Popular, Coronavirus/COVID-19, Pharmaceutical Industry

False Claims Act Settlements to Know from the First Half of 2025

Bass, Berry & Sims PLC on 8/12/2025

With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on 5/27/2025

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

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

Goodwin on 9/3/2024

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 Week in Review: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

Alston & Bird on 2/26/2024

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

Health Care Week In Review: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation

Alston & Bird on 9/6/2023

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

Health Care Week in Review: Emerging Technology Coverage Pathway, Long COVID Advisory

Alston & Bird on 6/26/2023

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

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

Jones Day on 3/22/2023

This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

The State of Biosimilars in 2023

Venable LLP on 3/17/2023

It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more

Washington Healthcare Update - March 2023

McGuireWoods Consulting on 3/7/2023

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

Hot Topics in Health Care January 2023

Burr & Forman on 1/18/2023

Court Remands Remedy for Unlawful 340B Rule to HHS - On January 10, 2023, the DC District Court remanded the issue of how to remedy five years of underpayments to 340B hospitals to the Department of Health and Human...more

Health Care Week in Review: Congress Passes Omnibus, HHS Releases Hospital Data

Alston & Bird on 12/26/2022

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

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

Alston & Bird on 12/12/2022

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

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on 5/11/2022

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

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

Morrison & Foerster LLP on 5/10/2022

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

Alston & Bird Health Care Week in Review - May 2022 #1

Alston & Bird on 5/9/2022

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

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Wilson Sonsini Goodrich & Rosati on 4/26/2022

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

Washington Healthcare Update - March 2022 #3

McGuireWoods Consulting on 3/22/2022

This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022...more

Alston & Bird Health Care Week in Review - February 2022 #2

Alston & Bird on 2/15/2022

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

Weekly Update for Government Contractors and Commercial Businesses – February 2022

PilieroMazza PLLC on 2/4/2022

DOJ Recovers Over $5.6 Billion From Fraud and False Claims Act Matters in FY 2021: 6 Key Takeaways - On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it had recovered more than $5.6 billion in Fiscal...more

mRNA Patent and Competitive Landscape: 2021 Year in Review and 2022 Outlook

Rothwell, Figg, Ernst & Manbeck, P.C. on 1/3/2022

In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more

Delaware Federal Court Dismisses Shareholder Derivative Suit Concerning Lack of Board Diversity

Goodwin on 12/23/2021

Delaware Federal Court Dismisses Shareholder Derivative Suit Concerning Lack of Board Diversity; California Federal Court Dismisses Shareholder Class Action Against Sorrento Therapeutics Regarding COVID-19 Treatment; Delaware...more

Alston & Bird Health Care Week in Review - December 2021 #2

Alston & Bird on 12/13/2021

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

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

Jones Day on 12/9/2021

COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

Pfizer and BioNTech to Request Approval for Vaccine Use in 12-to-15-Year-Olds – Medical Products Supply Chain Week in Review

Alston & Bird on 12/6/2021

In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more

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

Maynard Nexsen on 12/3/2021

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

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