BioSpace News Archive

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• Pharm Country

  Accelerate NY Seed Fund Awards Bioharmony Therapeutics $100,000 to Develop a Lysin-based Treatment for Skin Infections Caused by Multi-drug Resistant Acinetobacter baumanii

  ANY invested $100,000 in the company’s seed round.

  December 18, 2017

   · 

  4 min read
• Drug Development

  FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

  Trial participant recruitment is now underway and the studies are expected to conclude in early 2019.

  December 18, 2017

   · 

  10 min read
• 

  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
• 

  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
• 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