Medical Tidbits,FDA Grants Priority Review for Amgen’s Supplemental New Drug Application for Expanded Labeling of Kyprolis® (Carfilzomib) in Relapsed Multiple Myeloma

pharmaceutical clinical trials

THOUSAND OAKS, Calif., Sept. 18, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for patients with relapsed multiple myeloma. The sNDA is designed to expand the current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy. The Prescription Drug User Fee Act (PDUFA) target action date is Jan. 22, 2016 read more

Pivotal Phase 3 Studies of Bezlotoxumab, Merck’s Investigational Antitoxin to Prevent Clostridium Difficile Infection Recurrence, Met Primary Endpoint

KENILWORTH, N.J.–(EON: Enhanced Online News)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for the treatment of C. difficile. Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the U.S., EU and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile. read more

Boehringer Ingelheim and BioMed X apply crowdsourcing to establish a team of scientists for identifying key epigenetic regulators of COPD

INGELHEIM & HEIDELBERG, Germany–(EON: Enhanced Online News)–Boehringer Ingelheim and BioMed X announced today that they have successfully applied a crowdsourcing approach to establish a research team of outstanding scientists from around the world with bright ideas, who will endeavor to identify new approaches for the treatment of patients with chronic obstructive pulmonary disease (COPD). read more

Aerie Pharmaceuticals Initiates First Phase 3 Registration Trial of Roclatan

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced that on September 18, dosing commenced of the first patients enrolled in Mercury 1, the Company’s first Phase 3 registration trial of RoclatanTM read more

Nextera AS Announces Research Collaboration with Johnson & Johnson Innovation

OSLO, Norway–(BUSINESS WIRE)–Nextera, a Norwegian biotechnology company focused on developing novel and highly disease-specific immunotherapies for autoimmune diseases, cancer and chronic infections announces today that it has entered into a research agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Johnson & Johnson Innovation Centre in London facilitated the research agreement. read more

EISAI SELECTED FOR THIRD CONSECUTIVE YEAR OF MEMBERSHIP OF DOW JONES SUSTAINABILITY ASIA PACIFIC INDEX 2015

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been selected for a third consecutive year of membership in the Dow Jones Sustainability Asia Pacific Index (DJSI Asia Pacific), the Asia Pacific version of the Dow Jones Sustainability Indices (DJSI), which are a family of premier global indices for socially responsible investment (SRI).

Early Patient Cases with Mitra-Spacer™ System presented at PCR London Valves 2015  

BERLIN and BOSTON, Sept. 21, 2015 /PRNewswire/ — Cardiosolutions, Inc., a development stage company possessing a novel, atraumatic, volume adjustable, mitral valve therapeutic device, unveiled its first-in-human experience with the Mitra-Spacer™ System. The technological achievement was presented at PCR London Valves in Berlin, Germany. The proprietary Mitra-Spacer System is intended to treat or bridge heart failure patients whose operative mortality risk for undergoing conventional open-heart surgery is deemed too high. read more

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