BioSpace News Archive

The trial, B7451012, evaluated abrocitinib as a monotherapy for 12 weeks. The top-line data indicated that by week 12 the proportion of patients who hit each co-primary efficacy endpoint and each key secondary endpoint with either dose, 100 mg or 200 mg, were statistically significantly higher than placebo.

The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.

“ALS is a disease you really want to make a difference in,” Toby Ferguson Biogen’s senior medical director for Neuromuscular Research and Early Development told BioSpace.

Today, Civica Rx announced it had inked a product supply agreement with Xellia Pharmaceuticals, where Xellia will manufacture essential antibiotics, including Vancomycin and Daptomycin, for Civica’s members.

The FDA told the company that the results from the trial didn’t meet its primary endpoint under the pre-specified statistical analysis plan and the data around the secondary endpoints couldn’t be used to support an accelerated approval application.

The 96-Week data showed continued efficacy of GS010 two years after injection, with best-corrected visual acuity (BCVA) holding a clinically meaningful improvement over baseline.

Promore Pharma AB (publ) publishes its Interim report for the first quarter 2019 at 13.00 CET on 21 May 2019.

Auris Medical Holding Ltd. announced today the closing of its previously announced underwritten public offering

Pharma and biotech companies from across the globe provide business and pipeline updates, with news from Gecko, ValGenesis, NeuClone, Zymeworks, and more.

GeoVax Labs, Inc. announced that it will deliver a presentation showcasing the Company’s unique technology during the Innovative Vaccines Against Resistant Infectious Diseases and Emerging Threats Conference, presented by the Microbiology and Infectious Diseases Discussion Group of The New York Academy of Sciences.