 | Complimentary Whitepaper: Automated Audit Management Best Practices Learn how to: • Reduce audit time and cost • Mitigate risk • Improve product quality and safety • Facilitate compliance for industry regulations Download Now. | Health Care & Policy |  |  | | - Lab-developed diagnostics should be subject to FDA review
Regulation of laboratory-developed tests is long overdue, and FDA draft guidelines that have been delayed should be allowed to move forward, writes The New York Times' Editorial Board. While diagnostic tests created by device manufacturers are subject to FDA review, tests designed in the clinical lab have been exempt from premarket review. Because LDTs are being marketed much more widely now, they should be subject to the same review as other diagnostic tests, according to this editorial. The New York Times (tiered subscription model) (7/7) - Compromise on drug data transparency is necessary
Compromise is needed in developing a system that makes clinical trial data as transparent as possible, together with appropriate protections for important data related to drugmakers' commercialization efforts as well as research and development, John Sterling writes. PhRMA and other drugmakers are against the European Medicines Agency's plan to make clinical trial information publicly available once a new treatment is approved due to concerns over the release of commercially protected information including intellectual property data. Genetic Engineering & Biotechnology News (7/5) - Russian firm gains licensing rights to UCB's RA drug candidate
Russian drugmaker R-Pharm secured global rights to develop and market UCB's experimental drug olokizumab for all indications, but it will focus on rheumatoid arthritis. The deal entitles UCB to undisclosed upfront fee, milestone payments and sales royalties. UCB decided to stop developing olokizumab after midstage trial data showed indicated it was comparable but not superior to Roche Holding's tocilizumab. PharmaTimes (U.K.) (7/8) Company & Financial News |  |  | | Global Developments |  |  | | Food & Agriculture |  |  | | - N.J. business groups oppose biotech labeling bill
BioNJ and other business groups in New Jersey have criticized a bill that would require labeling of foods containing biotech ingredients, saying that the proposal would only create an impression that biotech foods are inferior and unhealthy. The bill "will create a significant expense and labor for restaurants in the state, and it does nothing to further the public good," said Marilou Halvorsen, president of the New Jersey Restaurant Association. "A government-mandated label has the very distinct possibility of confusing consumers," said John Holub, president of the New Jersey Retail Merchants Association. NJBIZ (New Jersey) (7/8) Industrial & Environmental |  |  | | - Sewage-to-biofuel project is unveiled in Spain
The All-gas project in Chiclana de la Frontera, Spain, will be the world's first wastewater plant to use sunlight to convert waste into biofuel for vehicle use. "Nobody has done the transformation from wastewater to biofuel, which is a sustainable approach," said All-gas project leader Frank Rogalla. "Carbon dioxide is used to produce algae biomass, and the green sludge is transformed into gas, a clean biofuel commonly used in buses or garbage trucks because it is less polluting," he added. DigitalJournal.com (7/7) News from BIO |  |  | | - 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. SmartQuote |  |  | |  | If there is no struggle, there is no progress." --Frederick Douglass, American social reformer, orator and writer  | | | This SmartBrief was created for jmabs1@gmail.com | | Read more at SmartBrief.com | A powerful website for SmartBrief readers including: | | | | | | Recent BIO SmartBrief Issues: - Monday, July 08, 2013
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