Biota Pharmaceuticals Inc., of Atlanta, said Daiichi Sankyo Co. Ltd., of Tokyo, has been granted regulatory approval in Japan to manufacture and market Inavir Dry Powder Inhaler 20 mg (laninamivir octanoate) for the prevention of influenza A and B.
Biotime Inc., of Alameda, Calif., said subsidiary Cell Cure Neurosciences Ltd., of Jerusalem, was awarded a grant for 2014 of 6.1 million shekels (US$1.74 million) from Israel’s Office of the Chief Scientist (OCS) to help finance the development of Opregen, a cell-based therapeutic product to treat age-related macular degeneration. Cell Cure will pay a royalty to the OCS on revenues from Opregen equal to 100 percent of the amount of the grant plus interest at a LIBOR rate. Cell Cure plans to complete preclinical testing and file an investigational new drug application to begin human trials in 2014. (See BioWorld Today, Dec. 10, 2010.)
Durata Therapeutics Inc., of Chicago, said the European Medicines Agency accepted for review a marketing authorization application for dalbavancin. Durata is seeking approval for the marketing and sale of dalbavancin for the treatment of patients with complicated skin and soft-tissue infections caused by susceptible gram-positive microorganisms, including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. The company anticipates a decision in the first half of 2015.
The Medicines Co., of Parsippany, N.J., said the European Medicines Agency accepted for review its marketing authorization application for the investigational intravenous antiplatelet agent, cangrelor, which is also under FDA review for use in patients undergoing percutaneous coronary intervention and those who require bridging from oral antiplatelet therapy to surgery. (See BioWorld Today, March 12, 2013, and Jan. 10, 2013.)
Probiodrug AG, of Halle/Salle, Germany, said it will provide research funding to the Center for Neurologic Diseases at Brigham and Women’s Hospital in Boston. Funded by the National Institutes of Health, the work is pioneering immunotherapy approaches to eliminate pyroglutamated (pGlu) Abeta, a highly toxic peptide that has been correlated with cognitive decline in individuals with Alzheimer’s disease, the company said. The funding provided by Probiodrug will be used to expand that work to include additional research aimed at understanding mechanisms of clearance using several experimental anti-pGlu Abeta monoclonal antibodies provided by Probiodrug.
Taigen Biotechnology Co. Ltd., of Taipei, Taiwan, said the FDA granted Taigexyn (nemonoxacin) qualified infectious disease product and fast track designations for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.