News & Analysis as of

Food and Drug Administration (FDA) Pharmaceutical Industry Prescription Drugs

Goodwin

Alvotech and Teva Announce FDA Approval of Additional Presentation for Ustekinumab Biosimilar

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On October 22, 2024, Alvotech and Teva announced that SELARSDI™ (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion....more

Morrison & Foerster LLP

Cases to Watch: Gilead Life Sciences v. Superior Court - October 2024

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The Supreme Court of California is gearing up to decide an important question for the future of product liability law: Do drug manufacturers have a duty to innovate? In other words, does a manufacturer of a non-defective drug...more

Epstein Becker & Green

Exemptions from the Drug Supply Chain Security Act Enhanced Drug Distribution Security Requirements

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On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution...more

Cooley LLP

FDA Finalizes Guidance on Use of Part 11 Electronic Systems, Records and Signatures in Clinical Investigations

Cooley LLP on

On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products and new animal drugs. The...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 6, October 2024

Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more

Goodwin

Federal Circuit Denies Injunction Pending Appeal After Amgen Beat Preliminary Injunction for Biosimilar Aflibercept

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As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved...more

Hogan Lovells

FDA lists top 10 artificial intelligence regulatory concerns

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Last week, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials published a “Special Communication” in JAMA titled, “FDA Perspective on the Regulation of Artificial...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2024 #3

News Briefs - FTC Finalizes Providers' Reporting Rules Prior to M&A - The Federal Trade Commission finalized changes to a rule that will require healthcare companies, including hospitals and providers, to provide more...more

DLA Piper

Teva Ordered to Delist Inhaler Patents From FDA Orange Book

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In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more

Alston & Bird

Health Care Week in Review: HHS Announced Updates on Response to IV Fluid Shortage and 233 Members Call on House Leadership to...

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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

Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA

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On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more

Venable LLP

Accord BioPharma’s Stelara® Biosimilar Imuldosa™ Approved by FDA

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On October 10, 2024, the FDA approved Accord BioPharma’s Imuldosa™ (ustekinumab-srlf), the fifth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa™ was developed by Dong-A ST in collaboration with...more

Polsinelli

FDA Issues Exemptions from November 27, 2024 Compliance Deadline for Updated DSCSA Requirements

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On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements.  The exemptions followed...more

Hissey, Mulderig & Friend, PLLC

Ozempic Weight Loss Users at Risk of Gastroparesis and Other Stomach Problems, New Study Reveals

A recent study published by the Journal of the American Medical Association (JAMA) found that patients taking the drugs Ozempic (semaglutide) and Wegovy (liraglutide) for weight loss were more than three-times more likely to...more

Arnall Golden Gregory LLP

A Potential Poison Pill for Dosage Claims

On August 14, 2024, the US District Court for the District of Delaware entered final judgment in Wyeth—a patent infringement case relating to pharmaceuticals for treating non-small cell lung cancer (“NSCLC”)—vacating a jury...more

McDermott Will & Emery

Tirzepatide Shortage Resolved

McDermott Will & Emery on

On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

Goodwin

Fresenius and Formycon Receive EC and FDA Approval of Ustekinumab Biosimilar

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On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™...more

Nelson Mullins Riley & Scarborough LLP

A Rock and a Hard Place - The Third Circuit's Recent Fosamax Preemption Decision

Last month, the Third Circuit issued another appellate opinion in the long-gestating In re Fosamax litigation (3d Cir Sept. 20, 2024, – F. 4th, 2024 WL 4247311). The litigation, now well into its second decade, involves...more

Hissey, Mulderig & Friend, PLLC

Ozempic, Other Diabetes-Weight Loss Drugs Linked to 162 Deaths, According to FDA Data

Ozempic and other diabetes-weight loss drugs have been linked to at least 162 deaths and 10,000 cases involving “serious” injuries since 2018, according to data from the U.S. Food and Drug Administration (FDA)....more

Venable LLP

Fresenius Kabi and Formycon Announce Approval of Stelara® Biosimilar Otulfi™ in the U.S. and E.U.

Venable LLP on

On September 27, 2024, the FDA approved a fourth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab): Fresenius Kabi and Formycon’s Otulfi™ (ustekinumab-aauz). Fresenius and Formycon announced Oltufi™’s...more

Oberheiden P.C.

What Patients and Families Should Know About the Suboxone Multidistrict Litigation (MDL)

Oberheiden P.C. on

Hundreds of federal Suboxone lawsuits filed across the country against Indivior, Inc. have been consolidated into multidistrict litigation (MDL) instead of having a Suboxone class action lawsuit. This MDL is in the United...more

Morgan Lewis - As Prescribed

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration...more

Goodwin

Recent Biosimilar Approvals By the FDA

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Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN...more

Goodwin

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

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​​​​​​​On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product”...more

Alston & Bird

Health Care Week in Review: House Energy & Commerce Committee Held a Markup of 16 Bills; HRSA Demands Johnson & Johnson Cease 340B...

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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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