Takeda Pharmaceutical has entered into a collaboration with Maverick Therapeutics to develop the latter's T-cell redirection therapy platform for cancer treatments in a deal that could generate $125 million for Maverick. Takeda will pay an upfront option and equity fees, provide funding for research and development and also get the exclusive right to acquire Maverick for an undisclosed amount after five years.
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A final guidance on how biosimilars and biologic reference products must be named has been released by the FDA, stating that each biologic should receive a nonproprietary name with a meaningless, four-letter suffix attached to the end. The naming policy would be applied to newly licensed and previously licensed originator biological products, biosimilars and related biological products.
RedHill Biopharma's RHB-104, a combination antibiotic, has been granted a qualified infectious disease product designation by the FDA as a treatment for nontuberculous mycobacteria infections. The drug is under late-stage development as a Crohn's disease treatment.
The FDA has accepted Biocon and Mylan's biologics license application for MYL-14010, a biosimilar version of Roche Holding's Herceptin, or trastuzumab. A decision from the agency is expected by Sept. 3.
Novo Nordisk's Fiasp, a fast-acting insulin, has been approved by European regulators as a treatment for type 1 and type 2 diabetes in adults to be used in combination with basal insulin and as a continuous subcutaneous insulin infusion through an insulin pump. The firm plans to offer the product in Europe in the first half of the year.
The European Commission has allowed the renewal of a conditional marketing authorization for PTC Therapeutics' Translarna, or ataluren, as a treatment for nonsense mutation Duchenne muscular dystrophy in ambulatory patients at least 5 years old. The firm will be allowed to commercialize the drug in European Union member states as well as in Norway, Iceland and Liechtenstein.
The National Cancer Institute's new Cancer Therapy Evaluation Program will negotiate agreements between researchers and participating drugmakers to allow the use of specific agents in NCI-supported preclinical and clinical cancer studies. Six drugmakers have signed on to the initiative and agree to review proposals for listed agents within 60 days of receiving them from CTEP.
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The wider use of biotech seed varieties is being promoted by India's government think tank, NITI Aayog, or the National Institution for Transforming India, to spur agriculture growth in the country. In an appraisal document of its 12th five-year plan, the think tank noted that use of biotechnology for 20 years in the US has resulted in no adverse effects, and India has had its own success with Bt cotton.
Corn ethanol reduces greenhouse gas emissions by 43% compared with gasoline when measured on an energy-equivalent basis, according to an analysis prepared by ICF International for the US Department of Agriculture. The Environmental Protection Agency estimated a 21% reduction in 2010.
The BIO Asia International Conference, happening March 14-15, 2017, in Tokyo, Japan, brings together the global biotechnology and pharmaceutical industry to explore licensing and research collaborations in the current Asia-Pacific business and policy environments. Gain insights into the changes, challenges, and opportunities key opinion and policy leaders foresee for the Japanese biotech market. Learn more and register.
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