Drug R&D is a tough business. The odds are almost always against success, and the price to be paid for being wrong is cruelly high. That said, it did seem a little harder than usual this year to...
A recent FDA panel vote over AstraZeneca's gout candidate may have gone the drugmaker's way, but safety concerns and a dearth of clear-benefit evidence may trip it up in the market if regulators ultimately give it a green light.
A majority of independent FDA advisers recommended approval for AstraZeneca's new gout drug, but not without noting that the treatment's safety profile presents considerable concerns going forward.
AstraZeneca and Eli Lilly are taking their immuno-oncology collaboration a few big steps forward, with Lilly lining up a new series of combination studies matching its cancer therapies with AstraZeneca's big PD-L1 program for durvalumab (MEDI4736).
AstraZeneca has laid out a host of new manufacturing projects in recent months, including new biologics plants in Europe and the U.S. But while those projects are in the works, it has a new tablet plant in Russia that has just gone online.
AstraZeneca's new gout therapy, acquired in a $1.3 billion buyout, might not be effective enough to outweigh its safety risks, according to FDA staff, casting doubts on the drug's future as it heads for a key panel vote.
AstraZeneca now has a new production facility in Russia to draw on, although that market is less vibrant than it was four years ago when the project was launched.
Emerging markets have been a beacon for AstraZeneca CEO Pascal Soriot as he pilots the U.K. drugmaker through its challenges. And he now has a new production facility in Russia to draw on, although that market is less vibrant than it was four years ago when the project was launched.
Last year, AstraZeneca predicted its forthcoming diabetes combo med could generate peak annual sales of $3 billion. But those revenues will have to wait. The FDA has turned down the drug, which combines AZ's DPP-4 therapy, Onglyza, with SGLT2 contender Farxiga.
The FDA wants to see more clinical trial data on AstraZeneca's new combination diabetes treatment, the company said, likely delaying a potential launch by more than a year.