Myovant Sciences Announces 97% Response Rate in Positive Phase 3 HERO Study of Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

Posted in Biotech by Medtech[y] Staff

November 19, 2019 • 2 min read

​Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women's health and prostate cancer, today announced that the Phase 3 HERO study of once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer. These results support a New Drug Application (NDA)...

Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure

Posted in Biotech by Medtech[y] Staff

November 19, 2019 • 2 min read

​Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 VICTORIA study evaluating the efficacy and safety of vericiguat, a soluble guanylate cyclase (sGC) stimulator being developed to treat patients with worsening chronic heart failure, has met the primary efficacy endpoint. Vericiguat reduced the risk...

Axonics Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Posted in Medical Device by Medtech[y] Staff

November 15, 2019 • 2 min read

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM System...

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT Outcomes Trial

Posted in Biotech by Medtech[y] Staff

November 14, 2019 • 2 min read

​Amarin Corporation plc (NASDAQ: AMRN) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa (icosapent ethyl)...