Why pharma's user fees don't buy special treatment from FDA An essay by Donald W. Light of the University of Medicine & Dentistry of New Jersey takes the FDA and the pharmaceutical industry to task, suggesting that industry user fees influence the FDA to approval harmful drugs, John LaMattina writes. There is no such conspiracy, LaMattina writes. User fees were instituted under a 1992 law to help the FDA hire more reviewers and help get the agency's review times in line with those in other countries. Reviews can and do still end with rejection, and "any suggestion of the FDA being beholden to the pharmaceutical industry due to the PDUFA user fees is comical to those familiar with the drug review process," LaMattina writes Forbes (8/7)
| AstraZeneca, Nektar amend licensing deal for constipation drug AstraZeneca and Nektar Therapeutics have revised their licensing agreement for naloxegol, or NKTR-118, an experimental treatment for opioid-induced constipation. Under terms of the new deal, Nektar will get $70 million if the FDA accepts a regulatory application for the drug and $25 million more if the application will be accepted by European regulators. AstraZeneca plans to submit the drug for review in September. The revised deal allows AstraZeneca to cancel the agreement if a cardiovascular study is required by the FDA before approval. American City Business Journals/San Francisco/BiotechSF blog (8/8) 23andMe, Genentech ask Avastin users to spit for science 23andMe and Roche's Genentech unit are collaborating on an effort to identify genetic mutations that determine how patients respond to the cancer drug Avastin. The InVite Study asks patients who have taken Avastin for certain types of cancer to submit a saliva sample and possibly a blood sample, and answer questions in an online survey about their cancer and experience with Avastin. The study is part of a larger trend to involve patients and integrate technology in medicine, health care communications expert John Nosta writes. Forbes (8/7)  | Report Track & Traceability
Commerce in Motion and JDA, surveyed 130 quality control, supply chain and operations professionals. The goal was to understand their ability to effectively track, trace, and recall products. Per the study financial cost is the greatest risk associated with the inability to trace items. Download the free report now to see where the Life Sciences industry stands on traceability. |
 | GSK launches $50M bioelectronics venture fund GlaxoSmithKline launched a $50 million strategic venture capital fund to further the development of so-called bioelectronics or electroceuticals, which use electrical impulses rather than chemicals or biological molecules to treat disease. Ultimately, nanoscale implants could be developed to encourage insulin production, correct muscle imbalances or regulate food consumption, for example. Reuters (8/8) | | Industrial & Environmental | Spanish group harvests first crop of algae biomass from wastewater Spain's FCC Aqualia said the first crop of wastewater-derived algae biomass has been harvested by the "All-gas" liquid biofuel project. "This original new approach to bioenergy means that Spain's 40-million population could power 200,000 vehicles every year with a single toilet flush," said project coordinator Frank Rogalla, who is also FCC Aqualia's director of innovation and technology. The project is partly funded by the EU, which put $9.46 million into the venture. Reuters (8/8) | Register today for the BIO Investor Forum, Oct. 8-9, in San Francisco The BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and One-on-One partnering meetings. 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. Register today. |  | Motivation is simple. You eliminate those who are not motivated." -- Lou Holtz, American football coach, sportscaster, author and speaker | | | 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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