The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

In a 5-4 decision, the high court says a Chapter 11 bankruptcy plan provision releasing the Sackler family from future liability is not allowed, a decision that could spur a bolus of personal injury trials if another reorganization plan settling thousands of claims cannot be reached.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."

Drug maker pursuing novel approach to establishing that contract pharmacies are improperly taking ‘title’ to 340B-discounted drugs, leading to diversion, which is prohibited by law.

While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

“Access Plans” are the US NIH’s new idea to address calls to take a more hands-on role in regulating the prices of products developed with taxpayer funding, but what the policy would actually mean for prices is hard to pin down, and that is probably deliberate.

Did Samsung Bioepis and Biogen choose early US access for their Lucentis biosimilar in exchange for postponing launch in other markets? That’s what Italy’s competition authority believes, as it investigates the biosimilar sponsors and originator companies Genentech and Novartis.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Apparently months after his actual detention, news has finally surfaced that a key researcher behind China's rapid development of a homegrown COVID-19 vaccine is said to have "severely violated" Communist Party rules and regulations and is the subject of a probe for possible corruption.

The DC Circuit Court agrees with an earlier appeals court ruling that the law does not prohibit manufacturers from setting the terms of their 340B outpatient drug discounts to contract pharmacies.

The R&D-based pharma industry has welcomed the “more careful and considered approach” taken by EU ministers to the European Commission’s proposed compulsory licensing system, but says there is room for further improvement.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

US Federal Trade Commission says the policy would enhance its ability to detect reverse payment settlements between pharmaceutical companies that raise antitrust concerns.

A bill that would prevent product hopping was estimated to save US taxpayers $3bn by the US Congressional Budget Office, increasing the likelihood it could be enacted to help pay for other congressional priorities.

While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

Proposed rule would not require price concessions in the interest of balancing enhanced access with protecting the ‘viability and sustainability of a product’ in the market.

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Industry groups say the initiative will undermine innovation and the competitiveness of European companies, impeding Europe's ability to tackle future crises effectively.

The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions. 

US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.