Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Amgen Inc. (NASDAQ:AMGN) gained $0.02 to $58.01 last week after CMS decided not to issue a National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs) to treat anemia in patients with chronic kidney disease (CKD). In the U.S., Amgen markets Aranesp darbepoetin alfa for cancer and renal indications and Epogen epoetin alfa for chronic renal failure.
Meda AB (SSE:MEDAA) lost SEK0.30 to SEK65.70 last week after FDA accepted for filing an NDA for Dymista azelastine/fluticasone to treat seasonal allergic rhinitis in patients aged 12 years and up. The PDUFA date for the application, which was submitted in April, was not disclosed.
Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) fell $1.62 (12%) to $11.60 on Tuesday after FDA extended the PDUFA date from July 28 to Oct. 28 for Exparel extended release bupivacaine for post-operative pain management. The company said it submitted undisclosed additional information at the agency's request. Pacira was off $2.15 (17%) to