Riding momentum from an FDA advisory committee recommendation last month, Amgen rolled out its data from a pivotal study of its cancer vaccine talimogene laherparepvec (T-Vec) on Tuesday as it awaits the agency's final decision, expected later this year.
Payers have promised a fight over the price of PCSK9 drugs, a new class of cholesterol fighters expected to be a pricey proposition.
Payers have promised a fight over the price of PCSK9 drugs, a new class of cholesterol fighters. Drugmakers in the field--including frontrunners Amgen and Sanofi--prepared for that fight. And now, analysts think they've defined the battle lines.
The crowded next-gen psoriasis landscape may lose a contender, now that Amgen has bailed out of its brodalumab pact with AstraZeneca. And if the British pharma decides to go it alone, it'll face plenty of contenders--not to mention reports of side effects--that could make building market share an uphill battle.
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 shoo-in at the FDA. But late Friday evening, 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.