Quicker FDA approval via breakthrough status lauded by drugmakers Some drugmakers whose treatments obtained breakthrough therapy status from the FDA said the new regulatory pathway could speed the country's traditional drug approval process by years. Johnson & Johnson's Dr. Jay Siegel said he expects an FDA review of the company's candidate cancer drug ibrutinib that is faster by two years. Communications under the breakthrough designation can be accomplished in minutes rather than weeks and months, said Vertex Pharmaceuticals CEO Dr. Jeffrey Leiden. Reuters (7/24)  | Global Oncology Trial Management Strategies This complimentary white paper from Novella Clinical will help small- to mid-size pharma and biotech companies develop effective operational study plans, create robust and realistic feasibility studies and navigate regulatory submissions across multiple countries. Download: Global Oncology Trials - Planning for Success. | | FDA advisers recommend against wider use of AbbVie's Humira An FDA advisory panel voted 12-1 against recommending the expansion of the approval of AbbVie's Humira, or adalimumab, to include treatment for nonradiographic axial spondyloarthritis. The panel asked for more trials to determine whether the drug can be used in patients who don't respond to nonsteroidal anti-inflammatory drugs or who can't tolerate them. PharmaTimes (U.K.) (7/24), Reuters (7/23) Roche's obinutuzumab outperforms rituximab in late-stage study Roche Holding's investigational drug obinutuzumab, in combination with chemotherapy, slowed the progression of chronic lymphocytic leukemia better than rituximab in a late-stage trial. Obinutuzumab is a monoclonal antibody that stimulates a patient's immune system to fight cancer cells. Reuters (7/24)  | Report Track & Traceability
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 | Galapagos hits milestone in osteoarthritis alliance Servier paid Galapagos about $4 million in milestone fees for identifying new small molecules against a novel target for osteoarthritis. "Today's achievement is consistent with our strategy to move multiple, novel mechanism-of-action programs toward the clinic, thereby increasing the chances of success in disease areas with high unmet medical needs," said Onno van de Stolpe, Galapagos' CEO. Genetic Engineering & Biotechnology News (7/23)  | Getting Ready for the Physician Payment 'Sunshine' Rule
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 | | Industrial & Environmental | Iowa company seeks to get cellulosic ethanol from corn kernels Quad County Corn Processors plans to extract cellulosic ethanol from corn kernels, as an alternative to using cornstalks or switchgrass. "We're trying to utilize feedstock that's already on site," said General Manager Delayne Johnson. This could boost ethanol yield by about 6% in the fermentation process, Johnson added. MidwestProducer.com (7/23) | Join us Nov. 11-13 at the BIO Convention in China in Beijing! The BIO Convention in China brings together executives from biotechnology, pharmaceutical companies and investment firms from North America, Europe and Asia to meet and explore business opportunities with China's emerging biotech sector. BIO is renowned for its successful business development, partnering and investor meetings in North America, Europe and Asia. Partnering at this conference will be powered by BIO One-on-One Partnering, an interactive environment to intelligently search, contact and schedule private meetings with potential partners and investors. Learn more and register today. |  | One learns to itch where one can scratch." -- Ernest Bramah, English author | | | 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. | Please contact one of our specialists for advertising opportunities, editorial inquiries, job placements, or any other questions.
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