Related to EMA Road Map Aims to Stimulate Drug Development for Unmet Medical Needs and Rare and Neglected Diseases

• 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.
  
• 2010 in Review: Biotechnology Highlights
  Gene patenting and ESCs were back in the headlines along with breakthroughs in sequencing, syn bio, and other fields.
  
• Will Antibody Biosimilars See the Light of Day?
  Firms copying innovator therapeutic mAbs face manufacturing and regulatory challenges.
  
• 2011 Budget Outlook: Trim, Cut, Then Slash
  Agencies like the FDA and NIH are looking at potentially huge cuts.
  
• Study Finds a Friend at NIH but Will Congress Share the Love?
  Paper in NEJM tries to make case for boosting federal research funding amid House leaders’ pursuit of spending cuts.
  
• Opinion: Watson, Come Here … You're Needed at the PTO
  Without a transformation of the information technology supporting patent examiners, patent reform would be like rearranging the deck chairs on the Titanic.
  
• 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.
  
• Patent Reform Likely to Benefit Industry Giants More Than Start-Ups
  Points of concern in the America Invents Act include provisions for first-to-file and inequitable conduct.
  
• FDA Panel Hearing Suggests Medical Professionals May Play Role in Direct-to-Consumer Testing
  Changes including more regulation may take some time, as recommendations for the agency are yet to be finalized.
  
• 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.
  
• 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.
  
• House Takes Different Stance from Senate on Two Key Factors in Patent Reform
  While in number the amendments are small, their influence could be significant.
  
• NIH and FDA Taking Partnership for Regulatory and Translational Science One Step at a Time
  Over the past year, initiative named members, held two meetings, and gave out $9.4 million.
  
• Do Presidential Bioethics Committees Shape Science Policy?
  Panels help frame the debate, but topics are sometimes chosen more because of political pressure than scientific need.
  
• FDA Outlines Strategic Priorities but Action Is Further Out
  The agency will take at least another year to flesh out plans.
  
• FDA Tries to Address Some Concerns Over Nanotech in Biotech
  More details are needed, but developers now have a better idea of what constitutes nanomaterials.