BioSpace News Archive

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• Policy

  Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag NDA With Priority Review

  The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is May 21, 2018.

  November 28, 2017

   · 

  4 min read
• Prima BioMed Becomes Immutep

  The Company is pleased to advise that the name Immutep Limited has been formally adopted after ASIC registration.

  November 28, 2017

   · 

  1 min read
• Drug Development

  AIT Therapeutics Announces Positive Preliminary Data for the Primary Endpoint of Safety in Its NO-NTM Abscessus Phase II Clinical Trial in Nontuberculous Mycobacteria (NTM) Patients

  The safety data, along with positive results in other key parameters, drive AIT’s decision to move the program forward and plan for a potential pivotal trial to begin in the United States in the second half of 2018.

  November 28, 2017

   · 

  8 min read
• Policy

  Aeterna Zentaris’ Marketing Authorization Application for Macrilen (macimorelin) for Evaluation of Adult Growth Hormone Deficiency Accepted by EMA

  AGHD affects approximately 75,000 adults across the US, Canada and Europe.

  November 28, 2017

   · 

  5 min read
• 

  Business

  CIRCULOGENE Names Dr. Glen J. Weiss as CMO

  Dr. Weiss will oversee and advance the laboratory’s research efforts and further educate oncologists about CIRCULOGENE’s next-generation sequencing (NGS) technology.

  November 28, 2017

   · 

  3 min read
• Business

  Ascensia Diabetes Care and Health2Sync Announce Collaboration to Bring Digital Diabetes Management Solution to Patients In Asia

  As part of this collaboration, the companies will create a combined offering for people with diabetes that comprises of the CONTOUR PLUS or CONTOUR TS blood glucose monitoring systems from Ascensia, the Health2Sync app and a loyalty program for users, known as the Ascensia Customer Care Program.

  November 28, 2017

   · 

  3 min read
• Business

  PhaseBio Enters Worldwide License Agreement With MedImmune for a Reversal Agent for Ticagrelor

  Ticagrelor is unique among P2Y12 antagonist antiplatelet agents due to its ability to reversibly bind to the receptor, whereas other P2Y12 antagonists bind permanently.

  November 28, 2017

   · 

  3 min read
• Genetown

  Novanta Chairman of the Board Sells a Portion of His Shares for Estate Planning Purposes

  Novanta announced today that the Company’s Chairman of the Board, Stephen W. Bershad, has sold 500,000 common shares, representing approximately 22% of his holdings in the Company.

  November 28, 2017

   · 

  6 min read
• Seno Medical Instruments’ Imagio Opto-Acoustic Breast Imaging System Demonstrates Ability to Downgrade Risk Classification of Benign Breast Masses in a Prospective European Clinical Trial

  The prospective, controlled, multi-center study was conducted at five centers in the Netherlands between March 2015 and February 2016.

  November 28, 2017

   · 

  5 min read
• Deals

  CanniMed Therapeutics Acts to Protect Shareholders From Aurora Cannabis’ Opportunistic Offer and Enable Fair Vote on Newstrike Acquisition with Shareholder Rights Plan

  The purpose of the Plan is to ensure that all shareholders are fairly treated, well informed and not subject to coercive bids.

  November 28, 2017

   · 

  8 min read