Related to FDA Clears Beckman Coulter’s phi Blood Test for Prostate Cancer

• What Will FDA Biosimilars Guidelines Mean for Industry?
  Agency hasn’t settled on requirements for interchangeability and exclusivity period for pioneer biologics.
  
• 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.
  
• 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.
  
• Fewer Approvals and Filings Sully FDA Offensive
  Agency’s recent efforts to shake off industry criticism are not supported by the numbers.
  
• Obesity Drug Developers Post Steady Gains
  High clinical trial costs and slower FDA approvals are among the hurdles to obesity drug approval.
  
• Meningitis Outbreak Prompts Policy Review
  Compounding pharmacies anticipate new rules following the meningitis outbreak, including an answer to the longstanding question of federal vs. state oversight.
  
• FSD Drugs Advance as Women Push for Equal Access
  Drug development in this arena has proven difficult, but some successes have been reported recently.
  
• Genome Testing Reduces Overtreatment
  Study after study has shown that molecular diagnostics can help oncologists more effectively treat patients.
  
• With GAIN, Less Pain
  Antibiotic drug developers welcome incentives, though cost, rules remain a challenge.
  
• Getting FDA to Yes
  As PDUFA, patent cliff drive 2012 approvals, can industry keep cranking out new molecules?
  
• 10 Predictions That Will Transform Healthcare
  Peer into GEN's crystal ball for a glimpse of what's to come.
  
• Transgenic Salmon Prove Tough to Tackle
  Many salvos have been fired to prevent the introduction of genetically engineered fish into commercial aquaculture.
  
• Detecting Acquired Drug Resistance in Cancer
  New methods allow noninvasive analysis in blood plasma.
  
• Moving Genomics Closer to the Clinic
  Foundation Medicine and Memorial Sloan-Kettering Cancer Center are working to translate genomic information into personalized cancer treatment.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• 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.
  
• 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.
  
• Getting Cancer Immunotherapeutics Approved
  It’s not just the FDA standing in the way.
  
• 7 Biotech Trends for the Coming Year
  What does 2013 hold for the industry?