Pfizer partners with cancer institute to test cancer drugs | Novartis' leukemia drug under priority review by FDA | Eagle Pharma begins rolling NDA submission for heat stroke treatment
November 15, 2016
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Pfizer partners with cancer institute to test cancer drugs
Pfizer and the National Cancer Institute's Center for Cancer Research have signed a cooperative research and development agreement under which three immunotherapy candidates from Pfizer will be studied in clinical and preclinical trials individually, in multiple combinations and combined with standard treatments. The research will include avelumab, a late-stage candidate being developed by Pfizer and Merck KGaA, and Pfizer's proprietary candidates utomilumab and PF-04518600.
Genetic Engineering & Biotechnology News (11/14) 
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Health Care & Policy
Novartis' leukemia drug under priority review by FDA
Novartis' new-drug application for PKC412, or midostaurin, has been accepted by the FDA for priority review as a treatment for newly diagnosed FLT3-mutated acute myeloid leukemia or advanced systemic mastocytosis in adults. The filing was backed by late-stage trial data involving AML patients whose risk of death was reduced by 23% compared with patients on chemotherapy, and a midstage study in patients with systemic mastocytosis that showed a 60% response rate to the treatment.
OncLive (11/14),  Reuters (11/14) 
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Eagle Pharma begins rolling NDA submission for heat stroke treatment
A rolling submission of a new-drug application for Ryanodex, or dantrolene sodium, has been initiated for FDA review by Eagle Pharmaceuticals. The firm is seeking approval for the drug as a treatment of exertional heat stroke.
Seeking Alpha (free registration) (11/11) 
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EU approves Janssen's treatment for Crohn's disease
Janssen's Stelara, or ustekinumab, has been approved by the European Commission as a treatment for moderately to severely active Crohn's disease in adults who did not respond adequately with a tumor necrosis factor alpha antagonist or conventional therapy or are contraindicated to such treatments.
Seeking Alpha (free registration) (11/11) 
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EU grants conditional approval to Eli Lilly's soft tissue sarcoma drug
The European Union has granted a conditional marketing approval to Eli Lilly and Co.'s Lartruvo, or olaratumab, for use with doxorubicin as a treatment for advanced soft tissue sarcoma in patients for whom treatment with radiotherapy or surgery is not an option. The decision was backed by midstage trial data demonstrating that the combination treatment induced a median survival gain of 11.8 months in patients with the disease who had not previously been treated with doxorubicin.
PharmaTimes (U.K.) (11/11) 
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Renewal of conditional approval for PTC's Duchenne drug endorsed by EMA panel
The renewal of the conditional marketing authorization for PTC Therapeutics' Translarna, or ataluren, has been endorsed by the European Medicines Agency's Committee for Medicinal Products for Human Use to treat Duchenne muscular dystrophy caused by a nonsense mutation in the dystrophin gene. The recommendation was based on available data, which the committee said showed that the drug poses no major safety risks and slows disease progression, but it is asking for more data to prove the benefit-risk balance.
Medscape (free registration) (11/11) 
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Company & Financial News
UK university awarded about $60,000 for cancer research
Masonic Charities has awarded the UK's University of Bradford a grant worth nearly $60,000 for cancer research. The university's Institute of Cancer Therapeutics will use the funding to develop new therapies.
Telegraph & Argus (U.K.) (11/12) 
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Global Developments
GSK, others aid drug access in developing countries
GlaxoSmithKline was again at the top of the list of drugmakers that have improved access to medications in developing countries, followed by Johnson & Johnson, Novartis and Merck KGaA, according to the independent Access to Medicine Index. The Access to Medicine Foundation creates the index by looking at 850 treatments for 51 diseases and ranks the top 20 global pharmaceutical companies on how accessible their medicines are in developing countries.
Reuters (11/14) 
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Food & Agriculture
Opinion: Indian farmers benefit from biotech crops
Biotechnology has transformed farmers' ability to earn a living, increasing plant productivity and reducing the need for pesticides by naturally repelling cotton pests such as bollworms, writes Aman Mann, a biotechnology graduate whose father is a smallholder farmer in India. "India has so much to gain from the latest agricultural technologies, which, for us in the developing world can make the difference between food security and malnutrition," Mann wrote.
The Des Moines Register (Iowa) (tiered subscription model) (11/14) 
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Industrial & Environmental
Alaska Airlines flight uses biofuel from wood waste
A jet fuel blend with 20% biofuel made from Pacific Northwest forest residuals powered an Alaska Airlines flight from Seattle to Washington on Monday. The biofuel blend was produced by Northwest Advanced Renewables Alliance, which is led by Washington State University.
The Seattle Times (tiered subscription model) (11/14) 
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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
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