BioNTech partners with Genmab on cancer immunotherapies | FDA supports LOINC code use in pharmaceutical, biological submissions | Completed Pfizer-Hospira merger expected by year's end

May 20, 2015
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BioNTech partners with Genmab on cancer immunotherapies
BioNTech and Genmab agreed to collaborate on the research, development and marketing of cancer immunotherapies in a deal worth up to $15 million. Under the agreement, BioNTech will provide its expertise in immunomodulatory antibodies and onco-immunotherapy and will receive $10 million upfront and up to $5 million in potential additional payments, while Genmab will allow the use of its DuoBody platform. The firms will equally share ownership of the product and development and marketing costs. Genetic Engineering & Biotechnology News (5/19)
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FDA supports LOINC code use in pharmaceutical, biological submissions
The FDA is asking that biological and pharmaceutical submissions use the Logical Observation Identifiers Names and Codes standard to ensure that clinical research data standards are in line with U.S. health IT programs. The agency supports LOINC code adoption because clinical laboratories are using it and it will make data easier to be filed, understood and analyzed by clinicians. It is also recommending the codes because the Study Data Tabulation Model, which is the standard used for sharing laboratory test results in studies, supports LOINC code exchange. Regulatory Focus (5/18)
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Completed Pfizer-Hospira merger expected by year's end
Pfizer's $17 billion acquisition of Hospira is expected to close by the end of 2015, bringing such products as biosimilars and sterile injectables to Pfizer's pipeline. BioSpectrum Asia (5/19)
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J&J, Achillion Pharmaceuticals to collaborate on hepatitis C treatments
Johnson & Johnson and Achillion Pharmaceuticals formed a partnership to develop and commercialize the latter's hepatitis C drugs, including sovaprevir and ACH-3102. Under the terms of the agreement, Achillion is eligible to receive up to $1.1 billion in milestone fees and a $225 million investment from Johnson & Johnson. Reuters (5/19)
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Janssen's schizophrenia drug gains FDA approval
Janssen Pharmaceuticals has obtained approval from the FDA for Invega Trinza, a paliperidone palmitate injectable formulation, as a treatment for schizophrenia. The drug, which is administered four times per year, is expected to reach the market next month. PharmaTimes (U.K.) (5/19)
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Corbus receives FDA OK for cystic fibrosis treatment study
The FDA has approved Corbus Pharmaceuticals' application to begin a midstage study of Resunab, a synthetic oral drug, as a treatment for cystic fibrosis. The placebo-controlled trial will be initiated within the next three months and will enroll about 70 adult patients. Pharmaceutical Business Review Online (5/19)
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Medicago to spend $245M on vaccine manufacturing site in Canada
Medicago plans to invest $245 million to build a new vaccine production facility in Quebec City. The nearly 474,000-square-foot site is expected to produce 40 million to 50 million doses of the firm's seasonal flu vaccines each year and will include corporate and research facilities. The complex is expected to be completed by 2019. BioSpace (San Francisco) (5/19)
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Gene therapy developer could secure $115M in IPO
Celyad is preparing an initial public offering of stock that could raise up to $115 million. The Belgium-based firm specializes in the development of gene therapies for cancer and cardiovascular disease. Capital (5/18)
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The Latest From BIO ...
BIO announces new member benefit -- Executive Liability Protection through Aon Risk Solutions
BIO and Aon plc (NYSE: AON) join forces to offer members comprehensive coverage for executive liability insurance through the BIO Business Solutions®, the largest cost-savings program in the life sciences industry. Learn more.
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Food & Agriculture
Biotechnology improves food security, legislator says
Agricultural biotechnology offers the best solution for providing food to the estimated 9.6 billion people expected to populate the world by 2050 because biotech crops can increase production while reducing the use of water and pesticide, writes Rep. Mike Pompeo, R-Kan. The crops can also address malnutrition in developing countries, with the introduction of crops such as golden rice for vitamin A deficiency, Pompeo writes. Research has confirmed the safety of biotech crops, and labeling biotech foods would only cause confusion and lead to increased food prices, adds Pompeo, who co-sponsored the Safe and Accurate Food Labeling Act. Roll Call (free content) (5/19)
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FEATURED ARTICLE: Understanding the Power of the Pareto Principle
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Industrial & Environmental
Biofuels lead trend toward non-petroleum fuels in transportation
Non-petroleum energy sources were 8.5% of the fuel used by the transportation sector in 2014, the highest percentage since 1954, according to data released by the U.S. Energy Information Administration. The largest proportion of non-petroleum energy was supplied by biomass from corn-based ethanol, with natural gas, electricity and biodiesel also contributing. (5/18)
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News From BIO
Savings on environmental waste disposal services
BIO has partnered with Clean Harbors, one of the largest environmental services companies in North America. The new BIO-Clean Harbors program will offer members a full range of hazardous and nonhazardous material management and disposal services at special pricing and deep discounts, including 35% to 40% off list price on disposal, 15% to 20% off list price on transportation and materials, and 35% off list price on labor charges. In addition, the BIO-Clean Harbors program offers full online tracking, free site visits to assure compliance with state and federal laws, staff training support and much more. The program is available to BIO or participating state and regional association members at no additional charge. Learn more!
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