Legal

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.

BioNTech filed a patent infringement lawsuit against Moderna alleging unauthorized use of patented mRNA technology.

Following the decisions=, the European Commission decided to close a long-running antitrust investigation

The indictment of AstraZeneca’s former China chief Leon Wang marks a significant development in Beijing’s probe into drug importation and insurance practices, adding legal pressure even as the company works to stabilize its business in the region.

The shifting landscape amid China's biotech rises presents both opportunities and geopolitical challenges for growth strategies.

FDA Commissioner Marty Makary’s warning against mass-marketed copycat drugs escalated the regulatory and legal clash over compounded oral GLP-1 products.

Public Citizen’s lawsuit highlights broader concerns over government transparency and oversight in pharmaceutical policy.

The Trump administration has announced new negotiated Medicare prices for a second wave of blockbuster treatments, yielding an estimated $12 billion in savings for 2027, when compared to Medicare’s 2024 net spending.

Tesaro and AnaptysBio engage in legal battles over alleged breaches of their 2014 partnership agreement regarding Jemperli.