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Vaccinations Prescription Drugs

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

Skadden, Arps, Slate, Meagher & Flom LLP

Make America Healthy Again Commission Aims To Combat Chronic Disease and Reform Health Policies

On February 13, 2025, at the swearing-in of Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., President Donald Trump signed Executive Order “Establishing the President’s Make America Healthy Again...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

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On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 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

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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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

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

Alston & Bird

Health Care Week in Review: Texas Judge Blocked FTC Rule Banning Noncompetes; Biden Administration Announced $1.4 Billion for HIV...

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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

Health Care Week in Review: HHS Finalizes 340B ADR Rule; House and Senate Hold Hearings on President’s FY 2025 HHS Budget

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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

Religious Institutions Update: January 2024

Holland & Knight LLP on

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

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #3

McGuireWoods Consulting on

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...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

Alston & Bird

Health Care Week in Review: CMS Announces Details to Pay Drug Costs on Installment Plan

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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

Holland & Knight Health Dose: June 6, 2023

Holland & Knight LLP on

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

King & Spalding

Major Shift in Best Price Proposed in Grab Bag of MDRP Reforms

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The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2023

Tens of millions of us endured the annual paper chase of tracking down and sorting through receipts and forms so we could file income tax returns. Here’s another paper exercise that promises more personal benefits than just...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

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

White & Case LLP on

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

Faegre Drinker Biddle & Reath LLP

Failure to Comply with Lone Pine Order Results in Dismissal of Over 1,000 Cases in Zostavax MDL

Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of...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

Holland & Knight LLP

Holland & Knight Health Dose: October 18, 2022

Holland & Knight LLP on

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

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