FDA Enforcement of Off-Label Promotion Hindered by Website, Lawsuit September 14, 2015 A law professor says Amarin’s successful lawsuit against the FDA and ClinicalTrials.gov make enforcement more difficult. Read More
Boston Scientific Receives CE Mark for Deep Brain Stimulation System September 11, 2015 The system provides precise neural targeting for patients with Parkinson’s disease, primary and secondary dystonia and essential tremor. Read More
GSK Recalls More Than 427k Tubes of Antibiotic Creams and Ointments September 11, 2015 The recall is due to penicillin cross-contamination and the presence of particulates. Read More
Solta Launches Permanent Hair Reduction Laser September 10, 2015 The system uses a novel linear scanning approach with integrated contact cooling. Read More
FDA Approves Merck’s Anti-Nausea and Vomiting Drug for Children September 10, 2015 The drug is the first and only NK1 receptor antagonist approved for this indication in the U.S. Read More
RockTape Introduces Kinesiology Tape With Gentle Adhesive September 9, 2015 The tape is ideal for children, the elderly and others with sensitive skin. Read More
Allergan’s Phase 3 Studies of UTI Drug Support FDA Priority Review September 9, 2015 Allergan plans to file an sNDA for Avycaz by the end of the year. Read More
EMA’s Medical Literature Monitoring Service Kicks into Full Operation September 8, 2015 Drugmakers can easily search for information on adverse reactions associated with their products. Read More
Blue Belt Technologies Announces Support for ZUK Unicompartmental Knee September 8, 2015 The addition will provide ZUK users with a robotics-assisted option that does not require a compromise on implant preference. Read More
FDA Clears Teleflex’s ARROW Triple Hemodialysis Catheter September 4, 2015 The catheter provides maximal barrier protection against infections. Read More
Sandoz Urges Federal Circuit to Dismiss Amgen’s Effort to Block Neupogen Biosimilar September 4, 2015 Sandoz says Amgen’s emergency injunction doesn’t meet the required standard. Read More
Valeant to Acquire Synergetics USA September 3, 2015 The deal is worth $6.50 per share, and an additional $1 per share if specified sales milestones are achieved following the closing. Read More