BioSpace News Archive

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• FDA

  AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

  FDA requires extended time for review of additional information in New Drug Application (NDA)

  April 10, 2018

   · 

  6 min read
• Drug Development

  Kadmon Receives FDA Guidance on Pivotal Clinical Trial Design for KD025 in Chronic Graft-Versus-Host Disease

  Based on the FDA’s guidance, Kadmon plans to initiate an open-label, two-arm, pivotal Phase 2 clinical trial to support the potential registration of KD025 in cGVHD.

  April 10, 2018

   · 

  5 min read
• Deals

  Nutriband Inc. Acquires 4P Therapeutics Inc.

  4P Therapeutics will now become the Pharmaceutical and Development arm of Nutriband Inc.

  April 10, 2018

   · 

  5 min read
• Business

  Phynd announces partnership with Healthwise

  Phynd’s intelligent Provider Information Management™ solution now fully integrated with Healthwise’s robust clinical taxonomy

  April 10, 2018

   · 

  2 min read
• Business

  Gustave Roussy and Protagen AG Collaborate to Improve the Risk Profiling of Cancer Patients Undergoing Immunotherapy

  Protagen AG and Gustave Roussy have today announced the start of a collaboration to utilize Protagen’s SeroTag® technology to help identify biomarkers that predict and monitor immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitors.

  April 10, 2018

   · 

  3 min read
• Biotech Bay

  ReShape Lifesciences Pioneers New Bio-electronic Technology for Treatment of Type 2 Diabetes

  Results Showing Improved Glycemic Control with ReShape Lifesciences Neuromodulation in an Obese Rat Model to be Presented at Industry Conference

  April 10, 2018

   · 

  5 min read
• Business

  Pfizer Joins the TriNetX Global Health Research Network Formed to Improve Clinical Trial Design and Accelerate the Development of New Drugs

  Pfizer will have access to clinical data from TriNetX’s network of healthcare organizations to support clinical study and protocol design, site identification, and patient recruitment for clinical trials across a range of therapeutic areas and development stages.

  April 10, 2018

   · 

  3 min read
• Business

  Haemonetics Sets Date for Publishing Fourth Quarter Fiscal 2018 Results: May 8, 2018

  Haemonetics Corporation (NYSE:HAE) announced that the Company intends to publish fourth quarter fiscal 2018 financial results at 6:00 am EST on Tuesday, May 8, 2018

  April 10, 2018

   · 

  1 min read
• Propanc Biopharma Completes Scientific Advice Meeting with MHRA

  Company Receives Guidance on the Investigational Medicinal Product Manufacturing Program for PRP.

  April 10, 2018

   · 

  4 min read
• Business

  CENTOGENE Expands Executive Team, Appoints Dr. Dirk Ehlers Chief Operating Officer

  CENTOGENE announced the appointment of Dr. Dirk Ehlers as Chief Operating Officer (COO) and President of the Diagnostics Division.

  April 10, 2018

   · 

  2 min read