Industry News

• NuVasive announces UK launch Of MAGEC® X for early onset scoliosis treatment  NuVasive announced the U.K. launch of MAGEC® X, the newest product generation within the MAGEC pediatric portfolio that addresses early-onset scoliosis. The development of MAGEC X is distinguished by the inclusion of 5.0mm diameter patient rods, delivering a 68 percent improved fatigue-strength.
  September 18, 2018  
• AmpliPhi Biosciences announces positive FDA feedback for its clinical stage bacteriophage   AmpliPhi Biosciences announced the company has received positive feedback, via written response, from the FDA regarding its development plans for AB-PA01, without the need for a Type B Pre-IND meeting. No additional clinical or nonclinical data are required to proceed with the proposed trials.
  September 18, 2018  
• Hemispherx to distribute second lot of Ampligen® for use in multiple indications  Hemispher announced regulatory inspection and clearance for distribution of the Company's second commercial scale lot of Ampligen® (rintatolimod), which is slated for multiple uses including product launch in Argentina, the U.S. and Europe.
  September 18, 2018  
• Bio-Techne announces publication of data demonstrating clinical validation of its EPI test  Bio-Techne announced the online publication of its second prospective US clinical validation study of the Exosome Diagnostics-branded ExoDx® Prostate(IntelliScore) in European Urology [McKiernan J, et al. ExoDx® is the first exosomal urine-based liquid biopsy test.
  September 18, 2018  
• CRISPR Therapeutics and ViaCyte announce strategic collaboration for diabetes  CRISPR Therapeutics and ViaCyte announced a collaboration focused on discovery, development, and commercialization of gene-edited allogeneic stem cell therapies for treatment of diabetes. ViaCyte will receive $15 million from CRISPR, which may be paid in either cash or CRISPR stock.
  September 18, 2018  
• LivaNova launches international pivotal study evaluating autonomic regulation therapy  LivaNova announced the first successful implantation of the VITARIA® System in a patient enrolled in the Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction Pivotal Study.
  September 18, 2018  
• Experimental nasal influenza vaccine tested in kids, teens  An early-stage clinical trial testing the safety and immune-stimulating ability of an experimental nasal influenza vaccine in healthy 9- to 17-year-old children and teens has begun enrolling participants at an NIAID-supported VTEU site at Saint Louis University, St. Louis, Missouri.
  September 18, 2018  
• Medtronic announces clinical study of transcatheter aortic valve replacement  Medtronic announced the FDA has approved an investigational device exemption to initiate a single-arm study to evaluate the CoreValve Evolut(TM)TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality.
  September 18, 2018  
• Kraig Biocraft Laboratories accelerates development of new recombinant Spider Silk Fibers  Kraig Biocraft Laboratories announces that it has implemented two major advancements in the development of next generation recombinant spider silk fibers. The Company expects to see higher throughput as this approach should result in shorter times to generate new transgenics.
  September 18, 2018  
• PharmaCyte successfully completes final pre-production run of pancreatic cancer product  PharmaCyte Biotech announced that its partner, Austrianova, has successfully performed an additional pre-production “engineering run” using the Cell-in-a-Box® encapsulated cells that will be used, in combination with low doses of the cancer prodrug ifosfamide, for treatment of LAPC.
  September 18, 2018  

   (next 10 articles)