News & Analysis as of

Pharmaceutical Industry Food and Drug Administration (FDA) Vaccinations

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

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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

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

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

Goodwin

FDA Approves Moderna’s mRESVIA Vaccine

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​​​​​​​On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused...more

Troutman Pepper

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

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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

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

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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

Harris Beach PLLC

Medical and Life Sciences: Year in Review 2022

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From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...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

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

Wilson Sonsini Goodrich & Rosati

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

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

Morrison & Foerster LLP - Class Dismissed

Pleading And Preemption: Immunization Against Vaccine Products Liability Claims

In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM),...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Arbutus and Genevant Sue Moderna in First Significant Patent Infringement Lawsuit in the mRNA Space

In the first major patent infringement lawsuit in the mRNA space, on February 28, 2022, Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) sued Moderna, Inc. and ModernaTX, Inc. (collectively...more

Alston & Bird

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

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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

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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Alston & Bird

FDA Suspends Non-Mission-Critical Domestic and Foreign Inspections – Medical Products Supply Chain Week in Review

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Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more

Alston & Bird

FDA Authorizes Booster Dose for Adolescents – Medical Products Supply Chain Week in Review

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Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

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In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

Alston & Bird

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

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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

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