectable HCC and is recommended in many clinical practice guidelines globally. Roche
is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day
stopping chronic liver disease. 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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42. Customer Success Updates
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Henry Schein (USA): The Joint Venture Will Offer an Expanded Array of
Products and Services to Customers in Spain and Portugal
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Henry Schein, Inc. the world’s largest provider of health care solutions to office-based dental and medical practitioners, and Casa Schmidt, S.A., a comprehensive provider of
dental solutions for dental professionals in Spain and Portugal, announced the completion of a joint venture to advance their mutual goal of helping health care professionals
operate more efficient practices by providing new solutions and technologies for the ultimate benefit of patients. The transaction was announced on March 10, 2020, and
approved on June 30, 2020, by Spain’s National Commission of Markets and Competition. The joint venture will operate in Spain and Portugal under the Henry Schein name.
The company will include Henry Schein’s comprehensive portfolio of business, clinical, technology, and supply chain solutions. It will also include all of Casa Schmidt’s lines
of business including Schmidt Dental Solutions, a full service distributor of dental products and services to dental offices, laboratories, universities, and hospitals in Spain and
Portugal; Servimed, which provides technical support to dental practitioners and dental specialists including surgeons and orthodontists; and Importación Dental
Especialidades, a supplier of specialized implantology and orthodontics products and services. In addition, the joint venture will be complemented by Henry Schein One’s
market leading practice management and patient communication software, as well as the comprehensive implant systems, digital workflows, and innovative regenerative
solutions offered by CAMLOG and BioHorizons, the foremost brands of Henry Schein’s Global Dental Surgical Group. Henry Schein will have majority ownership of the joint
venture, with senior management from Henry Schein and Casa Schmidt serving on the management team. Henry Schein’s Juan M. Molina will serve as the Managing Director
of the joint venture. Casa Schmidt was founded in 1919 by Georg Schmidt and began operating as Schmidt Dental Solutions in 2019. The company has grown into a full-service
dental distributor that offers more than 55,000 consumable merchandise and dental products, including multiple product exclusives, and had more than €35 million in sales in
2019. Headquartered in Madrid, Casa Schmidt has nearly 240 employees and 19 locations.
Description
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Astellas (Japan) Announces a Research Collaboration with Actinium for
Molecular Targeted Radiotherapy
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Astellas Pharma Inc. has entered into a research collaboration for molecular targeted radiotherapies with Actinium Pharmaceuticals, Inc. Chief Executive
Officer and Chairman of the Board. This collaboration is a component of Astellas’ initiative to develop “theranostics” as part of its Rx+® business1.
Theranostics is a combined term of “therapeutics” and “diagnostics”, defined as a treatment protocol or concept in which healthcare professionals assess
lesion sites and simultaneously determine the appropriate treatment for each patient2. Through utilization of a diagnostic agent developed in parallel with a
therapeutic agent that shares the same target, it may be possible to identify patients in advance who would benefit from the treatment. This approach may
help healthcare professionals provide more efficient and effective treatment. In this collaboration, the potential therapeutic effect will be assessed by
combining certain targeted oncology drugs that were discovered by Astellas based on its drug discovery capabilities cultivated thus far with Actinium’s
nuclear medicine technology which utilizes an alpha particle-emitting radioisotope3. Astellas is already conducting pre-clinical trials of the diagnostic agents
on the target molecule.
When a promising therapeutic drug candidate is identified in the course of this collaboration, clinical trials for the theranostics may
be initiated. Through its Rx+® business, Astellas aims to realize a society where people can live in their own way, both physically and mentally through
scientifically based on scientific evidence. Astellas aims to optimize therapeutic approach by improving diagnostic and surgical accuracy and maximize
patient outcomes. The development of theranostics that integrates diagnostics and therapeutics is part of this effort.
