As expected by most analysts, Forest Laboratories Inc. and Nycomed GmbH Monday night received a complete response letter for their chronic obstructive pulmonary disease (COPD) drug Daxas (roflumilast). (BioWorld Today)
SILVER SPRING, Md. - An FDA panel Wednesday in a 16-to-1 vote, with one abstention, rejected NicOx SA's naproxcinod, a cyclooxygenase-inhibiting nitric oxide-donating compound, as a treatment to relieve the signs and symptoms of osteoarthritis. (BioWorld Today)
WASHINGTON - Perhaps it was the hangover from Thursday's "2:45 p.m. Wall Street crash," in which the Dow Jones Industrial Average spiraled nearly 1,000 points before minutes later somewhat bouncing back, that had Questcor Pharmaceuticals Inc.'s investors jittery Friday, despite an FDA panel's support for approval of the company's Acthar Gel (repository corticotrophin injection) as a therapy for infantile spasms. (BioWorld Today)
Investors Thursday drove shares of Keryx Biopharmaceuticals Inc. up 6.8 percent after the firm said it started a short-term Phase III study evaluating Zerenex (ferric citrate), an iron-based phosphate binder, as a treatment for hyperphosphatemia in dialysis patients with end-stage renal disease (ESRD). (BioWorld Today)
