Related to NIPTE Receives $35M from FDA to Reform Drug Manufacturing Standards

• 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  Agency issued draft guidance on companion diagnostic approval on July 14.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  Agency’s draft guidance should be coupled with HHS’ proposals from last year, which are still being reviewed.
  
• Prospect of Court Appeals and Congressional Bill Hold the Cards for hESC Research
  Case seeks to prevent the use of federal dollars, while Washington’s conservative bent is cause for concern.
  
• 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.
  
• Extent of Feedback on RUO/IUO In Vitro Dx Draft Guidance Means Changes Not Expected Soon
  Industry voiced several complaints during agency’s comment period and provided some evidence of negative consequences.
  
• FDA’s Appeal for Budget Hike Will Have to Succumb to Budget Reality
  The Senate was kinder than the House, but both went well below what the agency appealed for.
  
• FDA Details Requirements for Regulatory Submissions of Genomic Biomarkers
  Agency hopes efforts to streamline biomarker development will advance more into the clinic.
  
• FDA Aims to Bridge Communication Gap with Drug Industry During Reviews Through PDUFA V
  Heavier time investment early on is expected to translate into a faster, more streamlined approval process.
  
• FDA Evaluating Input from Industry on Nanotech Guidance
  Questions and comments covered FDA’s definitions of what constitutes a nanomaterial.
  
• Avastin Label Changes Reignites Debate: Is OS or PFS the Better Regulatory Endpoint?
  A recent panel discussion set the stage for defining standards for drug approval as separate from those for treatment decisions.
  
• 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.
  
• FDA New Drug Approvals in 2011 Outpace Recent Past
  Agency sanctioned 35 new medications including two with companion diagnostics.
  
• What Will FDA Biosimilars Guidelines Mean for Industry?
  Agency hasn’t settled on requirements for interchangeability and exclusivity period for pioneer biologics.
  
• How Provenge Laid the Groundwork for Developing and Regulating Cancer Vaccines
  FDA’s recently issued guidelines pull from more than 20 years of research and clinical experience.
  
• 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.
  
• Surveys Point to Biopharmas Following the Money by Outsourcing More
  CROs are playing a growing role in R&D, and companies are also offshoring clinical trials.
  
• 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.
  
• 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.