WASHINGTON – Stop searching for the perfect way and just do it, a coalition of drugmaker, distributor and pharmacy groups told a House subcommittee last week as it pushed for a uniform, nationwide track-and-trace system for prescription drugs that's practical and feasible.
WASHINGTON – The practice of accelerated approval needs to live up to what the law allows, a House subcommittee was told Thursday as it considered a number of issues riding the coattails of PDUFA.
Hoping to unlock much-needed access to the public market for emerging growth companies, the House expects to pass a legislative package later this week that would remove some of the barriers that have all but shut the initial public offering (IPO) door to small biotechs.
WASHINGTON – With the misuse and abuse of drugs becoming the leading cause of accidental death in the U.S., Congress is looking for ways to curb the use of some prescription painkillers and insomnia/anxiety drugs.
Rather than banking on its future royalties of Cimzia and Mircera, Nektar Therapeutics Inc. cashed them in for $124 million to pay down its $215 million convertible debt that comes due in September.
WASHINGTON – After months and months of negotiating the provisions of PDUFA V with the FDA, biopharma is holding its collective breath as the user fee agreement wends its way through the congressional process.
WASHINGTON – The randomized, controlled clinical trial that is today's gold standard for drug research needs to take a backseat to trials designed for real-world conditions with endpoints that are important to patients.
