Related to EMA’s Draft Rules for Interferon Beta Biosimilars Include Clinical and Nonclinical Studies

• FDA Outlines Strategic Priorities but Action Is Further Out
  The agency will take at least another year to flesh out plans.
  
• FDA Tries to Address Some Concerns Over Nanotech in Biotech
  More details are needed, but developers now have a better idea of what constitutes nanomaterials.
  
• 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• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• 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  Agency issued draft guidance on companion diagnostic approval on July 14.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  Agency’s draft guidance should be coupled with HHS’ proposals from last year, which are still being reviewed.
  
• 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.
  
• FDA Offers Clues to How It Will Pave the Way to Getting Biosimilars on the Market
  Paper in NEJM divulged the broad strokes of agency’s plans, but nuts and bolts are still up in the air.
  
• Extent of Feedback on RUO/IUO In Vitro Dx Draft Guidance Means Changes Not Expected Soon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 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.
  
• Latest Gene Therapy Disapproval Points to Confusion over Regulatory Setup
  Gene therapy developers also need to keep an eye on demonstrating efficacy.
  
• 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.
  
• Firms Are Upping the Stakes on mAb Biosimilar Development
  As originators try to defend their patents, companies make larger investments in biosimilars.
  
• 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.
  
• Fewer Approvals and Filings Sully FDA Offensive
  Agency’s recent efforts to shake off industry criticism are not supported by the numbers.