Related to PrognosDx and Accium to Work on Histone Biomarker Cancer Tests

• 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.
  
• 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.
  
• Nanotechnology Enables Precise Cancer Targeting
  While first-generation nanodrugs reduced toxicity, next-gen treatments are being designed to increase efficacy.
  
• What Comes After Dendreon’s Provenge?
  Success of prostate cancer vaccine has ushered in a wave of autologous vaccine development.
  
• Will a Nonautologous Cancer Vaccine Be the Next to Make It Through Approval?
  In the race to mimic Dendreon’s success with Provenge, off-the-shelf products make for attractive opportunities.
  
• Tales from the Biotech Crypt: Sam Waksal Is Back in Business
  Former ImClone CEO has started a new firm, made three acquisitions including Three Rivers, and begun licensing.
  
• Melanoma Cells: All Stem Cells in Disguise?
  Researchers believe that the cancer stem cell theory may not apply to all cancers.
  
• Beckman Coulter on the Chopping Block?
  Some analysts believe it is not a question of who will buy the firm but if the firm will be bought.
  
• What’s Wrong with Phase II Trials?
  A better early-phase clinical plan could address high attrition rates in Phase III.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance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.
  
• 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.
  
• Prometheus and Myriad Case Outcomes Will Help Shape the Future for MDx Businesses
  Courts’ current decisions suggest that special attention will need to be paid to performing and claiming transformative steps in biomarker-based tests.
  
• Does Clinical Success Mean Commercial Success for Cancer Vaccines?
  Getting insurers to pay for immunotherapies and keeping doctors more informed are key to market growth.
  
• Amicus Filings in Prometheus v. Mayo Reflect Divide Over Diagnostic Method Patentability
  Supreme Court has to decide whether to reverse previous stance upholding two of Prometheus’ method patents.
  
• Vaccine Isotype Seems to Affect Clinical Outcome in Blood Cancer Trials
  New results presented at ASH will impact production of autologous immunotherapies.
  
• 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.
  
• USPTO Tasked with Evaluating Impact of Gene Patents on Second-Opinion Testing
  Diagnostic firms argue IP protection is key to innovation, while their opponents say it hurts medical practice.
  
• 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.
  
• Debate over Patenting Genes at Forefront of First Hearing on Second Opinion Testing
  Hearing was part of a study required by the new patent system to assess the impact of gene patents on obtaining confirmatory tests.