WASHINGTON – As a congressional conference committee knits together the Senate and House versions of a PDUFA package, pressure is mounting for it to darn a few holes – such as the lack of an effective track-and-trace system to reinforce the drug supply chain.
The biotech industry is hoping the Supreme Court will do what Congress hasn't been able to do – give companies a fighting chance against class-action shareholder lawsuits claiming "fraud on the market."
WASHINGTON – The Small Business Innovation Research (SBIR) program is about to get a lot more competitive. And that should improve the quality of proposals and spur innovation in a program that provides much-needed funding to small biotechs, the Small Business Administration (SBA) said.
WASHINGTON – Whether a biosimilar by any other name would be prescribed as readily as the brand biologic it mimics is the budding debate as the FDA moves forward on the biosimilar pathway.
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.
