Related to Measurement of Residual Host Cell Protein and DNA in Biotechnology Products

• 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.
  
• 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.
  
• Comments Sent to FDA on Its Draft Biosimilars Guidance Mostly Conveyed Discontent
  More rigorous testing to prove biosimilarity and safety were the biggest concerns.
  
• 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.
  
• 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.
  
• CMOs Capitalizing on Experience to Develop Their Own Therapeutics
  A few pioneering contract manufacturing organizations are testing the drug development waters.
  
• 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.
  
• Getting Cancer Immunotherapeutics Approved
  It’s not just the FDA standing in the way.
  
• FSD Drugs Advance as Women Push for Equal Access
  Drug development in this arena has proven difficult, but some successes have been reported recently.
  
• With GAIN, Less Pain
  Antibiotic drug developers welcome incentives, though cost, rules remain a challenge.
  
• 7 Biotech Trends for the Coming Year
  What does 2013 hold for the industry?
  
• Building a Self-Destructive Mosquito
  Genetically modified mosquitos could be a way to curb the spread of dengue fever in Florida.
  
• Getting FDA to Yes
  As PDUFA, patent cliff drive 2012 approvals, can industry keep cranking out new molecules?
  
• Transgenic Salmon Prove Tough to Tackle
  Many salvos have been fired to prevent the introduction of genetically engineered fish into commercial aquaculture.
  
• Biosimilars: Not So Far So Fast
  Regulatory issues are among the hurdles that are slowing down biosimilar production.