Celgene to develop metabolic immuno-oncology treatments with Agios | Bristol-Myers' lymphoma drug wins FDA approval | Asthma drug from AstraZeneca to be submitted for US, EU approval
May 18, 2016
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Celgene to develop metabolic immuno-oncology treatments with Agios
Celgene will collaborate with Agios Pharmaceuticals on the research, development and marketing of metabolic immuno-oncology treatments that will be based on the latter's cellular metabolism research technology. Under the terms of the agreement, Agios is entitled to receive an upfront payment of $200 million and as much as $169 million in milestone fees per program, while Celgene gets the right to designate collaboration programs and an option to expand the deal.
Genetic Engineering & Biotechnology News (5/17) 
Health Care & Policy
Bristol-Myers' lymphoma drug wins FDA approval
Bristol-Myers Squibb's Opdivo, or nivolumab, has received accelerated approval from the FDA as a treatment for patients with classical Hodgkin lymphoma who relapsed or experienced disease progression following hematopoietic stem cell transplant and brentuximab vedotin treatment. The decision was backed by results from two studies that showed Opdivo-treated patients had a 65% objective response rate.
OncLive (5/17) 
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Asthma drug from AstraZeneca to be submitted for US, EU approval
AstraZeneca announced plans to seek regulatory approval for its severe asthma treatment benralizumab in the US and Europe in the second half of this year after the drug achieved positive results in two Phase III studies. Benralizumab could be launched next year.
Reuters (5/17) 
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FDA OKs generic anesthetic treatment from Aurobindo
The FDA has approved the marketing of Aurobindo Pharma's bupivacaine hydrochloride injection in two dosages. The drug, which is a generic copy of the Marcaine injection from Hospira, is indicated for use as a regional or local anesthetic or analgesic.
LiveMint.com (India) (5/16) 
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Pulmonary arterial hypertension drug from Actelion gets EU approval
Actelion Pharmaceuticals won approval from European regulators for Uptravi, or selexipag, as a long-term treatment for pulmonary arterial hypertension patients. Uptravi was approved for use as a monotherapy or in combination with an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor. The approval was supported by late-stage trial data showing the drug resulted in longer time to a first morbidity or mortality event.
PharmaTimes (U.K.) (5/17) 
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Gilead to file for expanded approval of Truvada in S. Korea
Gilead Sciences said it will submit an application with the Korean Ministry of Food and Drug Safety in the second half of 2016 seeking expanded approval for Truvada, or emtricitabine and tenofovir disoproxil fumarate, as pre-exposure prophylaxis for HIV. A response from the agency is expected after June 2017.
The Korea Herald (Seoul) (5/17) 
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Company & Financial News
Novartis to divide into 2 business units
Novartis announced it will split its pharmaceuticals unit into separate drug and oncology businesses. Novartis' restructuring plan reflects its focus on oncology after consolidating GlaxoSmithKline's oncology products into its pipeline in 2015, the company said.
Reuters (5/17) 
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AbbVie, BMS expand Mass. facilities
Two facilities were opened Tuesday by Bristol-Myers Squibb at its Devens, Mass., site. The $280 million expansion project includes a biologics development building and a clinical manufacturing facility. Meanwhile, AbbVie will open its Foundational Neuroscience Center in Cambridge, Mass., today. It will be used for Alzheimer's disease research.
American City Business Journals/Boston (5/18) 
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Food & Agriculture
BIO pleased with study backing safety of biotech crops
BIO said it was pleased with a report from the National Academies of Sciences, Engineering, and Medicine showing that "agricultural biotechnology has many demonstrated benefits to farmers, consumers and the environment." The analysis said biotech crops can be safely consumed and pose no threats to the environment.
The New York Times (free-article access for SmartBrief readers) (5/18) 
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Industrial & Environmental
Release of 2017 RVOs imminent, exec says
Chris Novak, CEO of the National Corn Growers Association, expects the Environmental Protection Agency to release its 2017 renewable fuel volume obligations in the coming weeks. Novak said the Prime the Pump program and the USDA's biofuels infrastructure grant program can help boost dispensing of higher blends and weaken the EPA's argument for lower blending targets.
Brownfield (5/17) 
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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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