AstraZeneca’s Bydureon Pen Receives FDA Approval March 3, 2014 AstraZeneca has received FDA approval for its once-per-week Bydureon pen. Read More
EU Review Panel OKs New Formulation of Merck’s Antibiotic Noxafil February 28, 2014 The EMA’s CHMP issues positive opinion for tablet formulation of Merck’s antibiotic Noxafil. Read More
Qiagen Rolls Out HPV Test for Low-Resource Settings in India February 28, 2014 The launch of Qiagen’s careHPV Test brings cervical cancer screening to women in rural India. Read More
Review of Emergency Contraceptive Efficacy Moves to New Zealand February 27, 2014 New Zealand’s Medsafe joins other world regulators in investigating emergency contraceptives and their efficacy on heavier patients. Read More
Covidien Obtains Gets FDA Clearance for New Acute Care Ventilator February 27, 2014 The FDA has cleared Covidien’s acute care ventilator with advanced breathing technology for sale in the U.S. Read More
FDA Approves Iroko’s Low-Dose NSAID February 26, 2014 Iroko Pharmaceuticals wins FDA approval for low-dose painkiller following positive Phase III trial data. Read More
IMRIS’ Intraoperative CT Gets Green Light in Australia February 26, 2014 IMRIS announced Wednesday that its VISIUS intraoperative computed tomography system has been cleared for sale in Australia. Read More
Trial Results for InterMune’s Lung Drug Put Candidate Back in Play February 25, 2014 Study results from InterMune’s lung drug puts candidate back in play after FDA rejection in 2010. Read More
CSI Touts Benefits, Cost-Effectiveness of Diamondback 360 Coronary OAS February 25, 2014 One-year data show the Diamondback 360 Coronary OAS is reduces risks in patients with severely calcified lesions and is cost-effective. Read More
Takeda Announces Shift in Pharma Marketing for Japanese Units February 24, 2014 Japanese drugmaker realigns sales practices to bolster integrity, specializing representatives into one of three therapeutic areas. Read More
MRI Interventions, Siemens to Commercialize Software Platform for MRI-Guided Catheter Procedures February 24, 2014 MRI Interventions and Siemens announce plan for next-generation software platform for MRI-guided, catheter-based procedures. Read More
Hemangiol Scores EMA’s Second Positive PUMA Opinion February 21, 2014 CHMP approves Hemangiol through the EMA’s pediatric-use marketing authorization program to treat infantile haemangioma. Read More