Otsuka Sues FDA Over Loss of Abilify Patent Protection October 26, 2015 Otsuka argues the FDA denied the brandmaker’s right to three years of exclusivity. Read More
Devon Medical Products Launches Cirona 6300 October 23, 2015 The device aids in the prevention of deep vein thrombosis. Read More
Noven Pharmaceuticals Hit With 13-Item Form 483 October 23, 2015 The 483 cites lapses in batch reviews and testing, stability and process controls, and complaint handling. Read More
Cohera Medical Secures $50 Million in Financing October 22, 2015 The financing will support U.S. marketing of its TissuGlu surgical adhesive. Read More
Biotech Investment Stagnates in Third Quarter October 22, 2015 Investment totaled $2.1 billion in the third quarter of 2015. Read More
Capsule Receives 510(k) Clearance for SmartLinx Vitals Plus October 21, 2015 The patient monitoring system integrates vital signs monitoring and clinical documentation into one scalable platform. Read More
FDA Turns Down Pfizer’s Bid to Market Rheumatoid Arthritis Drug October 21, 2015 The FDA is asking for more analyses of Xeljanz’s safety in treating patients with moderate to severe chronic plaque psoriasis. Read More
Biophor Diagnostics Receives 510(k) Clearance for Seventh Oral Fluid Screening Assay October 20, 2015 The assay is for d-methamphetamine at a 50 ng/mL cutoff. Read More
U.S. Opposes Permanently Exempting Poor Countries From Drug Patent Laws October 20, 2015 The plan has the support of the European Commission. Read More
Lightpoint receives CE Mark for LightPath Imaging System October 19, 2015 The system is designed to ensure removal of all cancerous tissue. Read More
FDA Details CMC Information for Gene Therapies With Microbial Vectors October 19, 2015 Firms should provide detailed information about the treatments’ composition and development process. Read More
Valeant Completes Acquisition of Synergetics USA October 16, 2015 Synergetics focuses on the fields of ophthalmology and neurosurgery. Read More