News & Analysis as of

Research and Development Pharmaceutical Industry Coronavirus/COVID-19

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

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The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Mintz

Seizing Opportunity: The post-pandemic future of US life sciences M&A 2022

Mintz on

As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more

AEON Law

Patent Poetry: Dispute over COVID Vaccine Shows Importance of Inventorship

AEON Law on

Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more

Maynard Nexsen

The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?

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Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the...more

Goodwin

Navigating The New Normal: Disruption And Reinvention: The Pivot to Local Supply Chains

Goodwin on

It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

McDonnell Boehnen Hulbert & Berghoff LLP

Science Does Not Support the Latest COVID Hysteria

In a time of a global pandemic, with antivaxxer and anti-science sentiments running rife, and when combinations of fear, distrust, and paranoia are rampant, it is easy for important results from basic science to become fodder...more

Womble Bond Dickinson

Computer Science Meets Medicine in Drug Discovery

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AI has the potential to revolutionize healthcare worldwide. In drug discovery, AI has already shown success. Sumitomo Dainippon Pharma and the UK-based AI company Exscientia developed DSP-1181 to treat obsessive compulsive...more

Hogan Lovells

FDA issues new policy for evaluating impact of viral mutations on COVID-19 tests

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The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - February 2021: Market News

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Other recent notable industry transactions: Thermo Fisher Scientific Inc. completed the acquisition of Henogen SA, Novasep's viral vector manufacturing business in Belgium for approximately €725 million in cash....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 9

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In Washington: House managers finished presenting their case against former President Trump at his impeachment trial on Thursday. They argued that Trump's statements prior to and at the January 6 "Stop the Steal" rally...more

Morgan Lewis

FDA Issues More Guidance on Gene and Cell Therapy Products

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January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more

McDonnell Boehnen Hulbert & Berghoff LLP

Do mRNA-based COVID Vaccines Have an Achilles Heel?

The COVID-19 pandemic has spread throughout the globe, infecting more than 90 million people and causing almost two million deaths (see "Tracking coronavirus' global spread"). SARS-CoV-2 infection is the cause of the...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - December 2020: Antimicrobial Resistance (AMR) – A Personal Perspective

Dechert LLP on

“Our world faces a silent, slow-moving global threat that kills around 700,000 people each year due to the uncontrolled rise of superbugs resistant to antibiotics. These superbugs can affect anyone, of any age, in any...more

International Lawyers Network

Canadian Innovation During The COVID-19 Pandemic

Canadian Innovation Week, namely November 16th to November 20th this year, is a movement organized by the Rideau Hall Foundation and Canadian Innovation Space which seeks to recognize Canadians advancing their respective...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Hogan Lovells

[Virtual Event] AI – A brave new world? - December 1st, 11:00 am - 12:15 pm EST

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Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Haug Partners LLP

Vaccine Design Will Likely Determine the Success of Each COVID-19 Vaccine

Haug Partners LLP on

This article provides a basic overview of the immune system and how its successful engagement is necessary to produce a commercial vaccine, with a specific focus on the SARS-CoV-2 virus that causes the COVID-19 disease and...more

Faegre Drinker Biddle & Reath LLP

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

Why Do Clinical Trials? Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more

Seyfarth Shaw LLP

FDA Approves Veklury (remdesivir) As The First Treatment For COVID-19

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On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....more

Goodwin

The Impact of Technology in the Growth of the Life Sciences Industry

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Perhaps nowhere do technology and real estate intersect more deeply than in the life sciences industry, where sophisticated technologies are integral to tenants’ operations. The life sciences industry, which was experiencing...more

Goodwin

Global Trends and Opportunities in Life Sciences Real Estate – Spotlighting the U.S. and the UK

Goodwin on

An aging global population, a once-in-a-century pandemic and the continued convergence of scientific breakthroughs like cell and gene therapies and artificial intelligence are among just a few of the key factors that continue...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

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This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

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