Related to T2cure’s Mid-Stage Somatic Stem Cell Product Receives EMEA Quality Certification

• 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.
  
• Geron’s Setback with Testing Its hESC Therapy in Humans Points to FDA’s Continued Cautionary Stance
  Data from animal studies prompted the clinical hold, which highlights the various kinks yet to be worked out.
  
• 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.
  
• 2010 in Review: Biotechnology Highlights
  Gene patenting and ESCs were back in the headlines along with breakthroughs in sequencing, syn bio, and other fields.
  
• What Will Succeed Lipitor as the Next Blockbuster Cholesterol-Lowering Drug?
  CETP inhibitors are vying to take over from statins, but one major failure hovers ominously.
  
• Will Antibody Biosimilars See the Light of Day?
  Firms copying innovator therapeutic mAbs face manufacturing and regulatory challenges.
  
• 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.
  
• 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.
  
• A Clearer Regulatory Pathway for Cell Therapy May Help Improve Investment
  In the U.S. and the U.K., gov’t and foundations play a key funding role as investors try to avoid the risk.
  
• 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.
  
• Genentech Prepares to Vouch for Avastin’s Use in Breast Cancer in FDA Hearing
  Company will present details on a so-called confirmatory study and biomarker data.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• Advocates Attempt to Advance Regenerative Medicine with Introduction of HR 1862
  Alliance must steer clear of hESC debate in pursuing regenerative medicine bill.
  
• Concurrent Dx/Rx Review Will Require More Collaboration at FDA and More Outreach by Industry
  Agency issued draft guidance on companion diagnostic approval on July 14.
  
• As Comment Period Ends, FDA Seeks to Clarify Conflict of Interest Rules
  Agency’s draft guidance should be coupled with HHS’ proposals from last year, which are still being reviewed.
  
• Efforts to Standardize Molecular Imaging Blossoms as Industry and Agencies Unite
  Firms are more interested in leveraging the value of this method in clinical development.
  
• U.S. Stem Cell Companies Find Partners and Revenues Beyond the Water’s Edge
  Firms find it easier to navigate regulatory requirements in Asia as well as Europe.
  
• Exploring Biology in Space May See a Slowdown with the End of NASA’s Shuttle Missions
  With the last shuttle taking off on July 8, scientists say they won’t have as many opportunities to conduct life sci research.