Related to Innovation Can Prosper in a Regulated Environment

• Barack to Business in 2009
  At least for the biotech sector, change is certainly here.
  
• Final Stimulus Package Provides $21.5B for Research
  Biggest winner seems to be the NIH, which will receive $8.5 billion for research grants.
  
• Biotech Industry Gears Up for Health Reform Push
  Don’t let innovation be forgotten, they urge.
  
• Obama Budget Greeted with Kudos Along with a Few Concerns
  While basic research is getting a boost, industry advocates point out that small biotech are still struggling.
  
• Opinion: Pathway for FOBs Should Balance Need for Competition and Need for Innovation
  Biotech industry should support innovations including those inherent in developing biosimilars, says James Bianco, M.D., principal founder, CEO, and director of Cell Therapeutics.
  
• Biotech and Generic Industries Lock Horns over Biosimilars
  Points of contention include data exclusivity, interchangeability, and clinical trial requirements.
  
• Patent Reform Battle Pits Biotech against High-Tech
  The former fears increased infringement due to lower damages under the Patent Reform Act of 2009 making its way through Congress.
  
• Supporters of hESC Research Ecstatic with President Obama’s Executive Order
  NIH guidelines will work for federally funded stem cells, but some say protocols are needed for all cell lines.
  
• Intellectual Property at Crossroads
  The convergence of the patent system with the regulatory system presents complicated issues.
  
• Potential Effects of Pending Biologics Legislation on the Patent Application Process
  While patent reform may get bumped to a later Congress, a resolution to biosimilars law may get passed as part of a healthcare reform bill.
  
• Opinion—Regulatory Planning Key for Emerging Technology Companies
  Strategies formed early help keep investors and partners happy as well as create a smoother development path.
  
• Clinical Trial Failures Further Signal Pancreatic Cancer’s Intractable Nature
  Researchers need to step out of the gemcitabine box and also take on the development of diagnostics for early detection.
  
• While Grateful for Recovery Act Funds, Experts Stress the Importance of Continued Robust Funding
  Academia is now beginning to leverage the money, but tool companies are still waiting to feel the impact.
  
• 2009 in Review: Headline-Making Stories in the Biotech Industry
  Even though last year was marred by the economic crash, the life science sector showed significant progress.
  
• Avastin: Time for a Predictive Test
  Roche’s strategy to expand the use of Avastin into the first-line and adjuvant settings is particularly dependent on identifying those most likely to see a benefit.
  
• Biomarkers Poised for Breakout Moment
  A passel of discussions at BIO highlight the importance of these disease-state indicators.
  
• Medical Uses for Marijuana No Longer in the Weeds
  New crop of companies are adding to the political debate and also providing clinical evidence.
  
• Court’s Halt of Federally Backed ESC Research May Impact Economic Growth
  If the injunction sticks, U.S. firms will likely send ESC research jobs abroad.
  
• 2010 in Review: Biotechnology Highlights
  Gene patenting and ESCs were back in the headlines along with breakthroughs in sequencing, syn bio, and other fields.
  
• Beckman Coulter on the Chopping Block?
  Some analysts believe it is not a question of who will buy the firm but if the firm will be bought.