BioSpace News Archive

MyoKardia, Inc., presented data at the European Society of Cardiology Heart Failure Congress from its Phase 1a single-ascending dose study of MYK-491 in healthy volunteers.

“Reaching this pre-specified clinical endpoint is an important milestone that brings us one step closer to a potential regulatory submission in both the U.S. and Europe for valoctocogene roxaparvovec to treat adults with severe hemophilia A,” stated Hank Fuchs, president of Worldwide Research and Development at BioMarin.

The approval of Jakafi marks the first approved treatment for this indication in the United States.

The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.

The patients receiving Lyrica didn’t show a statistically significant reduction in seizure frequency compared to placebo.

The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.

Eli Lilly announced it has inked a license agreement with Centrexion Therapeutics to acquire the exclusive global rights to CNTX-0290.

There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels.

Soligenix, Inc. announced that Soligenix will be participating in a biodefense contract for the development of medical countermeasures against bacterial threat agents, with Soligenix awarded a subcontract of approximately $600,000 over 3 years.

In a whitepaper released, CENTOGENE provided an update on its induced pluripotent stem cells program.