Related to Proteome Sciences and Buck Institute Ally on MS-Based Anti-Estrogen Therapy Resistance Assays

• Is Avastin Roche’s Achilles Heel?
  Label-expansion efforts have failed, and mAb stands to lose provisional approval in breast cancer.
  
• 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.
  
• To Battle Super-Bugs, Antibiotic R&D Needs to Be Re-Incentivized
  Regulatory constraints and lower ROI have been impeding investment.
  
• Exploring New Ways to Get at Old Bacterial Targets to Combat Resistant Strains
  Arsenal must include not just souped-up me toos but also some brand new compounds.
  
• Biotechnology Instruments Being Used to Detect Alien Life
  Researchers are building devices based on molecular biology techniques like PCR and MS.
  
• 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.
  
• 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  Agency issued draft guidance on companion diagnostic approval on July 14.
  
• 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.
  
• Secrecy Surrounds the Development of Tests to Detect Doping
  Therapeutic firms stress the need for a proactive approach against athletes who misuse drugs.
  
• 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.
  
• 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.
  
• 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.
  
• A Little Mass Spec Goes a Long Way
  Review of a new method for the discovery of catalytic reactions shows its importance for also finding more optimal catalysts.
  
• 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.
  
• Enzo Sues Roche, Gen-Probe, and Life Technologies in Patent Infringement Case
  Patent under dispute expires in 2023, and defendants plan on fighting the lawsuit.
  
• Myriad, Prometheus Continue to Defend Diagnostic Patents while Others Urge More Licensing
  Battle raged on at second USPTO hearing tasked with evaluating the impact of patents on the availability of confirmatory tests.
  
• 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.
  
• Lawyers Offer Predictions for Myriad, Diagnostic Field Based on Supreme Court’s Decision Against Prometheus
  Advice focuses on ensuring transformative steps are included in claims.
  
• Flow Cytometry Goes Atomic
  Single-cell “mass cytometry” approach shows ability to measure a greater number of parameters simultaneously.