| Today's Top Story |  |  | | - Insurers emerge as biggest barrier to biotech success, survey suggests
As the FDA's working relationship with drugmakers improves, cost-conscious insurers have emerged as the biggest threat to new biologic drugs' success, according to a survey. More than half the biotech executives responding to a California Biomedical Industry Report survey said health insurance reimbursement issues had become more difficult in the past year. "We're seeing a shift in concern from the FDA to insurance coverage," said BayBio CEO Gail Maderis. "From a company's very early days, corporate partners and venture capitalists now want to know that if a product gets to the market, will it be reimbursed?" Xconomy (1/7) | Health Care & Policy |  |  | | - NPS CEO gives insight into orphan drug pricing
When pricing a new biologic drug, developers consider medical value, direct and indirect costs, market size and insurers' willingness to pay, NPS Pharmaceuticals CEO Francois Nader said. In the case of drugs to treat rare diseases, such as NPS' Gattex, NPS will give grants to rare-disease organizations that will help patients pay, and the company will offer co-pay assistance. Forbes (1/3) - Gilead signs antibody licensing deal with MacroGenics
Gilead Sciences secured the rights to develop and commercialize MacroGenics' Dual-Affinity Re-Targeting technology-based products for as many as four undisclosed targets. MacroGenics could get as much as $30 million in licensing fees, up to $85 million for preclinical milestones and up to $1 billion in clinical, regulatory and marketing milestones plus royalties. Genetic Engineering & Biotechnology News (1/7) - Firms ally to develop multi-valent bacterial vaccine
Janssen Pharmaceuticals and GlycoVaxyn will develop a multi-valent bacterial vaccine using the latter's bio-conjugation technology as part of a licensing and research agreement. "Our recombinant DNA-based vaccine technology is particularly well-suited for polyvalent conjugate vaccines and should make the development and commercialization of these vaccines more feasible and reliable," GlycoVaxyn Chief Scientific Officer Michael Wacker said. The deal entitles GlycoVaxyn to an upfront payment and possible milestone fees. Pharmaceutical Business Review Online (1/7) | Company & Financial News |  |  | | | Global Developments |  |  | | - India plans tighter regulation of drug studies
The Indian government plans to change laws governing drug trials to make violations by multinational corporations punishable and to improve compensation. Rules governing clinical studies under the Drugs and Cosmetics Act could be released this month. Trial investigators and sponsors would be required to address the medical management of subjects in cases of serious adverse events including death. The Economic Times (India)/Press Trust of India (1/4)  | |  |  | The Buzz(CORPORATE ANNOUNCEMENTS) |  |  | |  | | Food & Agriculture |  |  | | - TV chefs mislead public on biotech products, ex-critic says
High-profile chefs and other opinion leaders are spreading false information about biotech crops, environmentalist Mark Lynas said at the Oxford Farming Conference. Misinformation prevents the commercialization of biotech products that bring more food with less fertilizer, pesticide and fuel, he said. Lynas apologized for his opposition to biotech products in the 1990s. FoodNavigator (1/7) | Industrial & Environmental |  |  | | - Pilot-scale biorefinery to open this month in La.
The Louisiana State University AgCenter Audubon Sugar Institute is slated to open its pilot-scale biorefinery in St. Gabriel, La., on Jan. 25. The facility is expected to convert sweet sorghum, energy cane and other grasses into components for biofuels and renewable chemicals, said project manager Vadim Kochergin. The facility is part of a bigger initiative that received a $17.2 million grant from the U.S. Department of Agriculture's National Institute of Food and Agriculture. The Town Talk (Alexandria, La.)/The Associated Press (1/6) | 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. | SmartQuote |  |  | |  | It is wise to keep in mind that neither success nor failure is ever final." --Roger Babson, American entrepreneur and business theorist  | | | 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, January 07, 2013
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