In unanimous decision, court finds Amgen patent offered persons skilled in the art “little more than advice to engage in ‘trial and error.’” Lawyers say the ruling prevents function claims from monopolizing a therapeutic target and retains status quo on enablement requirement.
The US Supreme Court unanimously affirmed an appeals court ruling that Amgen, Inc.’s patents claiming to cover all antibodies that bind to the PCSK9 protein are invalid. The decision is a relief for many in the biopharma sector who were concerned that a finding for Amgen could deter innovation.
Amgen alleged that Sanofi and Regeneron Pharmaceuticals, Inc.’s anti-PCSK9 antibody Praluent (alirocumab) infringes two patents that cover a...
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
