The FDA Wednesday afternoon granted accelerated approval with breakneck speed – more than five months ahead of its May 19, 2015, PDUFA date – to Amgen Inc.'s blinatumomab to treat patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, or B-cell ALL, a rare form of ALL. Read More
Naurex Inc. raised an $80 million series C to carry its fast-acting experimental depression therapy, the NMDA receptor modulator GLYX-13, into its first phase III study in mid-2015. Read More
LILLE, France – Big pharma's focus on early stage innovation is obviously good news for early stage innovators, particularly those who have managed to bring their projects through the valley of death, to the point where they have established technical proof of concept. Read More
Taking what CEO Adam Grossman called "a different spin on intravenous immunoglobulin [IVIG]" while "trying to provide a product that's very targeted, niche-focused, and is going to provide an advantage to a subset" of the patient population, Adma Biologics Inc. reported positive top-line phase III results in primary immune deficiency diseases (PIDD) with lead compound RI-002. Read More
LONDON – Evotec AG is lining up a three-armed deal with Sanofi SA, which will see it taking on responsibility for five preclinical oncology programs, assuming operational control of a 200-strong drug discovery facility and acting as chief scout for academic research projects on behalf of the French pharma company. Read More
HONG KONG – Aeterna Zentaris Inc. and Sinopharm A-think Pharmaceuticals Co. Ltd. signed an exclusive license and technology transfer agreement allowing Sinopharm A-think to develop, manufacture and commercialize Aeterna Zentaris' zoptarelin doxorubicin (AEZS-1-8) in China, Hong Kong and Macau. The drug is being developed to treat endometrial cancer. Read More
HONG KONG – The breakthrough discovery of a new type of immune cells may play a key role in development of a treatment for multiple sclerosis (MS), a multi-disciplinary National University of Singapore (NUS) research team reported in Cell Research. Read More
Puma Biotechnology Inc., of Los Angeles, said it will need to submit data from preclinical carcinogenicity studies with its new drug application (NDA) filing for PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. Consequently, the company plans to delay the proposed timeline for filing the NDA from the first half of 2015 until the first quarter of 2016. Read More
Lpath Inc., of San Diego, completed enrollment of its clinical trial evaluating Isonep in patients with wet age-related macular degeneration. The multicenter phase II trial enrolled patients who have not responded well to existing anti-vascular endothelial growth factor therapies including, Lucentis (ranibizumab, Genentech Inc./Roche AG), Avastin (bevacizumab, Genentech Inc./Roche AG) and Eylea (aflibercept, Regeneron Pharmaceuticals Inc./Bayer AG). Read More
Ocata Therapeutics Inc., of Marlborough, Mass., said it plans to offer 10 million shares of its common stock in an underwritten public offering under an existing shelf registration statement. As part of this offering, the company intends to grant the underwriters a 30-day option to purchase up to an additional 1.5 million shares of common stock. The offering has not yet been priced. Read More
Meda Pharmaceuticals Inc., of Goteborg, Sweden, and Cipla Ltd., of Mumbai, India, said they sued Apotex Inc., of Toronto, along with U.S. arm Apotex Corp., in Federal District Court in Delaware to enforce the Orange Book-listed patents covering Dymista (azelastine HCl/fluticasone propionate) nasal spray, in response to Apotex's submission to the FDA of an abbreviated new drug application and accompanying paragraph IV certification, seeking approval to market a generic version of Meda's Dymista prior to expiration of the Dymista patents. Read More
