Related to NIH and FDA Taking Partnership for Regulatory and Translational Science One Step at a Time

• Chilly Budget Climate All but Freezes Proposed FY ’12 Spending for NIH and CDC
  Senate approved a 0.6% decrease in NIH’s budget and a 1% drop in CDC’s compared to fiscal 2011 levels.
  
• Germany Anchors Translational Medicine Efforts with New Spending Plan and Centers
  Country hopes framework will augment alliances among its institutes as well as assuage industry drug pricing concerns.
  
• Latest Gene Therapy Disapproval Points to Confusion over Regulatory Setup
  Gene therapy developers also need to keep an eye on demonstrating efficacy.
  
• NIH Funding Plagued by Potential of Continuing Resolution and Sequestration Measures
  As elections approach, likelihood of a spending bill covering institute or deficit reduction plan seems bleak.
  
• NIH Spending Barely Budges, CDC Stays Flat as Congress Finalizes FY 2012 Budget
  NIH will see a 1% increase and CDC a 0.6% increase over FY ’11 under a $1 trillion spending plan passed by the House and Senate.
  
• FDA New Drug Approvals in 2011 Outpace Recent Past
  Agency sanctioned 35 new medications including two with companion diagnostics.
  
• Review of NIH Grants in 2011 Shows Top Five Recipients Same as Last Year’s
  Johns Hopkins University came in first with $637.552 million, 4% more than last year.
  
• EMA’s Draft Rules for Interferon Beta Biosimilars Include Clinical and Nonclinical Studies
  Guidance is now open to comments, and a final rule is expected by the middle of this year.
  
• NIH Expects to Have New Policies for Research Using Chimpanzees Next Year
  A working group has been established to review IOM’s findings and make suggestions for implementation.
  
• Policy Makers, Regulators Are Trying to Fortify Focus on Treating Superbugs
  Legislation and FDA rules have been slow to come, but all voice a sense of urgency.
  
• Latest Guideline Summary Document Solidifies EMA as Front Runner in Biosimilar Regulation
  Agency sought to answer various procedural questions that could come up during presubmission meetings.
  
• European Commission’s Definition Roils Industries with Eye on Nanomaterials
  Some argue that guidance is too narrow and will force companies into costly compliance procedures.
  
• Reports Acknowledge FDA Progress but Cite Concerns on Agency Priorities, Management
  A major area of concern is the lower number of drugs that get the go-ahead after first review.
  
• FDA Reform Legislation Emerges as Exception to Washington Gridlock
  Bill includes reauthorization of PDUFA, which adds fees for generic and biosimilar developers.
  
• Academia Increasingly Going Beyond Basic Research by Setting Up Translational Med Centers
  Facilities are a response to industry’s retreat from in-house R&D and deepening valley of death.
  
• As Politicos Posture, Advocates Assess the Impact of Sequestration on Federal Agencies
  NIH estimates a 7.8% cut, while FASEB projects that number could go as high as 11.1%.
  
• Gene Therapy Society Looking to NIH to Revisit Role of the Recombinant DNA Advisory Committee
  Goal is to restrict involvement in clinical trials and focus the RAC on questions of public concern.
  
• NIH Taps 25 Schools to Receive Top Dollars
  Did your alma mater make the list?
  
• Filling the Drug Translation Gap
  Translation-focused disease foundations could help bridge the gap between academia and industry.
  
• NIH Update: Too Much Is Not Enough
  A surfeit of data and postdocs drive NIH’s new programs, but funding is uncertain.