EU panel backs approval of Pfizer's leukemia drug Bosulif

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January 22, 2013 BIO has teamed up with FedEx to offer member companies discounts of up to 35% off select FedEx Express, FedEx Ground and FedEx Home Delivery services through the BIO Business Solutions cost-savings program. Learn more. 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.   Today's Top Story    EU panel backs approval of Pfizer's leukemia drug Bosulif The European Medicines Agency's Committee for Medicinal Products for Human Use recommended that Pfizer's Bosulif, or bosutinib, be approved to treat patients with Philadelphia chromosome-positive chronic myelogenous leukemia who didn't respond to or can't tolerate other treatments. The drug, a tyrosine kinase inhibitor, was cleared by the FDA in September. Pharmaceutical Business Review Online (1/21), Medscape (free registration) (1/18)      Complimentary Webcast: GLP and GCP Auditing: Why Preclinical and Clinical Auditing Belongs in a Comprehensive Enterprise Quality Management System Learn: • The differences between GLP, GCP, and GMP auditing • How the TrackWise auditing solution can be used for GLP and GCP auditing • The benefits of using TrackWise for GLP and GCP auditing Download Now   Health Care & Policy    Apeiron licenses experimental neuroblastoma drug to Paladin Labs Apeiron Biologics granted Paladin Labs the exclusive rights to market its experimental drug APN311 in Canada and Sub-Saharan Africa. APN311 is an antibody-based immunotherapy being developed for treatment of high-risk pediatric neuroblastoma. The drug is in a late-stage trial in Europe. Genetic Engineering & Biotechnology News (1/18)      Augmenta secures patent related to universal flu vaccine target Augmenta Biologicals has been awarded a U.S. patent for technology designed to improve a the immune response to vaccines. The patent covers the company's universal flu vaccine target M2e, a viral peptide found in all flu strains. Pharmaceutical Business Review Online (1/21)      CSL Behring's hemophilia B treatment enters late-stage development CSL Behring has started recruitment for a pivotal, late-stage trial of rIX-FPits, a recombinant fusion protein that joins coagulation factor IX with albumin. The trial will evaluate the protein in children with hemophilia B. MedCityNews.com (1/21), Pharmaceutical Business Review Online (1/22)      GlycoMimetics proceeds with midstage trial of sickle cell disease drug GlycoMimetics wrapped up enrollment for a midstage study evaluating the safety, efficacy and pharmacokinetics of its experimental drug GMI-1070 in hospitalized sickle cell disease patients in vaso-occlusive crisis. Preliminary findings from the 76-patient trial could be released next quarter. Pharmaceutical Business Review Online (1/21)      Axelar kicks off Phase I/II trial of brain tumor drug Swedish firm Axelar began a Phase I/II trial to assess the efficacy of its investigational drug, AXL1717, in patients with relapsed or progressive malignant astrocytomas. The oral insulin-like growth factor 1 receptor pathway inhibitor is also undergoing a midstage trial for nonsmall-cell lung cancer. Pharmaceutical Business Review Online (1/21)      Earn American Airlines AAdvantage® miles from your business expenses and enjoy exclusive rewards and benefits • Earn 30,000 American Airlines AAdvantage® bonus miles* • First eligible checked bag is free* • Priority Boarding* • Double AAdvantage® miles on eligible business purchases* *Learn more.   Company & Financial News  BGI-Shenzen pushes back deadline for Complete Genomics cash offer BGI-Shenzhen extended until Friday its $118 million cash offer to acquire Complete Genomics as it waits for approval from the China's Ministry of Commerce and State Administration of Foreign Exchange. The acquisition has been approved by China's National Development and Reform Commission and the Federal Trade Commission in the U.S. GenomeWeb Daily News (free registration) (1/21)        Global Developments    ThromboGenics' eye drug Jetrea wins EU panel support ThromboGenics' Jetrea, or ocriplasmin, was recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for vitreomacular adhesion. The recommendation brings ThromboGenics one step nearer to $120 million in milestone fees from its partner Novartis, which holds the marketing rights to Jetrea outside the U.S. Bloomberg (1/18)      Two courses in four days at MIT Sloan Exec Ed Learn from world-renowned faculty at MIT Executive Education and make the most of your visit with back-to-back two-day courses. Understand big data, revitalize your digital business model, solve complex business problems, drive strategic innovation. View 25+ short courses.   Food & Agriculture  Monsanto gets clearance to grow biotech corn in Costa Rica Delta and Pine Land, a subsidiary of Monsanto, received permission from Costa Rica's National Biosecurity Technical Commission to grow biotech corn in the country for seed generation and research. The biotech seeds produced will be exported. The Tico Times (Costa Rica) (1/21)        Industrial & Environmental  Multi-feedstock waste-to-fuel project to move to demo scale A waste-to-fuel project led by researchers at the Washington State University Tri-Cities' Center for Bioproducts and Bioenergy is preparing to move to demonstration scale. The BioChemCat process for producing fuel can use farm waste from crops such as hops, wheat and grapes, said Keith Thomsen, assistant director of the center. "We can take anything, and we are not competing with food," Thomsen said. Tri-City Herald (Kennewick, Pasco and Richland, Wash.) (1/21)        News from BIO  BIOtechNOW BIOtechNOW is the first in a number of new products from BIO intended to enhance our communications with the biotech community -- not only with our members, but with other stakeholders as well. This e-newsletter, combined with its website, serves as our flagship in that effort. BIOtechNOW will offer original content that emphasizes the business needs of the industry; highlight BIO's advocacy efforts; and provide a portal to all BIO activities and events. Most importantly, it will spotlight for those outside the industry the value of biotechnology. Sign up for the e-newsletter.      Learn more about BIO -> Conferences  |  Join BIO  |  Media  |  Issues  |  Industry   SmartQuote  It ain't what they call you, it's what you answer to." --W.C. 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