WASHINGTON - A Medicare advisory panel Wednesday said evidence backed the use of Amgen Inc.'s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Centocor Ortho Biotech Products LP's Procrit (epoetin alfa) as therapies to manage anemia in dialysis patients with chronic end-stage renal disease (ESRD). (BioWorld Today)
GAITHERSBURG, Md. - Shares of Cell Therapeutic Inc. plunged 48.3 percent Monday after an FDA advisory panel voted unanimously that the Seattle-based firm's data were insufficient for an accelerated approval of Pixuvri (pixantrone) as a single-agent treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma who have received two or more prior lines of therapy. (BioWorld Today)
Investors were more than relieved Tuesday on the news that Icagen Inc.'s ICA-105665 met its primary endpoint in a Phase IIa study measuring the drug's ability to reduce the photic-induced epileptiform EEG response in patients with epilepsy. (BioWorld Today)
The FDA told MannKind Corp. in a complete response letter that before the agency could approve the firm's inhaled diabetes drug Afrezza (insulin human rDNA origin), regulators needed more information about its clinical utility and comparison data about the newer version of the drug's inhaler device vs. the one tested in pivotal clinical trials. (BioWorld Today)
WASHINGTON - After headlines emerged Wednesday about new data linking prolonged bisphosphonate use to an increased risk of atypical femur fractures, the FDA rushed to assure prescribers and the public that the agency has yet to find a clear connection. (BioWorld Today)
