Days after Onyx Pharmaceuticals' banner drug came through in a big Phase III trial, Amgen is laying off about 40% of the subsidiary's staff, shedding roughly 300 workers amid widespread cuts around the industry.
It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's Neupogen from Novartis' generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss pharma's CEO has been first to admit.
Novartis will be the first to hit U.S. shores with a copy of a blockbuster biotech drug, winning FDA approval for its take on Amgen's Neupogen and heralding a new era in biopharma.
Drug delivery is proving to be a useful and economical source of innovation due to the difficulty and cost of finding new molecular drug candidates, Forbes says in its article, "Is the future of pharma about making good drugs great?"
Amgen just announced the debut of the Neulasta Delivery Kit to automatically deliver the medication for infection prevention among cancer patients about 27 hours after chemotherapy, thereby ensuring compliance with the dosing instructions.
Interim results are in from Amgen's head-to-head trial between its blood cancer drug Kyprolis and Takeda's Velcade, and things are looking good for the California biotech. Twice as good as they are for Takeda, in fact, when it comes to progression-free survival.
A week after first raising the flag on their newborn biotech, a pair of entrepreneurs unhatched a deal today to take down a drug program that has been gathering dust on Amgen's R&D shelves for the past 7 years and test it as a new treatment for celiac disease.
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.