Back in June, Amgen said it was eyeing a U.S. application for its cancer-fighting viral vaccine in the short term but would be looking outside the U.S. as well. After submitting its candidate to the FDA in July, the company now says it's turned over a marketing authorization application to the European Medicines Agency for the melanoma candidate.
Ivabradine, a heart rate-reducing drug from Servier and Amgen, failed to beat placebo in a huge study of patients with coronary artery disease, potentially clouding its future on two continents.
Amgen has taken another big step in its head-to-head race with Sanofi and Regeneron, filing its application for the prospective cholesterol blockbuster evolocumab and backing it up with more positive data from the latest in a long string of major clinical studies.
Amgen successfully wrapped its second Phase III study for AMG416, its late-stage drug for secondary hyperparathyroidism that's now one final study away from a prospective regulatory filing.
A Phase III late-stage myeloma miss for Amgen's Kyprolis didn't shock analysts, who said the failure was more or less expected when the company announced trial results Wednesday. But without proof that the med prolongs life in those patients, getting Kyprolis by European regulators could be a tough sell.
Amgen is recalling 9 lots of an anemia drug from 14 countries outside of the U.S. after syringes were found to have cellulose and polyester particles in them. The recall comes at a tough time for Amgen's manufacturing operations, which were just targeted for big cuts to prepare the company for future competition to a key product.
Amgen put out the word Monday that adding Kyprolis to combo therapy with Celgene's Revlimid beat out the Revlimid combo alone in melanoma patients who had relapsed.
Express Scripts has struck again. The pharmacy benefits manager is barring another 25 drugs, including some aging heavyweights like Amgen's anemia drugs Aranesp and Epogen, and newer meds such as the controversial painkiller Zohydro, made by Zogenix.
Amgen put out the word Monday morning that Kyprolis--provided in a combo package with Celgene's Revlimid--beat out Revlimid alone in a head-to-head Phase III study for multiple myeloma, hitting the primary endpoint and offering the Big Biotech a shot at expanding its franchise for the drug at a critical moment in the company's history.
Amgen is cutting up to 2,900 jobs, and the ax-wielding will fall heavily on manufacturing and R&D sites in Colorado and Washington, whose futures were already dim.