Big biologic makers line up on opposite sides of dispute between Amgen and Sanofi over whether Amgen’s Repatha patents cover analogous antibodies with the same functional characteristics.
The biopharmaceutical industry is in intense conflict over a case that could determine how broadly a patent can cover a cutting edge invention. More than a dozen companies have taken opposite sides in the dispute between Amgen, Inc. and Sanofi over their PCSK9-targeting antibodies.
The US Supreme Court is to hear oral argument in the case, Amgen v. Sanofi, on 27 March. The case...
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
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.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
