Related to Genentech Prepares to Vouch for Avastin’s Use in Breast Cancer in FDA Hearing

• Roche Takes a Stab at Getting mAbs Under the Skin
  Firm is testing Herceptin SC in Phase III and expects to couple it with a user-friendly delivery device.
  
• Antibody-Drug Conjugates to Fight Cancer
  While mAbs have been extremely successful, these empowered antibodies are touted as the next big blockbusters.
  
• Ocrelizumab: One Size Does Not Fit All
  Risk of serious infections has hampered mAb’s development in RA and LE, but drug is still being tested in MS.
  
• Biomarkers Poised for Breakout Moment
  A passel of discussions at BIO highlight the importance of these disease-state indicators.
  
• 2010 in Review: Biotechnology Highlights
  Gene patenting and ESCs were back in the headlines along with breakthroughs in sequencing, syn bio, and other fields.
  
• Reporting from J.P. Morgan on Drug Development Companies
  Even the unseasonal cold couldn’t dampen the spirit of the biotech community.
  
• 2011 Budget Outlook: Trim, Cut, Then Slash
  Agencies like the FDA and NIH are looking at potentially huge cuts.
  
• 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.
  
• Latest Gene Therapy Disapproval Points to Confusion over Regulatory Setup
  Gene therapy developers also need to keep an eye on demonstrating efficacy.
  
• FDA New Drug Approvals in 2011 Outpace Recent Past
  Agency sanctioned 35 new medications including two with companion diagnostics.
  
• 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.
  
• 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.
  
• Firms Are Trying to Untangle Alzheimer Drug Development with mAbs
  AD remains one of few therapeutic areas with blockbluster potential.
  
• 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.
  
• 15 Breast Cancer Drugs in the Pipeline Right Now
  Which candidates are on their way from the lab to the medicine chests of thousands?
  
• Genome Testing Reduces Overtreatment
  Study after study has shown that molecular diagnostics can help oncologists more effectively treat patients.
  
• Cliff Spells Danger for Biotechs
  If Obama and Congress cannot agree, key agencies face cuts while tax changes would dampen new investment.