The U.S. FDA approved Senseonics Holdings’ Premarket Approval application to market the company’s Eversense Continuous Glucose Monitoring System to people with diabetes.
What are key trends in the transparency compliance landscape? And, how are life sciences manufacturers tackling growing requirements
The U.S. FDA approved for marketing DreaMed Diabetes’ Advisor Pro software to help manage diabetes treatment.
DyAnsys Inc. announced that the U.S. Food and Drug Administration cleared the company’s auricular neurostimulation device, Drug Relief, to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics.
Five Prime Therapeutics Announces Collaboration with Roche to Develop Companion Diagnostics for Targeted Immuno-Oncology Investigational Drug Candidates
Five Prime Therapeutics announced a collaboration with Roche to develop immunohistochemistry companion diagnostic assays for use with the clinical-stage biotechnology company’s first-in-class investigational drug candidates: the anti-FGFR2b antibody bemarituzumab (also known as FPA144) and the a B7-H4 antibody FPA150.
GSK Submits Regulatory Application in Japan for Once-Daily Single Inhaler Triple Therapy FF/UMEC/VI for Patients with COPD
GlaxoSmithKline plc and Innoviva Inc. announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease. This is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.
Foundation Medicine Inc. announced a collaboration with Merck & Co. to develop companion diagnostic tests for use with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability high or mismatch repair deficient solid tumors.
Abbott received approval from the U.S. Food and Drug Administration for XIENCE Sierra, the newest generation of the gold-standard XIENCE everolimus-eluting coronary stent system.
U.S. regulators said Mylan NV’s EpiPen products are in shortage, due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment.
India has told the United States it will not abstain from capping prices for more medical devices, regardless of pressure to rethink its stance after price controls on heart stents and knee implants spoilt the market for some U.S. firms, sources familiar with the matter said.
J&J secured a favorable U.S. appellate court ruling, overturning a verdict that awarded $151 million to five people who blamed injuries they suffered on the company’s Pinnacle hip implant devices.
Oxygen supply device maker Inogen Inc. said the company was notifying 30,000 existing and former customers following a data breach that led to improper access of personal details of some rental clients.
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
The U.S. Food and Drug Administration permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.
Philips and Hologic announce global partnership agreement to provide integrated imaging solutions for women’s health
Royal Philips, a global leader in health technology, and Hologic Inc., an innovative women’s health company, announced today a global partnership agreement to offer care professionals integrated solutions comprising diagnostic imaging modalities, advanced informatics and services for screening, diagnosis and treatment of women across the world.
Fast Company recently published The World’s 50 Most Innovative Companies 2018, topping off its edition of the top 350 most innovative companies. Here is a look at the life science companies that made the list.
Heart devices that use software or wireless communications may be vulnerable to hacker attacks that could cause life-threatening malfunctions, U.S. cardiologists say.
W2O announced the appointment of Rita Glaze as Practice Leader of Value, Pricing and Market Access to strengthen its healthcare commercialization offering.
AstraZeneca said an inhaler for chronic obstructive pulmonary disease (COPD) delivered improved lung function in a late-stage trial that could challenge GlaxoSmithKline’s new three-in-one inhaler.
ProMIS Neurosciences Inc., a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, announced it has issued a new scientific white paper entitled: ‘Not all Amyloid Beta Therapeutics are Created Equal’.
Amgen’s migraine drug Aimovig continues to impress with its efficacy in late-stage clinical trials.
A sound-emitting device worn in the ear during sleep may train the brain to ignore an annoying chronic ringing in the ears, a new study suggests.