  - BIO, PhRMA launch PDUFA database tracking system
BIO and the Pharmaceutical Research and Manufacturers of America have launched a database to track reviews under the FDA's Prescription Drug User Fee Act program and offer feedback. The PDUFA Tracking Database, officially begun April 1, will collect real-time information from PhRMA and BIO member companies about their experience throughout the FDA's drug review process. "The goal is to make sure that we are all doing a better job of providing the next PDUFA reauthorization with greater consensus and greater clarity about what's really needed to improve the process," said Sara Radcliffe, executive vice president of health at BIO. Regulatory Focus (6/25)        | Earn your MBA online from Northeastern University
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 - FDA receives feedback on biosimilar draft guidelines
The FDA is reviewing comments on its draft guidances for biosimilars after the feedback period closed last month. As of last week, the agency has conducted 40 out of 56 requested meetings on biosimilar development programs. "FDA is currently reviewing and considering all comments received from the May 11, 2012, public hearing docket and those from the draft guidance dockets as we move forward to finalize the draft guidances and determine plans for developing future policies on biosimilars, including guidance on clinical pharmacology data to support a demonstration of biosimilarity to a reference product," said Lisa Kubaska, a spokeswoman for the agency. Genetic Engineering & Biotechnology News (6/26) - BIO takes part in coalition on trade in India
BIO, along with 15 other business groups, has joined the Alliance for Fair Trade with India, a new coalition created to support greater action against "discriminatory" trade practices such as the weakened intellectual-property rights in India. The coalition said that in the next few weeks it would collaborate with members of Congress and the Obama administration to advance public-policy options that aid U.S. exporters in India. PharmTech.com (6/25) - FDA OKs expanded use of Astellas' Mycamine
The FDA granted Astellas Pharma US expanded approval to market Mycamine, or micafungin sodium, as an injectable treatment for acute disseminated candidiasis, candidemia, Candida peritonitis and abscesses, and esophageal candidiasis in patients at least 4 months old. The drug was also approved for the prevention of Candida infections in patients getting hematopoietic stem cell transplants. Pharmaceutical Business Review Online (6/25) - Sanofi CEO: Making drug data public could hurt investment in EU
The European Medicines Agency's publication of a draft policy that would make detailed data on drugs publicly available after they are approved could deter crucial investment in Europe, said Chris Viehbacher, CEO of Sanofi and president of the European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Research and Manufacturers of America has condemned EMA's plans to unveil clinical-trial information, saying it could weaken research incentives and harm business. Reuters (6/24)  | 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. |
 | Company & Financial News |  |  | | - Novozymes buys U.S. maker of bioyield enhancers
Novozymes agreed to acquire TJ Technologies of Watertown, S.D., which offers biological solutions to improve plant growth and boost yields, for an undisclosed amount. "Combining our existing products and leading global name with TJ Technologies' strong and proven portfolio, brands and regional market coverage will strengthen Novozymes' commercial position in important crop markets," Novozymes Executive Vice President Thomas Videbaek said. American City Business Journals/Raleigh/Durham, N.C. (6/25) | Food & Agriculture | | | | - AquaBounty: Push for biotech labeling spreads misinformation
AquaBounty Technologies criticized a farm bill amendment sponsored by Sen. Lisa Murkowski, R-Alaska, that would require mandatory labeling of biotech salmon. CEO Ron Stotish said he's more concerned with misinformation being spread about the firm's biotech salmon than the labeling proposal itself. "We continue to battle to communicate the reality of our product, but responsible people continue to misrepresent the facts. Senator Murkowski should know better, although we don't think that this amendment will become law," Stotish said. FoodNavigator (6/25) | Industrial & Environmental | | | | - Propel Fuels: Consumers are adopting biofuels at a fast pace
Propel Fuels, which offers E85 and biodiesel blends in California and Washington state, has seen quick uptake and customer loyalty to renewable fuels. "The one thing we really noticed is how rapid the adoption of renewable fuels is occurring. I think consumers have a better understanding of what renewable fuels are," said Chris LaPlante, Propel's marketing director. Convenience Store News (6/21)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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| News from BIO | | | | - Save on energy costs through BIO's newest cost-savings program
BIO has recently aligned with APPI Energy, an energy consulting firm, to assist member companies with reducing their energy expenses. APPI Energy, the preferred energy consultant of 140 trade associations and chambers of commerce nationwide, provides solutions to reduce electricity and natural gas costs at no risk or obligation to member companies. Through this program, APPI Energy offers specialized energy cost reduction services, including the identification of reliable and competitive energy suppliers for member companies and the obtaining of competitive bids from the preferred suppliers in deregulated energy markets. Learn more.
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