If Congress wants to curtail drug shortages, it needs to put some teeth in a PDUFA V provision that requires companies to notify the FDA six months in advance of events that could lead to a shortage, according to a panel at the annual meeting of the American Society of Clinical Oncology (ASCO).
The jury may be out a while on whether the Jumpstart Our Business Startups Act (JOBS Act) will be able to deliver on its promise of helping emerging-growth biotechs attract the capital they need to turn R&D into marketable drugs.
PharmAthene Inc., the jilted pharma left at the merger altar six years ago by SIGA Technologies Inc., is in line for a court-ordered payback, but it may have to wait through yet another court proceeding before it gets satisfaction.
WASHINGTON – With none of the debate seen in the Senate over a string of amendments, the House overwhelmingly voted Wednesday to suspend the rules and pass its revised PDUFA package that purportedly will save the federal government $370 million over the next decade.
WASHINGTON – Biopharma has cause to celebrate as PDUFA V rolled through the Senate Thursday with little in the way of fireworks. The FDA Innovation and Safety Act (FDASIA), S. 3187, passed the Senate 96-1 after a full day of debate on various amendments.
A singular focus on HIV/AIDS and a lag in translating medical discoveries into approvable medicines could be keeping the U.S. from getting its money's worth from R&D aimed at addressing the most pressing global health needs.
Even though Pfizer Inc.'s Vyndaqel already is approved in Europe, getting U.S. approval for the orphan drug on the strength of a single pivotal trial is looking like it could be an uphill battle.