Takeda, Maverick sign $125M cancer therapy collaboration | FDA finalizes guidance on naming of biologics and biosimilars | RedHill Bio gets FDA QIDP status for antibiotic
January 13, 2017
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Takeda, Maverick sign $125M cancer therapy collaboration
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.
Genetic Engineering & Biotechnology News (1/11) 
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Health Care & Policy
FDA finalizes guidance on naming of biologics and biosimilars
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.
Regulatory Focus (1/12) 
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RedHill Bio gets FDA QIDP status for antibiotic
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.
Seeking Alpha (free registration) (1/11) 
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Biocon, Mylan's breast cancer biosimilar drug to be reviewed by FDA
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.
Seeking Alpha (free registration) (1/11),  Business Standard (India) (1/12) 
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Novo Nordisk's diabetes treatment gets EU OK
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.
PharmaTimes (U.K.) (1/11) 
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EU renews conditional marketing nod for DMD treatment from PTC
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.
PharmaBiz.com (India) (1/11) 
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Company & Financial News
NCI initiative aims to accelerate cancer studies
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.
Regulatory Focus (1/11),  The Washington Post (tiered subscription model) (1/11) 
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Funding round brings in $15M for OncoImmune
A round of Series A financing generated $15 million for Rockville, Md.-based OncoImmune. The firm's lead candidate is being tested in a midstage study for the prevention of graft-versus-host disease.
BioCentury (1/12) 
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Food & Agriculture
India's think tank urges use of biotech seeds
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.
The Economic Times (India) (1/12) 
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Industrial & Environmental
Corn ethanol yields better GHG benefits than expected, analysis finds
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.
Reuters (1/12),  EthanolProducer.com (1/12) 
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News From BIO
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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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Steve Jobs,
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
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