2017

FDA improves access to reports of adverse drug reactions

Friday, September 29, 2017

The FDA launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

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FDA selects participants for new digital health software precertification pilot program

Wednesday, September 27, 2017

The FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

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Allianz Teams, Cyence partner on cyber risk modeling and analysis

Wednesday, September 27, 2017

Allianz Global Corporate & Specialty SE (AGCS), Allianz Group’s specialist carrier for corporate insurance business, has teamed up with Silicon Valley-based cyber risk analytics and modeling firm Cyence to boost its global cyber risk analysis capabilities. By combining Cyence’s cyber analytics platform with AGCS’ underwriting processes, the insurer will be able to analyze cyber exposures at company level for large businesses, creating a detailed understanding of their cyber risks and quickly allowing it to tailor coverage to fit specific customer profiles.

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Rubius Therapeutics appoints Chief Medical Officer Chris Carpenter

Wednesday, September 27, 2017

Rubius Therapeutics, a “Fierce 15” company pioneering the creation of a new class of extraordinarily active, ready-to-use and life-changing cellular therapies, announced the appointment of Chris Carpenter, M.D., Ph.D., as chief medical officer. Dr. Carpenter will oversee Rubius’ clinical and regulatory strategy as the company prepares to enter human clinical trials in 2018. In addition, Rubius announced the appointments of Joanne Protano as vice president of finance; Mark Boshar as vice president of legal affairs; and Theo Proukou as vice president of human resources.

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Sound Pharmaceuticals initiates STOP Ototoxicity study in cystic fibrosis

Wednesday, September 27, 2017

Sound Pharmaceuticals (SPI) has initiated enrollment on its first study involving Cystic Fibrosis (CF) patients receiving antibiotics that cause inner ear disease or ototoxicity. The STOP Ototoxicity study is led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston. Dr. Flume is an international expert in CF and pulmonary disease and has co-chaired the development of the CF Foundation’s care guidelines on the treatment of pulmonary exacerbations. “We recently explored the incidence of tinnitus and vertigo in the CF population, and will present these initial findings at the next North American CF Conference,” said Dr. Flume.

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W. L. Gore & Associates completes enrollment in GORE CARDIOFORM study

Wednesday, September 27, 2017

W. L. Gore & Associates has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The GORE® CARDIOFORM ASD Occluder is designed with a unique, anatomically adaptable waist to accommodate the natural anatomy of the heart and mitigate the potential for cardiac injury. This new device will complement the existing GORE® CARDIOFORM Septal Occluder to allow the treatment of a broader range of ASDs with a soft, conformable device design.

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