A month ago, Amgen and AstraZeneca were confidently rolling up data from three highly touted late-stage studies on the psoriasis drug brodalumab for a new drug application that was widely viewed as a shoe in at the FDA. But late Friday evening, as the industry was heading out for a long Memorial Day weekend, Amgen abruptly said it was pulling out of the long-running collaboration on the high-profile IL-17 program after evaluating the likely commercial impact it would face in light of the suicidal thoughts some patients reported during the studies.
Amgen is likely to come in second in the race to launch new cholesterol treatments in the U.S., but the Big Biotech is leading the charge in Europe, securing a crucial regulatory recommendation that clears the way for approval.
Amgen says it got the positive data it was looking for from a Phase II study of AMG 334, one of several experimental migraine drugs that share the same target and are in the running to compete against an old generation of drugs on the market.
Amgen is none too eager for Novartis to roll out its newly FDA-approved biosimilar version of its blockbuster Neupogen, and for now, it's getting its way: A U.S. appeals court has blocked sales of the copycat while the companies resolve a patent dispute.
As payers continue to flex their drug-pricing muscles, it's more important for drugmakers to land on their good sides--especially as companies prepare to roll pricey treatments onto the market. And pharma execs are taking note.
FDA staffers had their doubts this week heading into an advisory committee meeting on Amgen's dual-acting cancer vaccine/viral therapy, talimogene laherparepvec (T-Vec). But Wednesday afternoon, a combined FDA advisory panel voted overwhelmingly in favor of the candidate.
Amgen's regulatory team for talimogene laherparepvec (T-Vec) was grilled by a group of outside FDA experts who picked up on some major questions regarding the Phase III melanoma study that was used to back its new drug application. A vigorous defense of the drug, though, helped make a winning case for the therapy, which was ultimately supported by all but one member of the panel.
Amgen took its best case for its dual cancer-killing oncolytic virus/cancer vaccine talimogene laherparepvec (T-Vec) to an FDA advisory committee this morning.
While Amgen has been busily chopping thousands of staffers throughout its organization while reducing its R&D budget, one of its goals in the restructuring--which was repeated in its 10Q earlier this week--was to beef up its presence in two key hubs: San Francisco and Cambridge, MA. And it's following through with a plan to add 100 staffers in the Boston-area hub this year.
FiercePharmaAsia combs earnings calls by major drug companies for notable and quotable nuggets on emerging markets and Asia to track the latest sales trends and insight into business outlooks in markets as diverse as China, India and Japan to Southeast Asia.