The controversial Promoting and Respecting Economically Vital American Innovation Leadership Act was finally voted by the Senate Judiciary Committee after the markup was postponed multiple times since the summer.
Concerns Over PREVAIL Act Persist, Even With Amendment To Shield Off-Patent Drugs
The Bill Received A Close Vote Of 11-10 By The Senate Judiciary Committee
Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.
More from Regulation
• By
Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
• By
The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.
• By
Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
More from Generics Bulletin
• By
Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.