BioSpace News Archive

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  FDA

  Voluntis’ Insulia Snags FDA Clearance and CE Mark to Integrate Basaglar and Tresiba

  This now makes Insulia available for people using any brand of basal insulin including Lantus, Levemia, Toujeo, Tresiba and Basaglar.

  November 16, 2017

   · 

  3 min read
• Tetra Bio-Pharma: Rx Princeps Now Available for Patients Through Licensed Producer Partner Aphria

  Based on the most recent ACMPR market data from the Government of Canada, it is estimated that the sales of dried medical cannabis in Canada from April 2017 to March 2018 will be over $188M.

  November 16, 2017

   · 

  5 min read
• Business

  Philips and Nuance Team to Bring AI Directly Into Radiology Reporting

  The initiative will leverage assets from Philips Illumeo with adaptive intelligence and Nuance PowerScribe 360 to help reduce discrepancies, and improve radiology reporting, accuracy and standardization.

  November 16, 2017

   · 

  6 min read
• Policy

  FDA Announces Comprehensive Regenerative Medicine Policy Framework

  The framework - outlined in a suite of four guidance documents - builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

  November 16, 2017

   · 

  7 min read
• 

  FDA

  Bay Area’s Nevro Wins MR-Conditional CE Mark for Senza Spinal Cord Stim

  This approval is retroactive, meaning that the new labeling for expanded imaging applies to all patients currently implanted with the Senza SCS System with percutaneous leads.

  November 16, 2017

   · 

  8 min read
• Roche Launches DISCOVERY Teal HRP Chromogen Detection Kit to Advance Tissue-Based Cancer Research

  Roche today announced the launch of the DISCOVERY Teal HRP kit1, the newest addition to the comprehensive collection of modular-based detection kits to identify and profile biomarkers and cell populations in tissue-based research.

  November 16, 2017

   · 

  4 min read
• Pharm Country

  Canon BioMedical Launches Assays for Spinal Muscular Atrophy Research

  The PCR-based method only requires a thermocycler capable of high-resolution melting and a single sample replicate.

  November 16, 2017

   · 

  2 min read
• Business

  CSSB and Leica Microsystems Establish an Advanced Light and Fluorescence Microscopy (ALFM) Facility and Integrated Cryo-Imaging Solutions

  The partnership, being announced to coincide with the Opening Symposium of the CSSB, will see major collaboration between the two parties for the development of new integrated Cryo-Imaging solutions and the establishment of an advanced microscopy facility.

  November 16, 2017

   · 

  2 min read
• Biotech Bay

  PacBio and GENEWIZ Announce Winner of the 2017 AACR SMRT Grant

  With this SMRT Grant, Dr. Ludlow will receive Iso-Seq analysis on the PacBio Sequel System at the GENEWIZ laboratory to further his investigation to understand the splicing of transcripts regulated by NOVA1 in lung cancer cells.

  November 16, 2017

   · 

  3 min read
• BioMidwest

  Titan Spine Announces the First Endoskeleton Interbody Fusion Cases in Australia

  Surgeries open entry into new market and expand global footprint.

  November 16, 2017

   · 

  3 min read