Related to Crackdown on Biopharma Payments to Doctors

• 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.
  
• 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.
  
• Genzyme Plant Shutdown Could Mean up to $300M in Lost Sales
  Sales of drugs for Fabry, Gaucher’s, and Pompe diseases will take a hit.
  
• 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.
  
• Companies Step In to Fill Gap in Enzyme Replacement Therapy for Gaucher’s
  Shortage could lead to more choices for patients sooner than expected.
  
• Dendreon’s $70M Investment in Production Capabilities Could Woo Firms without Similar Expertise
  If cell-based immune therapy Provenge receives FDA sanction, it may corner a large market share and expand the company’s prospects.
  
• 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.
  
• Refocusing on Therapeutic Protein Production in Plants
  Recent contamination issues with Genzyme’s CHO-cell manufacturing has highlighted the advantages of plant-based techniques.
  
• 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.
  
• Osiris’ Race to Market an FDA-Approved Stem Cell Product
  Mesenchymal stem cell therapy Prochymal is in Phase III but still has challenges to overcome.
  
• 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.
  
• Changes Brewing at the FDA for Orphan Drugs
  Initiatives to de-risk drug development could include redesigning clinical trial requirements.