Two Cancer Drugs from Astellas, BMS Win NICE Recommendations July 28, 2014 Astellas Pharma’s prostate cancer drug Xtandi and Bristol-Myers Squibb’s melanoma treatment Yervoy approved for coverage. Read More
CE Mark Awarded to Sorin Group’s Crown PRT Heart Valve July 25, 2014 The system uses intraoperative MRI technology to deliver better images and increase productivity. Read More
Irish Regulators Recommend 34 Drugs for OTC Use July 25, 2014 HPRA issued a list of 12 active ingredients in the drugs, which can be reclassified. Read More
IMRIS’ Visius Surgical Theatre Wins CE Mark July 24, 2014 The system uses iMRI technology to deliver better images and increase productivity. Read More
Acorda Fighting Six Generic Challenges to Ampyra July 24, 2014 Most of the ANDA filers are challenging all five of Ampyra’s patents. Read More
Teleflex Cleared to Market Arrow-Clark VectorFlow Catheter July 23, 2014 The chronic hemodialysis catheter allows for easier placement and minimal recirculation. Read More
Concordia Chided by FDA Over Its ADHD Drug’s Misleading Sales Pitch July 23, 2014 Agency says telephone sales pitch omits critical risk and dosing information. Read More
Veniti Gets Green Light for Clinical Trials of Vein-Specific Stent July 22, 2014 U.S. trials of the Veniti Vici Venous Stent System are slated to begin this fall. Read More
FDA Pulls Remaining ANDAs of High-Dose Acetaminophen Products July 22, 2014 ANDAs were from firms that failed to submit sufficient data with withdrawal applications or didn't submit an application at all. Read More
FDA Clears Varian Medical System’s Calypso Soft Tissue Beacon Transponder July 21, 2014 The device allows high-energy cancer treatment beams to be aimed precisely, reducing exposure to healthy tissue. Read More
FDA Approves Salix Pharmaceuticals’ Relistor sNDA for New Indication July 21, 2014 Drug is approved for treatment of OIC in patients taking opioids for non-cancer pain. Read More
Terumo BCT Completes Construction of Vietnam Plant July 18, 2014 The new $100 million manufacturing facility will begin operations in 2015. Read More