When Amgen rolled out its Blincyto treatment for an ultra-rare form of leukemia, the California biotech set what seemed to be an eye-watering price--$178,000 for a typical patient. But some number-crunching of clinical trial data, coupled with documents from the Centers for Medicare and Medicaid Services, suggests that the real-world cost will be much lower.
Amgen's investigational bone-growing drug met its main goal in a late-stage trial, clearing its first Phase III hurdle by besting an Eli Lilly blockbuster for osteoporosis.
Amgen is buying into Novartis' early-stage BACE program for Alzheimer's, paying an unspecified upfront and milestones in exchange for a cut of the program, which looks to slash the production of a key toxic protein widely viewed as a prime suspect in the development of the memory-wasting ailment.
Three months after Amgen washed its hands of the psoriasis drug brodalumab, its development partner AstraZeneca has found the exit door as well. The pharma giant auctioned off the Phase III-complete therapy to the wheeler dealers at Valeant in exchange for $100 million upfront, $170 million in prelaunch milestones and another $175 million in sales bonuses.
Last Thursday's FDA approval for Amgen's PCSK9 competitor, Repatha, kicked off a head-to-head contest between that med and recently green-lighted Praluent from Sanofi and Regeneron. And with the newcomers bearing similar labels, both Sanofi and Amgen are counting on their legacies to give them a leg up in the marketplace.
Amgen scored the big win for its PCSK9 drug Repatha (evolocumab). The FDA announced Thursday afternoon that it has given Amgen a green light on marketing the PCSK9 cholesterol drug, opening the door to what will likely prove a blockbuster market.
Amgen is likely to start today off with a case of bubbly chilling in the company cafeteria. The FDA has reached its deadline on a marketing decision for the cholesterol drug Repatha (evolocumab), which most likely is on the verge of becoming a major rival to the newly approved Praluent (alirocumab), from Regeneron and Sanofi.
Amgen is paying up to resolve claims that it broke the rules while marketing anemia drug Aranesp and anti-inflammatory blockbuster Enbrel. The company has settled with 48 states for $71 million, marking the latest state-level crackdown on alleged marketing violations in the pharma industry.
Amgen has already paid $762 million to wrap up off-label marketing claims with the feds. Now, 48 states have won another promise to pay from the California-based drugmaker. This time, it's $71 million to resolve allegations that it broke the rules when marketing its anemia drug Aranesp and anti-inflammatory blockbuster Enbrel, two of its best-selling meds.
It isn't too often that drugmakers and journalists go head-to-head in court. But as part of Amgen's latest legal battle, it's asking a federal judge to force a reporter to testify about an article he wrote that prompted a shareholder suit against the company and to spell out how he got information about an abandoned clinical trial.