Highlights of weekly biotech stock moves

Amgen Inc. (NASDAQ:AMGN) lost $0.59 to $52.94 last week on a trio of regulatory decisions. On Wednesday, CMS proposed not to issue a National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs) to treat anemia in patients with chronic kidney disease (CKD). The proposal mean the agency would not set standards for ESAs that could have reduced access to the drugs. Amgen markets Aranesp darbepoetin alfa for cancer and renal indications and Epogen epoetin alfa for chronic renal failure (see B10).

Meanwhile, EMA's CHMP issued a negative opinion for an MAA to expand the label of the company's Vectibix panitumumab to include combination with chemotherapy to treat metastatic colorectal cancer in patients with wild-type K-Ras (KRAS) tumors. CHMP questioned the relevance of a "modest increase" in progression-free survival (PFS) given a lack of improvement in overall survival (OS) and quality of life (see B10)...