Legal

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.

Following Pfizer's lawsuits, Novo Nordisk enhanced its acquisition offer for Metsera, resulting in Pfizer also sending an enhanced offer.

Pfizer's lawsuits come after Novo Nordisk proposed an unsolicited acquisition proposal to Metsera.

Dr. Jeanne Marrazzo's firing highlights concerns over political interference in health research and vaccine safety advocacy amid whistleblower allegations.

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

Ron Lanton, partner, Lanton Law, warns that recent changes to federal vaccine recommendations could trigger extensive litigation as insurers, providers, and patients face new access and coverage challenges.

The directive calls for building a Strategic Active Pharmaceutical Ingredients Reserve, updating the essential medicines list, and prioritizing US-made APIs.

A new two-phase initiative aims to streamline facility approvals, reduce reliance on foreign pharmaceutical production, and bolster domestic supply chain resilience amid rising tariffs and reshoring investments.

The settlement ends US mRNA patent disputes involving COVID-19 and influenza vaccines, while positioning GSK for additional payments and global royalty benefits if BioNTech’s acquisition of CureVac closes.

The Regeneron litigation highlights that donations routed through independent entities are not immune from challenge, especially if the government believes they are effectively covering a patient’s co-pay for a specific product.

Q&A with Model N's Michael Grosberg drills deeper into the new US drug pricing directives, including challenges in implementation, the potential unintended consequences, and how these actions could spark the shift to outcomes-based contracting in healthcare.