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Coronavirus/COVID-19 › Vaccinations › Prescription Drugs

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 -
Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

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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

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

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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

Holland & Knight LLP

Religious Institutions Update: January 2024

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Failure to Extend Extracurricular Opportunities to Parochial School Students Violates Free Exercise In Religious Rights Foundation of Pa. v. State College Area Sch. Dist., No. 23-CV-01144, 2023 WL 8359957 (M.D. Pa. Dec. 1,...more

Troutman Pepper Locke

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

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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

Holland & Knight LLP

Holland & Knight Health Dose: June 6, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...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

McGuireWoods Consulting

Washington Healthcare Update - February 2023

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This Week in Washington: President Biden announces ending date of COVID-19 PHE, House begins investigations into COVID-19 origins; State of the Union scheduled for Feb. 7...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

Alston & Bird

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

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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

Akin Gump Strauss Hauer & Feld LLP on

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

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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

Holland & Knight LLP

Holland & Knight Health Dose: October 18, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Alston & Bird

Health Care Week in Review: CMS Issues a Request for Information to Gather Public Input on Accessing Healthcare and Related...

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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

Holland & Knight LLP

With Inflation Reduction Act Signed, Other Health Policy Issues Ahead for Congress

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Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more

Alston & Bird

Health Care Week in Review: HHS Announced the Distribution of $49 Million to Organizations

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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

Alston & Bird

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

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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

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #4

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This Week in Washington: Senate Questions Supreme Court Justice Nominee Ketanji Brown Jackson...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 77

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COMPETITION & STATE AID - State Aid- European Commission publishes Annual Single Market Report 2022 - On 22 February 2022, the European Commission published the Annual Single Market Report 2022, which sets out, in...more

McGuireWoods Consulting

Washington Healthcare Update - March 2022

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This Week in Washington: President Biden Reiterates Healthcare Priorities and Announces Initiatives in his State of the Union Address...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #3

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Congress - The House is in a district work period this week. The Senate is in a state work period this week. Senate - Short-Term Continuing Resolution Passes Senate and is Signed by the President - On Feb. 18,...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #2

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This Week in Washington: Continuing Resolution Moves Forward and Senate Sets Up Vote on FDA Commissioner Nomination this Week...more

Alston & Bird

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

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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

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

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