FDA Accepts Intercept’s NDA for OCA for the Treatment of Liver Fibrosis Due to NASH and Grants Priority Review

Posted in Biotech by Medtech[y] Staff

November 25, 2019 • 2 min read

​Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted Intercept’s New Drug Application (NDA)...

Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for FINTEPLA for the Treatment of Dravet Syndrome

Posted in Biotech by Medtech[y] Staff

November 25, 2019 • 2 min read

​Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for FINTEPLA (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet syndrome...

VBI Vaccines Presents Early GBM Tumor Response and Immunologic Data from Part B of Ongoing Phase 1/2a Study of VBI-1901 at the 2019 SNO Annual Meeting

Posted in Biotech by Medtech[y] Staff

November 22, 2019 • 2 min read

​VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the presentation of interim data from Part B of the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate,...

Favorable Outcomes with TCAR vs. Carotid Endarterectomy in Patients with Carotid Artery Disease

Posted in Medical Device by Medtech[y] Staff

November 22, 2019 • 2 min read

​Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the VEITHsymposium. In a headline presentation, Dr. Mahmoud Malas of the University of California...