Amgen hit the trifecta with a successful conclusion to its third, and last, Phase III study of AMG416, a new drug for secondary hyperparathyroidism which handily beat out its in-house rival Sensipar in a head-to-head study.
Japan's Takeda Pharmaceutical opened an emerging markets and vaccines headquarters in the gleaming new research hub Biopolis on Feb. 25 in the wealthy city-state as it looks to bring a Phase III dengue candidate through trials successfully and challenge Sanofi's lead in the space.
The FDA accepted Apotex's application to copy an Amgen blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.
Three years after Takeda decided to double down on motesanib for non-small cell lung cancer, in-licensing full rights to the drug from Amgen following their big Phase III failure in 2011, the company has once again come up empty-handed in a major late-stage test of the therapy.
Amgen has high hopes for its new cancer vaccine, barreling toward global approvals with positive data in melanoma. But a narrow miss on one key endpoint could present a major hurdle, and Amgen will soon get a chance to defend the treatment before a panel of FDA advisers.
Novartis and its Neupogen biosimilar are steamrolling toward the U.S. market. But Amgen hasn't given up stopping the product in its tracks. The biotech last week urged a California court to block the biosimilar launch, with FDA approval expected as soon as March 9.
Amgen wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.
For the past couple of years, the pharma industry has had something of a reprieve from patent-cliff nightmares. But according to Moody's Investors Service, some companies face new threats to their sweet dreams.
After leapfrogging pharma stalwarts like Eli Lilly and Bristol-Myers Squibb with its 2014 revenue haul, Amgen is enjoying its new status as one of the industry's top-selling drugmakers. And it's hoping new regulatory filings for multiple myeloma drug Kyprolis can help it keep the sales leaps coming.
Amgen, a big R&D spender facing calls for a breakup, is headed for a major referendum on its strategy in 2015 as a slew of its pipeline assets come up for regulatory review or late-stage results.