Description
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CVS Health collaborates with Cancer Treatment Centers of America to
provide in-home chemotherapy
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CVS Health announced it is working with Cancer Treatment Centers of America® to increase access to chemotherapy at home for eligible, fully insured patients. Together, the
companies are focused on minimizing patient exposure to COVID-19 from inpatient or hospital outpatient settings during the ongoing pandemic while ensuring continuity of
critical cancer care. The program leverages Coram’s home infusion capabilities, coupled with training in chemotherapy administration based on Oncology Nursing Society
guidelines, harnessing CTCA’s expertise as a top oncology care provider to give patients who may have delayed their care due to COVID-19 the flexibility to receive treatment
from the safety and comfort of home. Clinically eligible and fully insured CTCApatients with a range of cancers, including breast cancer, lung cancer, prostate cancer, colorectal
cancer, head and neck cancers, and some genitourinary cancers on particular chemotherapy/immunotherapy medications, will begin their first cycles of infused chemotherapy
in the hospital or outpatient care center, and, if tolerated over a number of months, can be transitioned home for continued infusions. Once home, patients will receive in-home
Coram nurse visits to administer the therapy, paired with regular telehealth visits and digital therapeutic check-ins with their CTCA clinician, care team, pharmacists and other
clinical staff as needed. More information is available at www.cancercenter.com/oncology-clinic-at-home. In collaboration with CTCA and their approach to quality, safe care,
coupled with more than 35 years of infusion expertise, Coram has the ability to reach 97 percent of the U.S. population. The program is being piloted in the Atlanta market and
will expand to other geographies over the next few months to help increase access to important home-based cancer care during and beyond the pandemic. More information on
the steps that CVS Health is taking to address the COVID-19 pandemic is available at the company's frequently updated COVID-19 resource center.
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Gilead (USA) and Vir Biotechnology Establish Clinical Collaboration to Explore
Combination Strategies for Functional Cure for Chronic Hepatitis B Virus
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Gilead Sciences, Inc. and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic
combination strategies aimed at developing a functional cure for chronic hepatitis B virus .The companies plan to initiate a Phase 2 trial evaluating
combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different
combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA);
and a commercially-sourced, marketed PD-1 antagonist. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy®
(tenofovir alafenamide fumarate, TAF). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an
off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum. Both companies retain full rights to their individual product
candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial. HBV affects more
than 290 million people worldwide. Globally, HBV is a leading cause of liver cancer and each year it is estimated that more than 800,000 people die of
HBV-related liver disease. While current antiviral therapies result in sustained HBV viral suppression, they rarely completely clear the virus and
therefore people with HBV require lifelong therapy. The safety and efficacy of selgantolimod and VIR-2218 have not been established. They are
investigational compounds, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
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Rigshospitalet and Lundbeck (Denmark) announce partnership to find new ways to
treat brain diseases
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H Lundbeck enters a partnership with the Department of Neurosurgery at Rigshospitalet, which will provide new insights into
how molecules enter the brain. The partnership gives researchers an opportunity to study fluids surrounding the brain to learn
which compounds enter the brain and how they are distributed. The project is basic research, with a view to making the results
widely available.One of the major challenges in brain research is the so-called blood-brain-barrier, which is a brain defense
system between the blood system and the brain. The barrier blocks harmful molecules in the bloodstream from entering the brain.
Under normal circumstances, this is a natural mechanism to protect the brain, but can be an obstacle when medicines need to enter
the brain to treat diseases such as Alzheimer’s disease, Parkinson’s disorder, or schizophrenia. There is a need for validated
methods that prove how much of a drug gets through the blood-brain-barrier and into the brain, and where it can have a beneficial
treatment effect. It is this challenge that the collaboration will try to solve. The study is voluntary for patients. There are no
changes or differences in the surgical procedures between the patients who choose to participate and those who do not.
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Illumina (USA) Announces New and Expanded Oncology Partnerships with Bristol Myers Squibb,
Kura Oncology, Myriad Genetics, and Merck to Advance Comprehensive Genomic Profiling
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Illumina is pleased to announce a portfolio of new and expanded oncology partnerships that further the company’s commitment to develop standardized, globally
distributable tools for precision oncology. announced a series of oncology partnerships that aim to expand the reach of its powerhouse comprehensive genomic profiling
family of products, TruSight™ Oncology. TruSight Oncology 500 (TSO 500) is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known
and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants critical for cancer development and
progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the
TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500 and is currently undergoing review
with regulatory authorities. It is expected to be launched in both the U.S. and Europe later this year.
Illumina is leveraging the content of its TSO 500 assay to develop companion diagnostics. The following partnerships demonstrate Illumina’s commitment to
collaborating with industry leaders on cancer diagnostics and the advancement of precision oncology:
• BRISTOL MYERS SQUIBB: Expanding on a collaboration that began in 2018, Bristol Myers Squibb will develop a microsatellite instability CDx, as well as develop
a diagnostic based on the content of TruSight Oncology 500 ctDNA, Illumina’s first liquid biopsy assay. Both program expansions are planned for global use by Bristol
Myers Squibb’s portfolio of cancer therapeutics.
• KURA ONCOLOGY: Our partnership with Kura Oncology is focused on building a CDx claim for HRAS mutations in Head and Neck Squamous Cell Carcinomas.
