BioSpace News Archive

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• Policy

  ContraVir Pharmaceuticals Reaches Agreement with the FDA on the NDA Package for TXL™ Leveraging the 505(b)(2) Regulatory Pathway

  On January 8, 2018, the ContraVir Executive Team met with the FDA’s Division of Antiviral Products at the Center for Drug Evaluation and Research, to review and discuss the data generated for TXL.

  February 12, 2018

   · 

  4 min read
• Business

  Genetic Technologies Limited: Update on Strategic Alliance

  GTG will provide a market update as soon as it is able to conclude that review by the ASX.

  February 12, 2018

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  2 min read
• Business

  Herantis Pharma Strengthens Team - Outi Lahdenperä and Antti Vuolanto Have Joined Herantis

  The company has strengthened its core team with two experienced drug development professionals.

  February 12, 2018

   · 

  3 min read
• Business

  Bovie Medical Corporation to Release Fourth Quarter and Fiscal Year 2017 Financial Results on March 12, 2018

  Management will host a conference call at 4:30 p.m. Eastern Time on March 12 to discuss the results of the quarter and fiscal year and to host a question and answer session.

  February 12, 2018

   · 

  2 min read
• Genetown

  New CRA Survey Shows Optimistic Attitude Towards eSource

  Using the CRIO system, investigators can configure templates and collect source data electronically.

  February 12, 2018

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  3 min read
• Business

  ASIT Biotech 2017 Annual Results: Ongoing ASIT+ Products Development in Respiratory and Food Allergies

  ASIT Biotech today announces its annual results for the year 2017, prepared in accordance with the IFRS standards adopted by the European Union, as well as its recent clinical developments and 2018 outlook.

  February 12, 2018

   · 

  2 min read
• Biotech Beach

  Family of Beverly and Ben Horowitz Creates Fund at City of Hope to Advance Innovative CAR T Cell Therapy Research

  In memory of Ben and Beverly Horowitz, longtime chief executive officer and first lady of City of Hope, their family has donated $1 million to City of Hope to help advance groundbreaking CAR T cell immunotherapy research to combat cancer.

  February 12, 2018

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  7 min read
• Drug Development

  Audentes Therapeutics Announces Dosing of First Patient in VALENS, a Phase I/II Clinical Trial of AT342 for the Treatment of Crigler-Najjar Syndrome

  In addition to VALENS, the clinical development program for AT342 includes LUSTRO, a prospective natural history run-in study in Crigler-Najjar patients.

  February 12, 2018

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  7 min read
• Policy

  U.S., EU and Japan Health Authorities Accept Regulatory Submissions for Review of Pfizer’s Third-Generation ALK Inhibitor Lorlatinib

  Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib.

  February 12, 2018

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  9 min read
• Business

  Saama Partners With Informa Pharma Intelligence’s Citeline to Bridge Clinical Trial Information to Real World Evidence for Unprecedented Customer Experience

  Saama Technologies, Inc., a leading clinical analytics company, and Citeline, Inc., part of Informa Pharma Intelligence’s suite of pharmaceutical and biomedical research and analysis solutions, unveiled a strategic partnership today that will disrupt and advance the existing clinical trial landscape.

  February 12, 2018

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  4 min read