Related to 7 Biotech Trends for the Coming Year

• 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.
  
• 2011 Budget Outlook: Trim, Cut, Then Slash
  Agencies like the FDA and NIH are looking at potentially huge cuts.
  
• A Look at the Top Two Bio Clusters in the U.S.: California and Massachusetts
  Financing and workforce issues are at the top of their agendas for this year.
  
• Overview of the Number Three and Four Biotech Clusters in the U.S.
  North Carolina and Maryland are trying to start new funds to support start-ups.
  
• Review of the Second Tier of Biotechnology Clusters in the U.S.
  Colorado, Florida, New Jersey, Pennsylvania, and Washington gear up to boost growth plans while trying to balance budget woes.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance
  Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products.
  
• U.S. Lead in Nanotechnology Depends on Growth of FDA and Gov’t Initiatives
  European revenue from nanotech-enabled products is projected to surpass that of the U.S. by 2015, according to Lux Research.
  
• FDA Holds Public Discussion of User Fee Program for Biosimilars
  Initiative is one step in agency’s road to developing the final abbreviated approval pathway for biosimilars.
  
• What Will FDA Biosimilars Guidelines Mean for Industry?
  Agency hasn’t settled on requirements for interchangeability and exclusivity period for pioneer biologics.
  
• Enzo Sues Roche, Gen-Probe, and Life Technologies in Patent Infringement Case
  Patent under dispute expires in 2023, and defendants plan on fighting the lawsuit.
  
• Regulatory Environment Warms Up to Obesity Drugs and Could Heat Up Market
  With Vivus receiving a positive recommendation, analysts see CV risk as one that can be evaluated post-approval.
  
• Comments Sent to FDA on Its Draft Biosimilars Guidance Mostly Conveyed Discontent
  More rigorous testing to prove biosimilarity and safety were the biggest concerns.
  
• FDA’s Hearing for Biosimilars Showcased Issues Ranging From Definitions to Study Requirements to IP
  Industry appeared to provide broad support for draft rules but pointed to areas that need tweaking.
  
• Obesity Drug Developers Post Steady Gains
  High clinical trial costs and slower FDA approvals are among the hurdles to obesity drug approval.
  
• Meningitis Outbreak Prompts Policy Review
  Compounding pharmacies anticipate new rules following the meningitis outbreak, including an answer to the longstanding question of federal vs. state oversight.
  
• Getting FDA to Yes
  As PDUFA, patent cliff drive 2012 approvals, can industry keep cranking out new molecules?
  
• Legal Challenges to Healthcare Reform Threaten Biopharmaceutical Legislation
  Initiatives detailed in the Act, like those to boost personalized medicine and comparative effectiveness research, could be lost.
  
• Cliff Spells Danger for Biotechs
  If Obama and Congress cannot agree, key agencies face cuts while tax changes would dampen new investment.
  
• Biggest Biotech Trends of 2012
  GEN takes a look back at some key biopharma developments of the past 12 months.
  
• 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.