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

• Cliff Spells Danger for Biotechs
  If Obama and Congress cannot agree, key agencies face cuts while tax changes would dampen new investment.
  
• Building a Self-Destructive Mosquito
  Genetically modified mosquitos could be a way to curb the spread of dengue fever in Florida.
  
• 10 Predictions That Will Transform Healthcare
  Peer into GEN's crystal ball for a glimpse of what's to come.
  
• Not Quite 1918, but Flu Still Deadly
  Authorities and manufacturers look ahead to new vaccines and immunization efforts while scrambling to deal with spot shortages.
  
• Biosimilars: Not So Far So Fast
  Regulatory issues are among the hurdles that are slowing down biosimilar production.
  
• Detecting Acquired Drug Resistance in Cancer
  New methods allow noninvasive analysis in blood plasma.
  
• Your Genes, Your Choice?
  Critics say the American College of Medical Genetics and Genomics’ recent recommendations for reporting incidental clinical sequencing results undermine patient autonomy.
  
• Moving Genomics Closer to the Clinic
  Foundation Medicine and Memorial Sloan-Kettering Cancer Center are working to translate genomic information into personalized cancer treatment.
  
• Osiris’ Race to Market an FDA-Approved Stem Cell Product
  Mesenchymal stem cell therapy Prochymal is in Phase III but still has challenges to overcome.
  
• Changes Brewing at the FDA for Orphan Drugs
  Initiatives to de-risk drug development could include redesigning clinical trial requirements.
  
• FDA Panel Hearing Suggests Medical Professionals May Play Role in Direct-to-Consumer Testing
  Changes including more regulation may take some time, as recommendations for the agency are yet to be finalized.
  
• NIH and FDA Taking Partnership for Regulatory and Translational Science One Step at a Time
  Over the past year, initiative named members, held two meetings, and gave out $9.4 million.
  
• 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.
  
• 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.
  
• 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.