BioSpace News Archive

Regeneron Pharmaceuticals, Inc. announced that an ongoing Phase 2 proof-of-concept trial evaluating an investigational 8 mg dose of aflibercept met its primary safety endpoint, with no new safety signals observed compared to the currently-approved 2 mg dose of EYLEA® Injection in patients with wet age-related macular degeneration.

Castle Biosciences, Inc. today announced that it has been awarded a five-year U.S. Federal Supply Schedule (FSS) contract from the Veterans Health Administration (VHA) for its DecisionDx®-Melanoma gene expression profile test.

Cassava Sciences, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for both of its pivotal Phase 3 studies of oral simufilam for the treatment of patients with Alzheimer’s disease.

Oramed Pharmaceuticals Inc. announced today that it has enrolled and randomized over 25% of the planned 450 patients for its Phase 3 ORA-D-013-2 trial of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D).

HMNC Brain Health (“HMNC” or the “company”), a clinical stage biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, will advance the development of an investigational oral prolonged- release formulation of ketamine targeting treatment-resistant depression (TRD) with a clinical phase-II-study that will commence in Q4 2021.

South Korean artificial intelligence (AI) developer, VUNO Inc. announced today that it has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) for its VUNO Med®–DeepCARS™, an AI medical device for cardiac arrest prediction through vital signs.