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.
AstraZeneca and Bristol-Myers grabbed a win in the EU today for one of the drugs sprung from their diabetes treatment partnership. But the recommended approval comes even as questions have bubbled up about the future of that relationship.
Last week, Bristol-Myers Squibb said it would jettison some research programs, lay off workers and generally reorganize R&D. Now, CEO Lamberto Andreotti is rejigging the commercial side of the business. In the shuffle, current commercial chief Beatrice Cazala will be shunted aside, with current U.S. President Giovanni Caforio taking her place.
When Bristol-Myers Squibb reported earnings last week, it seemed fully committed to AstraZeneca and their multibillion-dollar diabetes joint venture. Sales growth there helped make up for hundreds of millions lost to generic competition. But now, Bristol-Myers says it's getting out of the diabetes discovery business. Will the company back away from its diabetes partnership next?
Bristol-Myers Squibb joined the lineup of biopharma companies executing R&D realignments today, announcing plans to cut back on some of its discovery work in three key disease areas and eliminate 70 to 75 positions in its R&D group as it concentrates resources on late-stage programs.
In a notable first, Bristol-Myers Squibb has filed a combination of daclatasvir and asunaprevir for approval to treat hepatitis C in Japan--the first all-oral combo in a regulatory package that excludes interferon.
Bristol-Myers Squibb's little-discussed rheumatoid arthritis drug clazakizumab posted strong results in a mid-stage study, meeting its endpoints, notching promising remission data and stirring hopes that the treatment can compete with AbbVie's blockbuster Humira.
Bristol-Myers Squibb has added a few more brushstrokes to the very promising picture that's emerging from early-stage studies of nivolumab, a top PD-1 checkpoint receptor inhibitor billed as a major breakthrough in cancer drug research.