According to new research published online Monday at the Journal of Clinical Oncology, 63% of the patients taking the immunotherapy were alive after one year and 43% were still alive after two years on the drug. And the researchers say that the durable response was also reflected in patients who had stopped taking the drug.
Bristol-Myers Squibb has picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's pioneering approach.
The National Institutes of Health has persuaded 10 rival drugmakers to briefly set aside their competitive spirits and collaborate on drug discovery projects in four major diseases, pooling their data and expertise to kick-start early-stage efforts.
Bristol-Myers Squibb says it's on the lookout for new deals, but that its focus will be on snapping up experimental treatments still in development instead of commercial products already on the market, according to a Bloomberg story.
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.
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.
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'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 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.