Astellas signs deal with Courtagen for mitochondrial disease drug development | FDA approves modified dosing regimen for BMS' Opdivo | Pfizer's breast cancer drug gains EMA committee support
September 19, 2016
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Astellas signs deal with Courtagen for mitochondrial disease drug development
Astellas Pharma and Courtagen Life Sciences signed a collaboration deal for the Phase I development of treatments for mitochondrial disease. The agreement calls for Astellas to develop a predictive model to evaluate drug candidates for mitochondrial disease using Courtagen's ZiPhyr bioinformatics platform.
GenomeWeb Daily News (free registration) (9/16) 
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Health Care & Policy
FDA approves modified dosing regimen for BMS' Opdivo
The modified dosage regimen for Bristol-Myers Squibb's Opdivo, or nivolumab, has been approved by the FDA for the treatment of advanced renal cell carcinoma, unresectable or metastatic melanoma and metastatic non-small cell lung cancer. The drug is now recommended as a 240-mg intravenous, flat-dosing regimen every two weeks until intolerable toxicity or disease progression.
CancerTherapyAdvisor.com (9/16) 
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Pfizer's breast cancer drug gains EMA committee support
The European Medicines Agency's Committee for Medicinal Products for Human Use has endorsed the approval of Pfizer's Ibrance, or palbociclib, for the treatment of HR-positive, HER2-negative metastatic breast cancer to be used either in combination with an aromatase inhibitor as a frontline therapy or combined with fulvestrant for patients who received prior endocrine treatment. The recommendation was backed by positive findings from three separate randomized trials.
OncLive (9/16),  Reuters (9/16) 
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Ipsen's kidney cancer drug wins EU nod
Ipsen's Cabometyx, or cabozantinib, has been approved by the European Commission as a treatment for adult patients with advanced renal cell carcinoma who received prior VEGF-targeted therapy. The approval was based on late-stage trial data and covers three dosage strengths.
European Pharmaceutical Review (U.K.) (9/16) 
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FDA to discuss BsUFA reauthorization
A public meeting will be held by the FDA on Oct. 20 for the reauthorization of the Biosimilar User Fee Act, which will expire Oct. 1 of next year. The agency's recommendations for reauthorization include permitting additional communications between the FDA and applicants and extending the review period by 60 days.
BioCentury (9/16) 
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LEO Pharma's psoriasis treatment backed in Scotland
The Scottish Medicines Consortium has recommended National Health Service use of LEO Pharma's Enstilar, or calcipotriol/betamethasone dipropionate, for use in managing plaque psoriasis in adults. The treatment was approved in Europe earlier this year.
PharmaTimes (U.K.) (9/15) 
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Company & Financial News
Diabetes treatment developer gets $215M funding boost
The first close of an equity financing round has generated $215 million for Intarcia Therapeutics, a Boston-based biopharmaceutical firm targeting a total of $600 million in the funding round. The company expects to file an application with the FDA within two months for ITCA-650, or exenatide, a once- or twice-yearly drug-device therapy for type 2 diabetes.
The Business Journals (tiered subscription model)/San Francisco (9/15),  FinSMEs (9/15) 
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Food & Agriculture
Syngenta biotech maize OK'd in EU
Eleven varieties of Syngenta's biotech maize have been approved by the European Commission for use as food or animal feed. The authorization, which is valid for 10 years, comes after a positive assessment by the European Food Safety Authority.
Reuters (9/16) 
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Industrial & Environmental
Study shows greater carbon benefits of biodiesel from soybean oil
A Purdue University study said biodiesel produced using soybean oil may be more carbon-friendly than previously thought, with emissions from induced land use change possibly up to 70% lower than credited by the California Air Resources Board. The study was welcomed by the biofuels industry, and the National Biodiesel Board's Don Scott said it confirms that "biodiesel reduces [greenhouse gas] emissions by at least 50% and suggests that the real benefit is greater than 80%."
DTN/The Progressive Farmer (9/15) 
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Partnering is open for the BIO Investor Forum
The BIO One-on-One PartneringTM system is now open for the BIO Investor Forum, Oct. 18-19, 2016, in San Francisco, an international biotech investor conference focused on investment strategies, trends and opportunities for the industry's most transformational and established private companies as well as emerging public companies. Meet with your peers from public and venture-stage growth companies, and top public and private equity investors, to explore potential partnerships and business collaborations to fuel research and development for promising innovation. The event also features plenary sessions, business roundtables and therapeutic workshops and company presentations. Learn more & register.
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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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