Stryker Initiates Global Recall of Select Target Nano Neuro-coils June 30, 2016 The recall was prompted by issues with substandard stretch resistance. Read More
FDA Pushes Back Comment Period on Hep C Drug Development Guidance June 30, 2016 The agency has extended the comment period to July 19. Read More
Analogic Ends Foreign Bribery Charges Against Distributor June 29, 2016 Analogic agreed to pay nearly $15 million. Read More
House Democrats Unveil Bill to Cut Exclusivity for Innovator Biologics June 29, 2016 The bill was sponsored by Rep. Janice Schakowsky. Read More
CorMatrix Earns CE Mark Approval for CanGaroo June 28, 2016 The device nabbed FDA clearance in August 2014. Read More
Court Rejects Mylan’s Rehearing Request in Two Patent Suits June 28, 2016 The court’s decision leaves the company with few options for avoiding the cases. Read More
Draft Guidance Spells Out Strategy to Increase Diversity in Clinical Trials June 27, 2016 The agency outlines what demographic variables should be considered in study designs. Read More
Arizona, New Jersey Compounders Earn Warning Letters Over Sterility June 27, 2016 A Wyckoff compounder was cited for distributing adulterated and misbranded products. Read More
Oxford Immunotec to Acquire Imugen June 24, 2016 The transaction is expected to close next month. Read More
NICE Recommends BMS’s Melanoma Combination Treatment June 24, 2016 The agency recommended the Opdivo and Yervoy combo. Read More
St. Jude Earns CE Mark Approval for SyncAV June 23, 2016 The software is intended to work in conjunction with the company’s MultiPoint Pacing technology. Read More
Health Plans Aim To Connect Costs of Hep C, Cancer Drugs to Patient Outcomes June 23, 2016 Most health plans seek outcomes-based contracts with specialty drugmakers. Read More