News & Analysis as of

Coronavirus/COVID-19 Vaccinations Pharmaceutical Industry

Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
ArentFox Schiff

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

ArentFox Schiff on

On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more

Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

Goodwin on

On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®.  The updated vaccine targets the LP.8.1 variant of...more

Goodwin

Final Judgment of Non-Infringement Entered in Alnylam v. Pfizer Vaccine Patent Dispute

Goodwin on

​​​​​​​On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...more

Sands Anderson PC

Vaccination Injury is a Matter of Time

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If you believe you were injured by any of the 16 vaccines covered under the National Vaccine Injury Compensation Program you must have symptoms of the claimed injury lasting at least six months to be able to file a claim for...more

Goodwin

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more

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

McCarter & English, LLP

New Informed Consent Guidance and Pharmacy Immunity

New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more

Troutman Pepper Locke

Navigating the Future of Pharmacy Law: Key Takeaways From the 2023 American Society of Pharmacy Law Conference

Troutman Pepper Locke on

Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more

Foley Hoag LLP

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

Foley Hoag LLP on

Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023

This Week in Washington: Workforce issues studied, PBMs under more scrutiny...more

Alston & Bird

Health Care Week in Review: State of the Union and HHS Guidance on Drug Rebates and PHE

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDonnell Boehnen Hulbert & Berghoff LLP

"Zero Draft" of WHO CA+ Released

On February 1, the World Health Organization (WHO) released a "zero draft" of a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (or "WHO CA+") for the...more

Akin Gump Strauss Hauer & Feld LLP

USITC Sets Out Process of Its Investigation into TRIPS Waiver Expansion

On February 1, the USITC formally announced the opening of its investigation into the merits of expanding the TRIPS Waiver to diagnostics and treatments. The investigation was initially requested by USTR, who had been leading...more

White & Case LLP

PMB performs as pharma groups repurpose their portfolios

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After a year of historic profits in 2021 following the mass roll-out of COVID-19 vaccines and related treatments, big pharma companies armed with cash for deals have been shifting their attention - Overall, pharma, medical...more

Knobbe Martens

BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda

Knobbe Martens on

Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the...more

McDonnell Boehnen Hulbert & Berghoff LLP

WTO TRIPS Council Recommends That General Council Extend Waiver Deadline

On December 16, the Council for Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization (WTO) issued a report recommending that the General Council extend the deadline by which the WTO would...more

Alston & Bird

Health Care Week in Review: CMS Issues Prior Authorization Proposed Rule

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Akin Gump Strauss Hauer & Feld LLP

USTR Announces Support for Extending TRIPS Waiver Expansion Discussions and Launches USITC Investigation

Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more

McDonnell Boehnen Hulbert & Berghoff LLP

Status of Proposed Extension of TRIPS Waiver in WTO

It is often observed (or asserted) that a fair compromise in a dispute has likely been reached when both sides are not particularly happy about it.  This is not always the case, of course, and is more likely not to be the...more

A&O Shearman

Southern District Of New York Dismisses Putative Class Action Against Pharmaceutical Company For Failure To Adequately Allege...

A&O Shearman on

On September 12, 2022, Judge J. Paul Oetken of the United States District Court for the Southern District of New York dismissed with prejudice a putative class action asserting claims under the Securities Exchange Act of 1934...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 86

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. ...more

Epstein Becker & Green

Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care

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For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19...more

Sunstein LLP

WTO Authorizes Partial TRIPS Waiver For Covid-19 Vaccines

Sunstein LLP on

As we previously reported, some members of the World Trade Organization (WTO), including India and South Africa, had called for a waiver of intellectual property enforcement on COVID-19 pandemic-related diagnostic kits,...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: Recent Developments in Criminal Antitrust for Busy Corporate Counsel - Q1 2022

Since the last edition of the QCC, there has been a series of dramatic developments in the criminal antitrust enforcement space in the U.S. from the Department of Justice’s Antitrust Division (Division)....more

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