Legal

Model N's Jesse Mendelsohn examines the growing stakes surrounding the 340B Drug Pricing Program — and how claims data, rebate models and simmering legal challenges are influencing manufacturer response and strategy today.

The Trump administration adds nine drugmakers to its Most Favored Nation pricing program, GSK advances its dual-antigen mRNA flu vaccine into Phase III, and Simcere Zaiming licenses its tri-specific antibody Sim0660 to Roche for up to $1.53 billion.

James LaValle, chair of the International Peptide Society, notes how the advisory committee's favorable vote on peptides for the 503A Bulks List was a meaningful step without constituting approval.

Why pricing pressure, policy volatility and supply-chain risk are pushing drugmakers toward greater cost and portfolio discipline, without losing sight of investment in innovation.

In today's Pharmaceutical Executive Daily, a new report finds U.S. rare disease biotech investment rebounding after FDA's Priority Review Voucher program renewal, President Trump signs an executive order narrowing the recommended childhood vaccine schedule, and BeOne Medicines and Revolution Medicines announce a multi-part oncology collaboration.

President Trump signs an executive order shrinking the recommended childhood vaccine schedule from 18 diseases to 11, and calls for the MMR shot to be split into three separate injections.

In today's Pharmaceutical Executive Daily, an antitrust attorney weighs the legal risks of a hypothetical AstraZeneca-Bristol Myers Squibb merger, Eli Lilly beats Wall Street estimates on soaring Mounjaro and Zepbound sales and raises its full-year guidance, and the FDA approves Moderna's first mRNA-based flu vaccine for adults 50 and older.

Ron Lanton, senior partner at Lanton, Lanton & Sosa Law, discusses the legal risks associated with a hypothetical AstraZeneca–Bristol Myers Squibb merger.

In today's Pharmaceutical Executive Daily, a senior source denies reports of merger talks between AstraZeneca and Bristol Myers Squibb, CSPC Pharmaceutical and AstraZeneca form a joint venture for biologics manufacturing in China, and a feature examines how U.S. Patent and Trademark Office policy changes are slowing patent challenges for generic and biosimilar drugmakers.

A senior source claims there are no discussions underway between AstraZeneca and Bristol Myers Squibb over a potential combination.

Recent changes at the U.S. Patent and Trademark Office are making it harder to challenge pharmaceutical patents, raising concerns that slower generic and biosimilar competition could undermine efforts to lower drug costs while strengthening protections for brand-name innovators.

FDA's advisory committee voted 10 to 3 that efficacy data from the Ignyte study is evaluable and clinically meaningful.

An FDA advisory panel voted to recommend six of seven unapproved peptides for compounding access, raising concerns about its newly appointed members.

In this episode, Ron Lanton argues that healthcare's next constraint isn't capital or technology but rather people.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center,argues that closing the gap between federal reshoring policy and manufacturer investment requires more than incentives.

In today's Pharmaceutical Executive Daily, Novo Nordisk sues Eli Lilly over GLP-1 advertising it calls misleading, President Trump announces a phased tariff plan for imported generic drugs, and a new commentary argues pharma's AI investment is missing the areas of drug discovery where it matters most.

President Trump announces a zero tariff on imported generic drugs through August 2026 before a phased escalation to 200% by 2029.

FDA issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.

FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

A U.S. House committee has launched national security investigations into Merck, AbbVie, Eli Lilly, Pfizer, and Bristol Myers Squibb over their clinical trial operations in China, seeking answers by July 17 on data protection, military hospital ties, and trial sites in Xinjiang.

In today's Pharmaceutical Executive Daily, the Supreme Court unanimously rules in favor of Hikma Pharmaceuticals in its patent dispute with Amarin over Vascepa, Pfizer licenses Chai Discovery's generative AI platform, and C.K. Wang argues that high-quality real-world data represents the most promising path forward for closing persistent gaps in ovarian cancer care.

The Supreme Court ruled unanimously in favor of Hikma Pharmaceuticals, finding its generic Vascepa did not infringe Amarin's patents under the skinny-label pathway, a decision that strengthens legal protections for generic manufacturers.

A federal court’s decision to temporarily allow continued mail distribution of mifepristone underscores the ongoing legal and regulatory uncertainty surrounding abortion access.

A federal court setback on childhood vaccine policy has left the White House weighing legal options against electoral risks, as it navigates pressure from its MAHA base alongside broader public support for immunization programs.

Britain’s MHRA intensifies enforcement against illegal weight-loss drugs, seizing nearly 2,000 doses and equipment amid rising global demand for obesity treatments.