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- Early trials may be enough for experimental drugs to get FDA OK
The FDA granted "breakthrough" status to three promising experimental drugs as part of efforts to speed market entry for treatments of life-threatening conditions. "We expect many of these would come available very quickly with Phase 1 data," FDA Center for Drug Evaluation and Research Director Janet Woodcock said. Applications for breakthrough status have been made for 18 other treatments, she said. Bloomberg Businessweek (2/12)       | Genentech Hardly 'Resistant': Up to $111M in Deal with RQx | | Avalon Ventures scored again for the third time in recent weeks, as antibiotics-focused RQx Pharmaceuticals Inc. is expected to make public a deal worth as much as $111 million with Genentech, part of Roche AG. The agreement comes with an up-front fee, milestone payments and potential royalties, but the firm did not disclose amounts. Find out the details. |  |
| Health Care & Policy |  |  | | - EU hastens metastatic melanoma review for GSK drugs
The European Medicines Agency granted GlaxoSmithKline's request for accelerated review of trametinib as a monotherapy and in combination with dabrafenib for metastatic or unresectable melanoma in people with the BRAF V600 mutation. The accelerated schedule could make the drugs available within six months. PharmaTimes (U.K.) (2/12) - Biosimilars bills fail in Miss.
Bills that would have restricted pharmacists' ability to substitute biosimilar drugs for brand-name therapies failed to advance out of committees in the Mississippi House and Senate. Proponents say that pharmacists should be allowed to substitute only a biosimilar FDA-approved as "interchangeable" with the brand-name biologic drug for the specific indication and that doctors' orders to dispense as written should override payer policies. Opponents say the federal Public Health Service Act allows automatic substitution and the Mississippi legislation and other bills like it are simply an effort to protect drugmaker profits. Pharmalot.com/Pharma Blog (2/8) | Company & Financial News | | | | | Food & Agriculture | | | | | Industrial & Environmental | | | | - USDA sees slower demand growth for biofuel feedstocks through 2022
Global demand for ethanol and biodiesel feedstocks is expected to keep growing through the next decade, but the pace of growth will be slower compared with recent years, according to a Department of Agriculture report issued Monday. The U.S., Brazil, EU member states, Argentina, Canada, China and Indonesia will continue to be the biggest market players, with their combined output expected to increase 40% through 2022, the USDA said. EthanolProducer.com (2/12)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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| News from BIO | | | | - Ship with FedEx
FedEx is now offering member companies discounts of up to 35% off select FedEx services, both U.S. and international services. The BIO program with FedEx is one of the many cost-savings programs offered by BIO through its Business Solutions program. There is no charge for BIO member companies to participate in any of the BIO Business Solutions programs -- it is a benefit of membership. Learn more about the BIO and FedEx program.
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--Aldous Huxley,
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