PharmaMar cancer drug candidate licensed in Australia, Southeast Asia | Merck's Keytruda approved for 2 bladder cancer indications | Vertex's cystic fibrosis drug gets expanded indication
May 19, 2017
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PharmaMar cancer drug candidate licensed in Australia, Southeast Asia
PharmaMar's cancer drug candidate PM1183, or lurbinectedin, has been licensed to Specialized Therapeutics Asia for marketing in 12 Southeast Asian nations as well as New Zealand and Australia. Under the terms of the deal, PharmaMar will get an upfront payment and is eligible to receive payments tied to regulatory and sales milestones for the RNA polymerase II inhibitor.
Genetic Engineering & Biotechnology News (5/18) 
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Health Care & Policy
Merck's Keytruda approved for 2 bladder cancer indications
Merck's Keytruda, or pembrolizumab, has been approved by the FDA as a first-line treatment in patients with locally advanced/metastatic urothelial carcinoma who do not respond to chemotherapy that contains cisplatin. The agency also approved Keytruda as a second-line treatment in patients with advanced/metastatic UC whose disease progressed on or after platinum-containing chemotherapy or within one year of neoadjuvant treatment with the chemotherapy.
Seeking Alpha (free registration) (5/18) 
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Vertex's cystic fibrosis drug gets expanded indication
Vertex Pharmaceuticals' Kalydeco, or ivacaftor, has been approved by the FDA to cover 23 new disease-causing mutations in patients with cystic fibrosis based on data from an in-vitro cell study. The updated label indicates Kalydeco as a treatment for patients at least 2 years old with any of 33 mutations of the CF transmembrane conductance regulator gene who are responsive to the drug.
BioCentury (5/17) 
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FDA fast-tracks depressive disorder drug from Sage
Sage Therapeutics' drug candidate SAGE-217 has been granted fast-track designation by the FDA as a treatment for major depressive disorder. The company has an ongoing midstage clinical development study of the drug, including four trials for movement and mood disorders.
eMPR (5/18) 
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BLA for migraine drug filed by Amgen
A biologics license application has been submitted to the FDA by Amgen for its erenumab as a prevention drug for migraine. Erenumab will be co-promoted with Novartis' CGRP receptor inhibitor if approved by the agency.
Seeking Alpha (free registration) (5/18) 
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FDA grants breakthrough status to GlycoMimetics' leukemia drug
Breakthrough therapy status has been granted by the FDA to GlycoMimetics' GMI-1271 as a treatment for adult patients with relapsed/refractory acute myeloid leukemia. The company has an ongoing midstage trial to evaluate the combination treatment of GMI-1271 with chemotherapy in AML patients.
Seeking Alpha (free registration) (5/17) 
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Leukemia drug clofarabine available as generic in US
Fresenius Kabi has begun marketing a generic version of Genzyme's Clolar, or clofarabine, in the US. The single-dose vial is indicated for the treatment of relapsed or refractory acute lymphoblastic leukemia in patients ages 1 to 21 years.
Drug Store News (5/16) 
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Company & Financial News
Noxxon, German center to collaborate on cancer trial
The National Center for Tumor Diseases in Germany has entered into an agreement with Noxxon Pharma to conduct a Phase I/II study of Noxxon's Spiegelmer drug candidate NOX-A12, or olaptesed pegol, and Merck's Keytruda, or pembrolizumab. The drugs are being developed for metastatic pancreatic and colorectal cancer indications.
Genetic Engineering & Biotechnology News (5/16) 
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The BIO Business Solutions® program with Airgas offers a broad range of gases in all modes of supply; dry ice; cryogenic storage; gas handling equipment; and supplies and provides preferred pricing and 10-25% discounts on equipment and supplies and customized local solutions.
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Food & Agriculture
Scientist: Biotech crop tools mimic workings of nature
The National Academy of Sciences has found that concerns are growing about biotech crops, but genetic engineering of crops is simply a way of copying natural processes that have always shaped species, says Asheville, N.C.-based agriculture scientist and educator Jack Britt. "The same organism that is used by scientists to move genes into corn, soybeans, papaya, canola, alfalfa and other [biotech] crops has been moving genes across species naturally for a long time," Britt said.
Mountain Xpress (Asheville, N.C.) (5/17) 
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Industrial & Environmental
Novozymes to expand enzyme production in Neb.
Novozymes said it will expand its operation in Blair, Neb., that makes enzymes for the production of ethanol from agricultural byproducts. The $36 million project will increase the facility's fermentation capacity by about half, plant manager Kyle Nixon said.
KETV-TV (Omaha, Neb.) (5/22) 
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News From BIO
Registration for BIO 2017 World Congress now open
The Biotechnology Innovation Organization (BIO) announced registration and housing are now open for the 2017 World Congress on Industrial Biotechnology. The conference will be held July 23-26, 2017, at the Palais des congres de Montreal in Montreal. Register now.
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Great artists are people who find the way to be themselves in their art. Any sort of pretension induces mediocrity in art and life alike.
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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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