BioSpace News Archive

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  FDA

  Spectral’s Proprietary Stand-Alone Pump Wins FDA 510(k) Clearance

  Spectral Medical today announced that the FDA has granted 510(k) clearance for the Spectral Apheresis Machine for use in continuous renal replacement therapy and therapeutic plasma exchange.

  December 18, 2017

   · 

  3 min read
• Biotech Beach

  The Cryoport Biotech Activity Index Decreases 7.1% In Third Quarter of 2017; While the Total Number of Clinical Trials Increases to 934 Worldwide

  The decrease in the CoBRA Index was primarily due to the termination of a Phase III trial and pauses in dosing for several early stage trials.

  December 18, 2017

   · 

  5 min read
• 

  Business

  Neurotrope Poaches Forest Lab Exec to Be CEO

  Dr. Ryan becomes a Director of the Company effective immediately and will assume his responsibilities as CEO effective February 15, 2018.

  December 18, 2017

   · 

  6 min read
• Deals

  Isodiol to Snap Up Biosynthesis Pharma Group

  The BSPG acquisition includes multiple entities that are strategic to the future of Isodiol.

  December 18, 2017

   · 

  5 min read
• Drug Development

  Novartis Multiple Sclerosis Therapy Fingolimod Granted FDA Breakthrough Therapy Designation for Pediatric MS

  The Breakthrough Therapy designation is based on data from the Phase III PARADIGMS study.

  December 18, 2017

   · 

  13 min read
• Drug Development

  Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Leber’s Hereditary Optic Neuropathy

  Top-line results from the study are expected by mid-2018.

  December 18, 2017

   · 

  3 min read
• Policy

  60° Pharma Submits NDA to U.S. FDA for Antimalarial Drug Tafenoquine

  60 Degrees Pharma as submitted a NDA to the FDA for the use of Tafenoquine to prevent malaria in adults traveling to areas where malaria is prevalent.

  December 18, 2017

   · 

  4 min read
• Pharm Country

  Impulse Dynamics’ Optimizer Receives CFDA Approval in China

  The CFDA has approved Impulse Dynamics’ Optimizer system for treatment of chronic heart failure.

  December 18, 2017

   · 

  2 min read
• Genetown

  PAREXEL Announces Enhanced Global Data Operations Offering to Drive Efficiencies for Life Science Companies

  PAREXEL today introduced its enhanced GDO solution, with augmented processes and expertise that further bolsters its world leading clinical data services, including data management, statistical programming and biostatistics.

  December 18, 2017

   · 

  4 min read
• Genetown

  Cambridge BioMarketing Discusses Outlook for Gene Therapy and CAR-T Treatments in 2018

  In 2017 we saw landmark breakthroughs in advanced genetic therapies, such as viral mediated gene transfer and CAR-T therapies.

  December 18, 2017

   · 

  4 min read