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49. Partner Ecosystem Updates
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Smith+Nephew (UK) partners with Movemedical to streamline inventory
management and improve customer experience
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41
Smith+Nephew , the global medical technology business, announces the successful introduction of its new field sales
operations and inventory automation solution in the US in partnership with Movemedical. The new platform is designed
to deliver a more simplified and efficient way for field sales reps to manage their daily inventory operations - ultimately
helping them better serve their surgeon customers. Before the Movemedical solution was introduced, inventory
management processes lacked the automation and transparency needed to align with healthcare facility requirements. This
new solution will now enable better patient-matched logistics, helping Smith+Nephew deliver industry leading customer
service. The sales force and operations teams will benefit from real-time data enabling smooth matching of customer
requirements and product availability. The Movemedical solution will help ensure that the right product gets to the right
customer – and the right patient – through the provision of clean and accurate data in real-time, empowering our teams to
make faster and better decisions
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50. Partner Ecosystem Updates
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Skyhawk and Vertex (USA) Establish a Strategic Collaboration to Discover and Develop
Novel Small Molecules that Modulate RNA Splicing for Serious Diseases
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42
Skyhawk Therapeutics, Inc. and Vertex Pharmaceuticals Incorporated announced a strategic research collaboration and
licensing agreement aimed at the discovery and development of novel small molecules that modulate RNA splicing for the
treatment of serious diseases. Under the collaboration agreement, Vertex will pay Skyhawk $40 million upfront. Skyhawk
will grant Vertex options to exclusively license worldwide intellectual property rights to candidates discovered and
developed under the collaboration that are directed to program targets. Following Vertex’s exercise of its options, Vertex
will be responsible for further development and commercialization. Skyhawk is also eligible to receive up to $2.2 billion
in potential milestone payments, as well as potential royalties on future sales.
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Gilead Sciences (USA): Kite and Oxford Bio Therapeutics Establish Cell Therapy
Research Collaboration in Blood Cancers and Solid Tumors
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43
Kite, a Gilead Company, and Oxford Bio Therapeutics Ltd. a clinical stage oncology company with a pipeline of
immuno-oncology (IO) and antibody-drug conjugate (ADC)-based therapies, announced that the companies have
entered into a research collaboration to evaluate five novel targets for a number of hematologic and solid tumor
indications. Through this collaboration, OBT will validate five novel oncology drug targets, previously identified using
OBT’s OGAP® discovery platform, and generate antibodies against these targets. Kite and Gilead will have the
exclusive right to develop and commercialize therapies based on these targets or antibodies. Under the terms of the
agreement, OBT will receive an upfront payment and will be eligible to receive additional payments based on
achievement of certain discovery, clinical and regulatory milestones, as well as royalties on future potential sales.
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Illumina (USA) and Helix Collaborate to Assess Prevalence of New SARS-CoV-2
UK Variant (B.1.1.7) in the US and Develop National Surveillance Infrastructure
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44
Illumina, Inc. and Helix announced a collaboration to augment national surveillance infrastructure in the US to track the emergence and
prevalence of novel strains of SARS-CoV-2 with support from the CDC. The combination of Illumina’s sequencing technology and
expertise and Helix’s national COVID-19 testing footprint will significantly expand the country’s existing surveillance efforts to detect
and characterize emerging variants of SARS-CoV-2. The collaboration has already demonstrated results – identifying 51 of the first 54
cases of B.1.1.7, the highly transmissible variant first found in the UK, reported in the US. Over the past several weeks, Helix has
analyzed recent positive samples and identified those with ‘S gene dropout’ on their diagnostic PCR assay, indicating the potential
presence of the emerging B1.1.7 variant in different regions in the US. Illumina then sequenced a subset of these ‘S gene dropout’samples
using Illumina’s COVIDSeq Test, which identified the B.1.1.7 variant in 4 samples from California and Florida. Helix and Illumina are
expanding the scope of their collaboration to examine a higher volume of samples on an ongoing basis for both the presence of B.1.1.7
and new strains. This will empower public and private entities to react quickly to any potential changes in pathogenicity of the virus or
effectiveness of diagnostics, therapeutics, and vaccines.
