The FDA has handed AstraZeneca a green light to begin marketing dapagliflozin, its long-delayed SGLT2 diabetes drug, which will now try to defy the steadily dwindling expectations of market analysts. The treatment--the first new FDA drug approval for 2014--will be sold as Farxiga.
When Bristol-Myers Squibb got out of the diabetes development business a couple of months ago, the logical follow-up question was this: Will the company bag diabetes sales, too? The answer is yes.
As Bristol-Myers Squibb backs away from diabetes development, AstraZeneca has stepped up to buy its partner's stake in the pair's joint venture, agreeing to hand over as much as $4.1 billion in a move that will add some promise to a thinning pipeline.
AstraZeneca and Bristol-Myers Squibb look to be feeling good about the future of their diabetes drug Forxiga. The drugmakers have yanked the diabetes treatment from the market in Germany because they couldn't get the reimbursement they wanted from medical insurers. The nose-thumbing move came the day after an FDA panel recommended the drug for approval in the U.S.
Two years after a stinging rejection at the hands of the same committee, Bristol-Myers Squibb and AstraZeneca got a warmer reception for their diabetes drug dapagliflozin, winning a recommendation from an FDA advisory panel and brightening their odds of approval for the once-rebuffed therapy.
Bristol-Myers Squibb agreed to license its HIV fighter Reyataz (atazanavir) to the Medicines Patent Pool, which will allow generics makers to turn out cheaper copies for sale in poor countries.
Bristol-Myers Squibb's rare disease treatment metreleptin isn't up to snuff for its desired indication, an FDA committee voted, but agency advisers believe the drug shows some promise in a small subset of patients, giving the drug giant some hope for approval.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the treatment's dangers.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
Bristol-Myers Squibb will go into its Wednesday panel session for the lipodystrophy drug metreleptin with an agency review that offers a grudging concession on signs of efficacy for a subgroup of patients along with some serious questions about potential safety issues and a number of criticisms for the way the clinical trial program was designed and executed.