News

AdvanDx has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH tests. The faster protocol

Leo Pharma has reported positive results for the two phase III actinic (solar) keratosis (AK) clinical trials using PEP005 (ingenol mebutate) gel. It is meant for the treatment

Prasco Laboratories (Prasco) has signed a distribution and supply agreement with Stiefel Laboratories (Stiefel), a GlaxoSmithKline company, for Clobetasol Propionate Foam 0.05%, the latest product in Prasco’s line

Fibrocell Science has received a Complete Response letter from the FDA related to the Biologics License Application (BLA) for azficel-T, an autologous cell therapy for the treatment of

Mylan has reported that its subsidiary, Matrix Laboratories (Matrix) has received tentative approval from the FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR), for its New

Australia-based CSL has announced that the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study H1N1 2009 ‘swine’

Ablynx has presented results from the open label extension of the phase Ib study of its anti-thrombotic, ALX-0081, in patients with stable angina undergoing percutaneous coronary intervention (PCI).

Actelion has reported the results of an arbitration proceeding in California between one of its subsidiaries, CoTherix, and Asahi Kasei Pharma (Japan), regarding a license agreement to develop

Shire has submitted a Biologics License Application (BLA) to the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. Replagal first received marketing authorisation in