Roche, Exelixis to submit melanoma combo for regulatory review | FDA could soon approve Salix's chronic pain drug | Ventrus signs all-stock merger deal with Assembly Pharma
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July 15, 2014
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Roche, Exelixis to submit melanoma combo for regulatory review
Roche and Exelixis plan to file regulatory applications this year for approval to market a combination of cobimetinib and vemurafenib as a treatment for advanced melanoma after obtaining positive results in a late-stage trial. Data from the trial showed that previously untreated patients with advanced melanoma who took the combination therapy lived significantly longer without their disease progressing compared with those who received vemurafenib alone. Genetic Engineering & Biotechnology News (7/14), Reuters (7/14)
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Health Care & Policy
FDA could soon approve Salix's chronic pain drug
Salix Pharmaceuticals announced that the FDA has shown intent to approve an injectable formulation of its drug Relistor for the treatment of chronic pain in patients without cancer. The agency asked Salix to submit additional data from post-marketing observational studies, and Salix plans to submit the information within the next few weeks. The News & Observer (Raleigh, N.C.)/.Biz blog (7/14)
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Company & Financial News
Ventrus signs all-stock merger deal with Assembly Pharma
Ventrus Biosciences and Assembly Pharmaceuticals agreed to merge under an all-stock transaction to form a single organization that will focus on developing treatments for hepatitis B infection. The combined company, which will be called Assembly Biosciences, also plans to develop microbiome-based treatments for gastrointestinal infections. Genetic Engineering & Biotechnology News (7/14)
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Scripps researchers receive $2.6M in funding from NIH
The Scripps Research Institute has received $2.6 million from the National Institutes of Health to support the production of mesenchymal stem cells for research use. The team will accept requests for available cell lines and cell lines generated from specific types of mice for use in clinical trials. The project also aims to study cell properties for use in predicting human cell behavior through animal models. Genetic Engineering & Biotechnology News (7/14)
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N.Y. cancer Dx firm receives $1M funding boost
Empire Genomics, which specializes in cancer diagnostics, has raised $1 million in a recent funding round. The Buffalo, N.Y.-based company will use the funding to grow its portfolio of tests, expand its workforce and obtain new technologies. (7/11)
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Global Developments
Orphan status awarded to Zafgen's Prader-Willi syndrome drug in EU
European regulators have granted orphan-drug designation to Zafgen's experimental drug beloranib as a treatment for Prader-Willi syndrome. The designation will give the firm 10 years of market exclusivity in the European Union once the drug is approved. Zacks/Analyst blog (7/14)
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TPP negotiators could discuss drug patents in September
Trans-Pacific Partnership negotiators are expected to meet again in early September to address difficult issues including intellectual property rights protections for drugs after making progress on labor during talks in Ottawa. Possible venues for the meeting include the U.S., Mexico and Vietnam. The Japan News by The Yomiuri Shimbun (7/13)
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Featured Press Releases
Food & Agriculture
State biotech labeling laws may frighten rather than inform
Biotech labeling laws should be implemented on the national rather than the local level, according to this editorial. Instead of providing information about biotech products, state-by-state labeling laws could create unnecessary fear against biotech foods, which have long been proven to be safe for human and animal consumption. Chicago Tribune (tiered subscription model) (7/15)
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Industrial & Environmental
Report: World biofuel output to rise more than 50% through 2023
Ethanol and biodiesel production is expected to increase by more than 50% through 2023 to 41.7 billion gallons and 10.6 billion gallons, respectively, according to a new report from the U.N.'s Food and Agriculture Organization and the Organization for Economic Cooperation and Development. Increased demand, elevated oil prices and government incentives will drive the expansion, but it will be "a significant slowdown" from the doubling of production that occurred from 2004 through 2013, the report states. Reuters (7/11)
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Pareto signs synthetic-biology pact with DNA2.0
Pareto Biotechnologies agreed to combine its synthetic biology pipeline technology with DNA2.0's ProteinGPS engineering platform to expedite the engineering of proteins in Pareto's pipeline to create improved synthetic genes. The deal also gives Pareto the right to use DNA2.0's technologies to boost the efficacy of its own technology to produce flavors, fragrances and cosmetics with better properties. GenomeWeb Daily News (free registration) (7/14)
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News From BIO
Announcing the BIO Latin America Conference!
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