Health Canada Approves Glaukos’ Glaucoma Stent System August 10, 2015 The injectable stent reduces intraocular pressure. Read More
IBM to Acquire Merge Healthcare for $1 Billion August 7, 2015 IBM will combine Merge with its Watson Health Cloud. Read More
House Committee Questions FDA about NIH Shutdown August 7, 2015 An inspection of NIH’s Pharmaceutical Development Section found serious deviations from good manufacturing practices. Read More
InspireMD Teams Up with Penumbra to Market Embolic Protection Product August 6, 2015 The product has not been cleared by the FDA. Read More
Drugmakers Say FDA Draft Guidance Not Clear on Reporting Timeframe August 6, 2015 Companies want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to FDA. Read More
Boston Scientific Closes Endo International Deal August 5, 2015 Deal is worth $1.6 billion. Read More
Mallinckrodt Loses ADHD Drug Lawsuit Against FDA August 5, 2015 Court upholds FDA’s decision to revoke Mallinckrodt’s equivalence rating for its generic version of Janssen’s ADHD drug Concerta. Read More
Cook Medical Issues Recall of Beacon Tip Angiographic Catheter Products August 4, 2015 More than 95,000 devices subject to recall. Read More
Pfizer Stops OTC Lipitor Program in U.S. Following Trial Failure August 4, 2015 A Phase 3 clinical trial showed that patients required a physician’s help to take the drug correctly. Read More
Lombard Acquires Endovascular Graft Manufacturer Altura August 3, 2015 The deal is for $15 million in Lombard stock, and up to $27.5 million in milestone payments. Read More
FDA Warns Another Foreign API Maker for Data Integrity Issues August 3, 2015 The agency continues to crack down on API makers for poor data integrity. Read More
FDA Approves ReShape Medical Balloon for Weight Loss July 31, 2015 It is a first of its kind non-surgical weight loss procedure. Read More