News & Analysis as of

Pharmaceutical Industry

Arnall Golden Gregory LLP

Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more

Epstein Becker & Green

DOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights Violations and...

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On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more

Mayer Brown

Big Firms, Be Careful What You Say: First UK Competition Disparagement Decision Puts Large Companies On Notice

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OVERVIEW - The UK Competition and Markets Authority (“CMA”) has recently published a decision accepting commitments from Vifor Pharma (“Vifor”). This brings to a close an unprecedented abuse of dominance investigation...more

Goodwin

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

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Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more

Goodwin

Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation

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On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099...more

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

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The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

Dacheng

China Monthly Antitrust Update: June 2025

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This monthly report outlines key developments in China’s antitrust sector for June. The following events merit special attention: SAMR Seeks Comments on Provisions for Curbing Acts of Abusing Administrative Power to Eliminate...more

Stark & Stark

Guide to Ozempic/Wegovy Vision Loss Lawsuits and Settlements

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What types of eye injuries does Ozempic/Wegovy cause? Ozempic/Wegovy are two of the most common weight-loss medications known as GLP-1 drugs. Other  GLP-1 drugs include Mounjaro, Rybelsus, Saxenda, Victoza, Trulicity, and...more

Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

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The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

Eversheds Sutherland (US) LLP

Partial Implementation of the US - UK Economic Prosperity Deal

On 16 June 2025, US President Donald Trump signed an executive order confirming and implementing parts of the US-UK Economic Prosperity Deal (“EPD Order”), following the announcement at the G7 Summit earlier this week....more

Hogan Lovells

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

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The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

Goodwin

Delaware Court Awards More Than $180 Million for Breach of Commercially Reasonable Efforts Obligation in Drug Development...

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On June 11, 2025, the Delaware Court of Chancery found Alexion Pharmaceuticals liable for more than $180 million in damages to former stockholders of Syntimmune, Inc., following the Court’s September 2024 ruling that Alexion...more

McDermott Will & Emery

This Week in 340B: June 10 – 16, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more

Knobbe Martens

Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma

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On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

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Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

Mintz - Health Care Viewpoints

OIG Favorable Advisory Opinion on Physician Practice’s Arrangement with Telehealth Platform and Recent Corporate Practice of...

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more

Ankura

Reshaping Global Business Strategy: Where Will We Land on Tariffs

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Dive into the world of global trade in the latest episode of The Impact Exchange with John Frehse as he is joined by trade expert Kate Kalutkiewicz!...more

Gardner Law

New DOJ Rule Restricts Deidentified Data Transfer

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No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer - This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized,...more

A&O Shearman

Federal Circuit Affirms District Court’s Claim Construction Of “Branched Alkyl” In mRNA Vaccine Patent Dispute

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On June 4, 2025, the United States Court of Appeals for the Federal Circuit (Judges Taranto, Chen, and Hughes) affirmed the District of Delaware’s claim construction in a patent infringement dispute involving lipid components...more

A&O Shearman

Ninth Circuit Panel Affirms Ruling That “Unclean Hands” Does Not Bar Antitrust Standing

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On May 23, 2025, a panel for the United States Court of Appeals for the Ninth Circuit addressed the application of the “unclean hands” doctrine to antitrust standing. PharmacyChecker.com LLC v. LegitScript LLC, No. 24-2697...more

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

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Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - June 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

WilmerHale

Federal Circuit Patent Watch: An Enabling Anticipatory Prior Art Reference Need Only Enable a Single Embodiment of the Claim

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Precedential and Key Federal Circuit Opinions - ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. [OPINION] (2023-2357, 06/04/2025) (Taranto, Chen, Hughes) - Taranto, J. The Court affirmed the district court’s claim...more

Latham & Watkins LLP

FDA Color Additive Scrutiny Expands to Pharmaceuticals

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FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more

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