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...

Senseonics Publishes Positive Longitudinal Performance Over Multiple Sensor Insertions and Removal Cycles of the Eversense CGM System

Posted in Biotech by Medtech[y] Staff

November 21, 2019 • 2 min read

​Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced the publication of an assessment of the performance of multiple sequential cycles of Eversense 90 and 180-day CGM System...

Merit Medical Receives FDA Breakthrough Device Designation for WRAPSODY Endovascular Stent Graft System

Posted in Medical Device by Medtech[y] Staff

November 21, 2019 • 2 min read

​Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the Merit WRAPSODY Endovascular Stent Graft System....

Biogen Announces Enrollment Completion of Global Phase 3 Gene Therapy Study for an Inherited Retinal Disorder

Posted in Biotech by Medtech[y] Staff

November 21, 2019 • 2 min read

Biogen Inc. (Nasdaq: BIIB) announced today the enrollment of the last patient in the global Phase 3 STAR clinical study, which is evaluating the investigational gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM). CHM is a rare, degenerative, X-linked inherited retinal disorder that leads to blindness....

Trevena Announces Publication of Results from Phase 3 “Real World” Safety Study for Oliceridine in The Journal of Pain Research

Posted in Biotech by Medtech[y] Staff

November 20, 2019 • 2 min read

​Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced publication of results from the Phase 3 open-label safety study (ATHENA) for IV oliceridine in The Journal of Pain Research....