Related to Cepheid Eyes Two-Week Shipping for Xpert Flu Diagnostic in the U.S.

• 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.
  
• 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.
  
• 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.
  
• FDA New Drug Approvals in 2011 Outpace Recent Past
  Agency sanctioned 35 new medications including two with companion diagnostics.
  
• 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.
  
• 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.
  
• 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.
  
• 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.
  
• This Time Last Year: Diagnostic Deals, mAb Therapeutics, and Obesity Drug Development
  Among big news was Roche’s companion diagnostic alliance with Clovis, a melanoma deal with BMS, and FDA’s Avastin decision.
  
• With USPTO Report Near, Comments Reflect Confirmatory Diagnostic Testing Divide
  Dx makers would like to keep patent protection, but patient groups say it stifles broader access to genetic tests at lower cost.
  
• LAVAgel for Protein Diagnostics
  Researchers introduce a microfluidic, single-channel, multistage immunoblotting strategy toward scalable protein isoform analysis.
  
• Genome Testing Reduces Overtreatment
  Study after study has shown that molecular diagnostics can help oncologists more effectively treat patients.