X-Chem partners with Ono on cancer drug-discovery programs | Parkinson's disease drug from Newron wins FDA nod | Humacyte's Humacyl gets FDA RMAT designation
March 22, 2017
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X-Chem partners with Ono on cancer drug-discovery programs
X-Chem and Ono Pharmaceutical have entered into a collaboration to develop cancer drugs using X-Chem's DNA-encoded DEX libraries. X-Chem will receive an upfront payment and research and licensing fees, and is entitled to development and regulatory milestone payments, while Ono gets the option to license certain compounds and develop and market programs arising from the collaboration.
Genetic Engineering & Biotechnology News (3/21) 
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Health Care & Policy
Parkinson's disease drug from Newron wins FDA nod
The FDA has approved Newron Pharmaceuticals' Xadago, or safinamide, as an add-on drug for patients with Parkinson's disease. Xadago is indicated for patients who already take levodopa/carbidopa but experience "off" episodes in which the treatment is not effective.
Reuters (3/21),  Pharmacy Times online (3/21) 
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Humacyte's Humacyl gets FDA RMAT designation
A regenerative medicine advanced therapy designation has been granted by the FDA to Humacyte's Humacyl, which was developed as a treatment for patients with kidney failure who can't receive fistula placement. Humacyte anticipates data from a late-stage trial of Humacyl by next year.
BioCentury (3/20) 
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FDA grants tentative approval to Mylan's HIV drug
The FDA has granted tentative approval to Mylan's efavirenz, lamivudine and tenofovir disproxil fumarate tablets, 400 mg/300 mg/300 mg, or TLE400, under the President's Emergency Plan for AIDS Relief. TLE400 will be available as a first-line treatment in patients with HIV-1/AIDS infection.
Reuters (3/20),  Seeking Alpha (free registration) (3/20) 
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Data show positive results for Lilly's late-stage trial of breast cancer drug
Eli Lilly and Co.'s LY2835219, or abemaciclib, met the primary endpoint of a late-stage study in which the drug showed significant improvement in progression-free survival when combined with Faslodex, or fulvestrant, in postmenopausal women with hormone receptor-positive, HER2-negative breast cancer, compared with Faslodex as monotherapy. The company intends to file a new-drug application to the FDA this year.
BioCentury (3/20) 
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Debiopharm to market triptorelin 6-month formulation to 22 EU countries
Switzerland-based Debiopharm International will market its Decapeptyl and Pamorelin 22.5 mg, a triptorelin 6-month formulation, to 22 European countries after the drug received approval for use in treating central precocious puberty. The formulation was already registered as a prostate cancer treatment to the same countries.
European Pharmaceutical Review (U.K.) (3/20) 
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Company & Financial News
University licenses brain cancer drug to Lin BioScience
Lin BioScience has been granted exclusive worldwide rights to develop and market the University of Sydney's blood-brain barrier permeable, small-molecule drug LBS-002 for brain cancer treatment. Financial details of the deal were not disclosed.
Genetic Engineering & Biotechnology News (3/21) 
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Funding round brings in $64M for SutroVax
A Series B financing round has pulled in $64 million for Sutro Biopharma spinout SutroVax. The funding will be used to support a midstage trial of the company's lead pneumococcal conjugate vaccine candidate.
BioCentury (3/21) 
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Food & Agriculture
Biotech crops and livestock get backing from UK royal
Princess Anne of Britain said biotech crops and livestock provide important benefits in food production and that she would grow them on her farmland. "Surely if we are going to be better at producing food of the right value, then we have to accept that genetic technology ... is going to be part of that," Princess Anne said.
Reuters (3/22) 
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Industrial & Environmental
Study: Engineering fungal cells could help in biofuel production
A team of researchers from Minnesota discovered that the endoplasmic reticulum, an organelle in fungal cells, synthesizes some sesquiterpenes that are a potential precursor to biofuels. Researchers suggest the sesquiterpene bisabolene may be a precursor to biodiesel, and biofuel and other valuable products could be generated by engineering the biochemical pathway in which the molecules are produced in fungal cells.
BiofuelsDigest.com (3/21) 
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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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