Report Finds QMS Lapses, AE Reporting as Top Major Deviations During EU Postmarketing Inspections August 18, 2015 Eighteen facilities were cited for QMS issues and 13 for problems with AE reporting. Read More
FDA Clears GE Healthcare for Low Dose CT Lung Cancer Screening Option August 17, 2015 GE Healthcare first to receive FDA clearance for low dose CT lung cancer screening option. Read More
Drugmakers Seek More Flexibility from FDA in Developing DMD Drugs August 17, 2015 Companies say the June draft guidance doesn’t go far enough. Read More
Integra LifeSciences Completes Purchase of TEI Businesses August 14, 2015 The deal expands Integra’s reconstructive surgery and wound care product lines. Read More
Lilly Wins Cymbalta Lawsuit, Begins New Trial August 14, 2015 A jury said the drugmaker wasn’t liable for the plaintiff’s severe withdrawal symptoms. Read More
NOWDiagnostics Gets 510(k) Approval for Blood Pregnancy Test August 13, 2015 Test can diagnose pregnancies two to eight days earlier than urine-based tests. Read More
DOJ Subpoenas Allergan Over Generic Pricing August 13, 2015 The probe is part of a larger investigation into rising generic prices. Read More
DexCom, Google Team Up on Next-Generation Continuous Glucose Monitors August 12, 2015 The goal is smaller, less-expensive devices for diabetics. Read More
India Abandons Trade Talks to Protest EU Drugs Ban August 12, 2015 The EU banned generic drugs tested by GVK Biosciences. Read More
Terumo BCT Gets FDA Approval for Longer Platelet Storage August 11, 2015 It extends the storage of platelets in plasma from five days to seven. Read More
European Commission Approves Pfizer-Hospira Merger August 11, 2015 Approval is contingent upon the divestiture of certain drugs. Read More
Appeals Court Denies Bid to Block Mylan’s Generic Nexium August 10, 2015 The decision paves the way for additional competition for the acid reflux drug. Read More