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.
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.