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Environment & Social Updates
Healtcare Industry
54. Environment & Social
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Amgen (USA) To Achieve Carbon Neutrality By 2027
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45
Amgen announced the launch of a new seven-year environmental sustainability plan, which includes a commitment to achieve carbon
neutrality, while also reducing water use by 40% and waste disposed by 75%. Since 2007, Amgen has implemented projects resulting in a 33%
reduction in carbon emissions, a 30% reduction in water use and a 28% reduction in waste. These reductions were achieved even as the
company increased production capacity, expanded our presence to more than 100 countries and grew revenues significantly. Amgen will
invest more than $200 million to achieve these 2027 environmental commitments, and expects that such investment will help us to become
not just more environmentally sustainable but also more flexible and productive, resulting in reductions in operating costs from such
efficiencies over the same period. The company will focus on the use of innovative technologies to significantly reduce carbon emissions from
Amgen-owned operations, as well as on sourcing renewable energy. For example, Amgen's newest biomanufacturing plant in Singapore
generates 70% less carbon than traditional biomanufacturing facilities. The company has built a second such plant in Rhode Island. Where
carbon emissions cannot be eliminated from its operations, Amgen will invest in sustainability projects that sequester or avoid greenhouse gas
emissions. In addition, Amgen will engage with its suppliers to assist and encourage carbon reductions throughout its value chain.
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55. Environment & Social
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Sesame Workshop - India and Viatris Inc. Launch Animated Videos & Other Resources
to Help Indian Families Address Socio-Emotional Needs Through the Pandemic
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46
As the COVID-19 pandemic continues to affect children and families across India, Sesame Workshop - India and Viatris Inc. are launching new resources to
support the social and emotional needs of children, parents, and other caregivers in families.they release of materials on SesameWorkshopIndia.org/covid-19-care
in English and other languages is designed to help young children talk through and name big feelings like stress and fear, encourage positive caregiving strategies
and routines, and help families find ways to celebrate together when far apart. Made possible by the generous support of Viatris, the new global resources will reach
families on 6 continents. Starting this week, new animations and activities will launch on a rolling basis in India that will help caregivers with simple language and
tact to talk to their children about the sudden change in their routines and how they can cope with their new reality while managing stress and anxiety. In one video,
Grover and his mom decide to make his Grandmother’s special family soup over video chat when they can’t be together for their holiday celebration. In additional
videos, Elmo and his mom talk about big feelings and Elmo’s dad helps him name and cope with the feeling of fear of getting sick. Additional topics released on
a rolling basis will include keeping routines, spending special time together, and learning about persistence. Viatris, a new kind of global healthcare company, is
committed to doing its part in support of public health needs amid the COVID-19 pandemic. In addition to the generous support to make these new resources
possible, Viatris will share the resources with its workforce in India. The resources launched as part of Sesame Workshop’s Caring for Each Other initiative, which
was created in response to the uncertainty facing families during the COVID-19 pandemic, has reached families in more than 100 countries and 41 languages.
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56. Environment & Social
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Teva (Israel) Sets Ambitious Long-Term Environmental Goals As Part of Renewed ESG
Strategy
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47
Teva Pharmaceutical Industries Ltd. has announced long-term environmental sustainability commitments and targets to provide direction and drive action in this area. Our new goals are part of Teva’s commitment to Environmental,
Social and Governance (ESG) measurement, a key focus area for the business. ESG details how we achieve our business goals, underscores non-financial performance, and is considered critical to our long-term sustainability and
success.
These environmental sustainability commitments are aligned to three areas of focus that were identified during the company’s recently completed ESG materiality analysis, which informed the development of our renewed strategy:
• Climate Action and Resilience
• Responsible Use of Natural Resources
• Emissions, Effluents and Waste
Specifically, the company has committed by 2030 to:
• Reduce absolute Scope 1 and 2 greenhouse gas (GHG) emissions by 33% versus 2017 levels to support efforts to limit the global temperature increase to well below 2°C, aligning with the 2015 Paris Climate Agreement.
• Improve transparency of Scope 3 GHG emissions and increase engagement on climate issues with key suppliers throughout the value chain.
• Increase energy efficiency by 10% and the total proportion of energy purchased or generated from renewable sources to 50%.
• Reduce total water withdrawal by 10% in areas projected to be in water stress.
• Assess and mitigate the environmental impact of pharmaceutical ingredients used in operations.
• Reduce the overall mass of secondary and tertiary packaging materials per unit dose and increase the proportion of recycled and responsibly-sourced materials by 10%.
• Assess the environmental lifecycle impact of key products.
• Continue to minimize waste generated from operations and the environmental impact of its disposal.
• Meet existing AMR Industry Alliance commitments to minimize antimicrobial discharges from the supply chain.
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Miscellaneous
Updates Healthcare Industry