Related to Exonhit Joins €6M EU Consortium to Develop Tests for Predicting Avastin, Herceptin Response

• Tumor Cells Back in Circulation for Monitoring Cancer
  With one test on the market, researchers are developing tools that leverage CTCs as biomarkers.
  
• 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.
  
• NIH Updates Its Strategy to Combat Obesity
  Research spending has been on the upswing, but so has the obesity epidemic.
  
• Academic Organizations Try to Step Up Their R&D Game
  Sector has work cut out for it as ARRA has dried up and gov’t as well as industry cut budgets.
  
• 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• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• Revival of Tax Credit Program Depends on Job Creation and Scientific Results
  Members of Congress are trying to expand the Qualified Therapeutic Discovery Program through 2017.
  
• 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  Agency issued draft guidance on companion diagnostic approval on July 14.
  
• Companies with Cancer Therapeutic Candidates Ramp Up Companion Diagnostic Efforts
  As regulatory framework gets fine-tuned, firms realize the importance of having a biomarker strategy.
  
• 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.
  
• 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.
  
• Standardization Key to Taking Next-Generation Sequencing to the Next Level
  As NGS technology makes steady progress with faster and cheaper machines, regulation will have to keep up.
  
• NIH Taps 25 Schools to Receive Top Dollars
  Did your alma mater make the list?
  
• SBIR Thinks Smaller
  New rules taking effect on January 28 aim to draw investor-owned smaller biopharmas to the federal grant program and STTR, its companion.
  
• Funding Squeeze Traps Young Researchers
  Postdocs look beyond NIH funding as, despite policy changes, the percentage and age of first-time grant winners stay steady.
  
• 20 Grants for Young Researchers
  Looking for funding? Here are some places to start.
  
• Companion Diagnostics: 52 Pick-Up
  Check out our three lists of 52 CDx: those approved by the FDA, those under review right now, and those that may be coming soon.
  
• GEN Hall of Shame
  Meet the Congressional enemies of research funding.
  
• Avastin: Time for a Predictive Test
  Roche’s strategy to expand the use of Avastin into the first-line and adjuvant settings is particularly dependent on identifying those most likely to see a benefit.
  
• This Time Last Year: Diagnostic Deals, mAb Therapeutics, and Obesity Drug Development
  Among big news was Roche’s companion diagnostic alliance with Clovis, a melanoma deal with BMS, and FDA’s Avastin decision.