• BioLineRx Ltd., of Jerusalem, said it received approval from Indian regulators to start the Phase II/III CLARITY trial of BL-1020, an oral GABA-enhanced antipsychotic for treating schizophrenia. Overall, the study is expected to be conducted at about 18 sites in India, 14 sites in Romania and four sites in Israel.
Advanced Cell Technology Inc. (ACT) is about to deliver good news from its Phase I/II trials of retinal pigmented epithelial (RPE) cells and perk up the prospects for human embryonic stem cell (hESC)-based therapies following Geron Inc.'s abrupt withdrawal from the field last week.
EUSA Pharma Inc.'s FDA approval of acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) means the privately held specialty pharma firm may now be poised for an exit.
Through a process of business combination, restructuring, refocusing and a change in leadership, the entity formerly known as Biocontrol Ltd., of London, has emerged as a new company based in the U.S. called AmpliPhi Biosciences Corp.
LONDON – Oxyrane Ltd. has raised $26.5 million in a fourth private round as it prepares to move its first enzyme replacement therapy into clinical development for the treatment of Pompe's disease.
Bavarian Nordic A/S moved its off-the-shelf therapeutic vaccine for prostate cancer, Prostvac, into a global, 1,200-patient Phase III registration trial.
• Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, received orphan drug designation from the European Medicines Agency for its hemophilia B gene therapy. A Phase I/II trial is ongoing with the treatment, which consists of an adeno-associated viral vector containing the human factor IX gene.
LONDON – Europe's pharmaceutical companies have thrown their weight behind a European Commission action plan to pool efforts in the fight against antibiotic-resistant infections, and are demanding higher prices for their drugs in return for the support.
Wilex AG is taking the unusual step of canceling a planned interim analysis of data from a pivotal Phase III trial of its clear cell renal cell carcinoma (ccRCC) drug Rencarex (girentuximab) and seeking permission from European and U.S. drug regulators to complete a final data analysis based on an amended protocol.