Amgen's multiple myeloma treatment Kyprolis finally won approval in Europe--and with competition heating up across the pond, the go-ahead couldn't have come at a better time.
It's been more than three years since Amgen's multiple myeloma treatment Kyprolis won approval from U.S. regulators. Now, it's finally done the same in Europe--and with competition heating up across the pond, the go-ahead couldn't have come at a better time for the California biotech.
Amgen's PCSK9 med Repatha and Sanofi and Regeneron's competitor Praluent may have both nabbed coverage from top PBM Express Scripts. But now, Amgen has inked an exclusive pact with the giant's archrival, CVS.
In the jockeying for share in the brand-new market for the specialized PCSK9 cholesterol-lowering meds, Amgen has picked up an edge over Sanofi by nailing a formulary exclusive with CVS. To get that preferred spot, Amgen has again agreed to tie the price of the drug to its effectiveness.
Samsung Bioepis is months away from winning European clearance to market a copy of Amgen and Pfizer's blockbuster rheumatoid arthritis treatment Enbrel, securing a positive recommendation from EU regulators.
Amgen got a thumbs-down from U.K. cost watchdog the National Institute for Health and Care Excellence (NICE) for its PCSK9 cholesterol-fighter Repatha (evolocumab), bad news for the drug as it contends with pricing pushback and competes head-to-head with Sanofi and Regeneron's Praluent for market share.
Novartis is moving toward the U.S. market with a biosimilar of Amgen's Neulasta, awaiting FDA approval for a long-acting treatment designed to boost white blood cell count.
Dan Loeb, the activist investor who once called for Amgen to break itself in two, is now advising the Big Biotech to consider merging with Allergan, according to Bloomberg.
Amgen may have pulled off a pay-for-performance pricing deal on its pricey new cholesterol drug Repatha with Boston-based Harvard Pilgrim. But other outcomes-based pricing negotiations haven't been as successful, and there are major reasons why.
Amgen has been edging toward a Big Pharma qualification for some time--not only with annual revenues that last year surpassed Eli Lilly & Co. and Bristol-Myers Squibb, but with investor-friendly trappings like dividends, buybacks and billion-dollar cost cuts.