Amgen shocked the industry in May when it cut ties with an AstraZeneca-partnered psoriasis treatment after spotting alarming rates of suicidal thoughts among patients taking the antibody. But its former collaborator is remaining optimistic about the once-promising treatment, tentatively moving toward an FDA filing.
Amgen is giving Neulasta its first TV advertising push in years--just months before its patent expires. But there's a case to be made for promoting the biologic this late in the game.
Amgen, which has been looking to steal market share from Celgene's Pomalyst in treating multiple myeloma, has won a new FDA approval for Kyprolis that will help it in that fight.
Novartis' Sandoz may have the first FDA-approved biosimilar in Zarxio, but it doesn't have permission to launch--and it won't be getting that until September, the country's top patent court ruled Tuesday.
Amgen's new cholesterol fighter may be second in line for FDA approval in the U.S. But in Europe, it's officially first. Amgen's PCSK9 contender Repatha slipped past Sanofi and Regeneron's Praluent to win E.U. approval Tuesday, with a broad label that could help it build sales quickly.
A cadre of drugmakers is pressing toward late-stage trials with new injectable treatments in the long-stagnant field of migraine therapy, racing to capitalize on what analysts say is a multibillion-dollar market.
Amgen's manufacturing and R&D sites in Colorado are officially on the block and the company is hoping another drugmaker will be interested in buying them.
Amgen may be running a beat or two behind Regeneron and Sanofi in search of the first FDA approval for a PCSK9 drug, but the Big Biotech scooped up the very first approval in Europe today for Repatha (evolocumab), giving the company boasting rights as first mover in what is widely seen as a new blockbuster market in the making.
Amgen's working to expand the label of cancer-fighter Blincyto, and on that front, it's got some solid new data to help it make its case.
Amgen's new immuno-oncology treatment demonstrated promising efficacy in a midstage trial on a rare blood cancer.