Boston Scientific Corp. forked over up to $160 million to acquire California stent maker Veniti Inc. The deal marks the third acquisition for Boston Scientific in two months.
What are key trends in the transparency compliance landscape? And, how are life sciences manufacturers tackling growing requirements
The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.
Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety.
After multiple suspensions, the U.S. House of Representatives overwhelmingly voted to repeal a 2.3 percent tax on medical devices which is part of the Affordable Care Act that industry representatives believes has stifled innovation.
Bayer will discontinue the sale of the healthcare company’s birth control product Essure in the United States.
The U.S. Food and Drug Administration granted Roche an accelerated review for the Swiss drugmaker’s Elecsys product used to diagnose Alzheimer’s disease.
AngioDynamics Inc. agreed to pay the U.S. government $12.5 million to resolve allegations that the company caused healthcare providers to submit false claims to federal healthcare programs over the use of two medical devices, the Justice Department said.
Abbott Laboratories raised its 2018 full-year earnings forecast and reported a quarterly profit that beat analysts’ estimates, powered by higher sales across its businesses.
Google’s Verily will team up with ResMed, a company that specializes in treating sleep disorders, to launch a joint business venture to address sleep apnea and other sleeping disorders.
The U.S. FDA approved Senseonics Holdings’ Premarket Approval application to market the company’s Eversense Continuous Glucose Monitoring System to people with diabetes.
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.