Amgen is jumping back into the M&A game. And it's looking for another Onyx-sized deal that can deliver a late-stage drug ready to be hustled across the finish line.
Amgen is taking its brand-new cholesterol drug into uncharted territory. The drugmaker has negotiated a pay-for-performance deal with the health plan Harvard Pilgrim, gaining an exclusive spot on the payer's formulary in return for an upfront discount and future rebates if Repatha doesn't perform as outlined.
Amgen's Imlygic became the first genetically modified oncolytic viral therapy to earn FDA approval.
Amgen is steeling itself against biosimilar competition to some of its top meds, with a biosimilar of its best-selling cancer drug Neupogen hitting the market in September and threatening to take a bite out of sales. But the company hasn't hit the eye of the storm just yet, as older products delivered Street-beating sales in the third quarter and new drugs showed potential in helping Amgen shore up its defenses.
In the last week, Amgen received regulatory endorsements on each side of the Atlantic for its first-in-class oncolytic viral therapy talimogene laherparepvec, known as T-Vec.
Amgen won a landmark approval for a re-engineered virus designed to fight skin cancer, preparing to launch a first-of-its-kind therapy that could star in future combination treatments.
Amgen is now months away from a likely European approval with a first-of-its-kind cancer therapy, securing a positive opinion from a key regulatory group.
At Express Scripts, both Sanofi and Regeneron's Praluent and Amgen's Repatha scored a spot on the preferred formulary, which gives both PCSK9 products a chance to snare the pharmacy benefits manager's patients.
The media blitz over jacked-up drug prices and concerns over slowing growth in China may have temporarily kicked the breath out of pharma valuations, but some analysts think the concerns will be short-lived and a return to growth is inevitable.
Right now, Novartis' Sandoz has the only biosimilar on the U.S. market. And it's looking to make it two.