- "Fiscal cliff" could stop or slow drug reviews come January
The Prescription Drug and User Fee Act might fall apart after only three months of implementation as lawmakers debate whether to follow through on a governmentwide budget reduction worth $1.2 trillion through 2021. Drug and device reviews might slow or stop in January because the FDA needs funding from Congress before it can spend the pharmaceutical industry's money, FDA spokeswoman Karen Riley said. At risk are fees from major drugmakers, which are set to pay nearly $2 million for every new-drug application, a $98,000 product charge and a $527,000 establishment fee starting Oct. 1. Bloomberg Businessweek (9/10), Pharmalot.com/Pharma Blog (9/10)        | Webinar: Complete Quality Management System Across the Enterprise - Thursday, 9/13 - 2:00pm EDT
Companies across the pharmaceutical and biotechnology industries need to protect their brands and reputations by delivering safe, effective, high quality products to the global market. Deploying a true enterprise quality management system has the inherent ability to harmonize all quality processes from each functional area, across all regions, and throughout the critical supplier network. Register Now! | |
| Health Care & Policy |  |  | | - Pfizer, Visterra to collaborate on antibody drugs
Visterra and Pfizer agreed to work together to discover and develop antibody drugs using Visterra's drug design platform. The deal entitles Visterra to an upfront payment and research funding plus milestone fees and sales royalties. VIS410, Visterra's lead candidate, is designed to help stop all influenza A strains by preventing the virus from entering cells. Genetic Engineering & Biotechnology News (9/11) - Study: Genentech's Tarceva slows return of nonsmall-cell lung cancer
A small study found that patients with early-stage nonsmall-cell lung cancer had two-year disease-free survival surpassing 90% after surgery and intake of Genentech's lung cancer drug Tarceva, or erlotinib. "Adjuvant erlotinib appears to have, at the very least, a cytostatic effect on micrometastatic disease," researcher Joel Neal said. "Only one patient recurred during treatment." MedPage Today (free registration) (9/10)  | Get More with The Business Platinum Card from American Express OPEN. EARN 25,000 MEMBERSHIP REWARDS® POINTS by spending $5,000 in the first 3 months of Card membership†.
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  | Company & Financial News | | | | - Annovation raises $8M to develop anesthesia drugs
Annovation BioPharma secured $8 million in a Series A financing round that involved Atlas Venture, Partners Innovation Fund and The Medicines Company. The firm will use the money to fund preclinical and clinical development of novel treatments in anesthesia and critical care. Xconomy/Boston (9/10)
| Food & Agriculture | | | | - Farm group withdraws opposition to Dow's biotech crop system
Save Our Crops, a group of U.S. farmers, said it will no longer oppose Dow AgroSciences' efforts to commercialize its Enlist biotech crop system after the adoption of "several new safeguards." Dow promised to add to the labeling instructions on the use of biotech crops and a reformulated herbicide, to educate applicators and farmers and to assist in the investigation of any reports of damage in nearby crops. Reuters (9/11) | Industrial & Environmental | | | | - Verdezyne CEO talks about future of biotech production of chemicals
 E. William Radany is president and CEO of Verdezyne, an industrial biotechnology company that turns fatty-acid distillates and other byproducts of vegetable oil processing into valuable types of polymers, polyamides and polyurethanes. The company's name, which means "green design," reflects its use of byproducts from renewable oils such as soy, canola, palm and coconut. Radany predicts that major chemical producers "will start partnering more extensively with renewable chemical companies like Verdezyne." AZoCleantech.com (Australia) (9/11) | News from BIO | | | | - Are you taking full advantage of your membership?
BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here.
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