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.
WASHINGTON – Fears of another heparin fiasco and the reality of stolen and counterfeit drugs entering the U.S. supply chain have fueled several new bills in Congress, but the wheels of the legislative process are turning slowly.
Forest Laboratories Inc. got hesitant, but positive, support Thursday for approval of its inhaled aclidinium bromide as a twice-daily treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD).
Vivus Inc. scored a near knockout in its second bout before the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) with its weight-loss contender Qnexa.
WASHINGTON – Flexing its regulatory discretion, the FDA curbed two critical cancer drug shortages by speeding approval of a new source for preservative-free methotrexate and allowing the temporary importation of Lipodox as an alternative to Doxil.
WASHINGTON – Armed with more information about cardiovascular and teratogenic risks, as well as a less restrictive risk evaluation and mitigation strategy (REMS), Vivus Inc. is prepared for a second performance before the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
The 800-pound gorilla in the Patent and Trademark Office (PTO) hearing on genetic diagnostic tests was Myriad Genetics Inc. – even though the Salt Lake City-based company wasn't on the agenda.
Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the government. That principle has served the nation well for nearly 250 years. But now the FDA is seeking a congressional blessing to change it, under the guise of drug safety. Testifying before a House subcommittee last week, the FDA’s Janet Woodcock noted the stress placed on the agency because it bears the burden of proof when it comes to the...
