The FDA accepted Novartis' application to sell a knockoff of Amgen's biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.
Amgen's in-development treatment for patients on kidney dialysis met its primary and secondary goals in a late-stage trial, step one in the drug's three-part Phase III program.
Best-selling drugs did well for themselves in 2013, churning out more than $76 billion in sales. But big-name brands could stand the test of time and help the top 10 rake in more than $80 billion in 2020, according to a new report.
Amgen nabbed a breakthrough designation for its mid-stage blood cancer drug blinatumomab.
Amgen has scored boasting rights to a breakthrough drug designation from the FDA for its promising mid-stage leukemia drug blinatumomab.
Many cancer doctors have cut back on their use of Amgen's anemia drug Epogen--also sold as Procrit by Johnson & Johnson--because of safety questions that arose over the past few years. But as The Wall Street Journal reports, one Florida doctors' group still administers the drug in quantity, accounting for one-sixth of related Medicare charges in 2012.
Amgen is hardly gun shy about high-risk, high-reward R&D bets, but the Big Biotech's swing-for-the-fences approach to research is bad for the bottom line, according to Bernstein analyst Geoffrey Porges.
Back in April, Amgen's cancer-fighting viral vaccine stumbled in Phase III, missing on overall survival, a secondary endpoint. But that won't stop the California company from seeking regulatory approval, it announced early this week.
Breaking up Big Pharma is all the rage these days. Jami Rubin at Morgan Stanley and Bernstein's Tim Anderson have kept a fire burning under Pfizer's board that has steadily built pressure on the company to break up. Abbott split off its drug arm and made AbbVie. And the recent major league trade between Novartis and GlaxoSmithKline relied on the same sort of financial dissection.
For an idea of what kind of year a drug developer had, take a look at what it paid its head of R&D. Click through our roundup for a look at who ranks where in the biopharma R&D world. Read more >>