| Today's Top Story |  |  | | | Health Care & Policy | | | | - FDA tweaks orphan drug rules
The FDA has finalized changes to rules implementing the Orphan Drug Act. Under the new rules, "orphan subset" means a drug is appropriate for use in a subset of the population but not in the broader population. The agency also clarified that a drug may qualify for incentives even if it could be used to treat multiple patient populations, as long as each one is less than 200,000 patients. Regulatory Focus (6/11)       - FDA expands use of Xgeva to include giant cell tumor of the bone
The FDA approved the use of Amgen's Xgeva, or denosumab, to treat adults and some adolescents with giant cell tumor of the bone when surgery is not an option. The decision makes denosumab the first approved drug for this condition. Xgeva, a fully human monoclonal antibody, was previously approved for treatment of osteoporosis and for prevention of skeletal-related events in adults with bone metastases and solid tumors. Medscape (free registration) (6/13) - Immune Design partners with 2 nonprofits on cancer immunotherapy
Immune Design will work with the Ludwig Institute for Cancer Research and the Cancer Research Institute to test a vaccine and adjuvant in ongoing clinical trials for other cancer immunotherapies. The Column Group, Versant Ventures and Alta Partners have invested $50 million in Immune Design, and the CEO expects to launch a new funding round soon. Xconomy/Seattle (6/12) | Company & Financial News | | | | - Firms ally to develop drugs for MS and other CNS diseases
Aphios and VivaCell Biotechnology España agreed to collaborate in the discovery, development and marketing of several drug candidates for multiple sclerosis and other neurodegenerative disorders of the central nervous system. The collaboration in the U.S. and Europe will center on a class of nonpsychotropic cannabinoids discovered by VivaCell with the University of Cordoba and Cajal Institute in Spain. Genetic Engineering & Biotechnology News (6/12) - Rothamsted gets green light to extend biotech wheat trial
The U.K. Department for Environment, Food and Rural Affairs granted Rothamsted Research approval to extend its biotech wheat field tests to include autumn-sown biotech wheat. The agricultural science institute is testing a wheat variety that produces (E)-beta-farnesene, a natural repellant for aphids that also attracts the insects' natural enemies, including wasps. Farmers Weekly Interactive (U.K.) (6/13)  | Webcast: A Conversation with The Johns Hopkins Hospital on Lowering the Cost of Healthcare from Inside Out
Learn how The Johns Hopkins Hospital uses its Integrated Asset and Service Management solution to improve uptime to support patient care; control costs for procurement, maintenance, labor and materials; support regulatory compliance activities; and use workflow capabilities for internal controls. Watch the webcast. |
 | Industrial & Environmental | | | | - USDA unveils new funding opportunities under energy programs
The Department of Agriculture is offering $98.6 million in funding assistance under the Advanced Biofuel Payment Program. Of that total, $68.6 million will be awarded for fiscal 2013 output, while the remainder will be allocated for production in previous fiscal years. The department also issued an amended notice increasing the amount of funds available and extending the application period to the Rural Energy for America Program for fiscal 2013. EthanolProducer.com (6/12) | News from BIO | | | | - Industrial biotechnology with a French twist!
Over 1,300 leaders in biofuels, biobased products and renewable chemicals will be in Montreal June 16-19 for the 10th Annual BIO World Congress on Industrial Biotechnology. Join the impressive list of attendees for great food, excellent wine, and a can't miss program which will feature plenary sessions, breakout tracks, workshops, investor sessions, poster presentations, an exhibit hall, networking receptions, and business partnering. BIO is excited to bring this conference to Montreal, highlighting the industry's growth and the importance for generating green jobs and producing greener products and cleaner processes, all aimed at building a biobased economy. Learn more.
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