BioSpace News Archive

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• Drug Development

  Ra Pharmaceuticals Initiates Dosing in Phase II Clinical Trial Evaluating RA101495 SC in Generalized Myasthenia Gravis Patients

  Ra Pharmaceuticals announced that it has initiated dosing in the Company’s Phase 2 clinical trial evaluating RA101495 SC for the treatment of generalized myasthenia gravis (gMG).

  December 21, 2017

   · 

  6 min read
• Drug Development

  Moleculin Announces Polish Approval for Leukemia Clinical Trial

  Moleculin Biotech announced that the Ethics Committee in Poland has approved the Company’s Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory AML.

  December 21, 2017

   · 

  3 min read
• Drug Development

  BioArctic, a Company in Karolinska Development’s Portfolio, Announces That the Phase IIb Study of BAN2401 in Early Alzheimer’s Disease Continues Toward 18-Month Endpoint

  Karolinska Development announces today that BioArctic’s drug candidate BAN2401 did not meet the criteria for success at a 12-month interim analysis of a Phase IIb study in patients with early Alzheimer’s Disease.

  December 21, 2017

   · 

  1 min read
• 

  FDA

  Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia 2 Instrument for Use with Sofia Strep A+ Assay

  Quidel announced today it has received 510(k) clearance and CLIA waiver from the FDA for its Sofia Strep A+ FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of infections by Group A Streptococcus bacteria.

  December 21, 2017

   · 

  8 min read
• FDA

  QView Medical Inc. Announces FDA PMA Approval for QVCAD for the GE Invenia™ 3D Automated Breast Ultrasound System (“ABUS”)

  QView Medical is pleased to announce FDA approval for QVCAD to be used with the GE Invenia™ ABUS in breast screening for asymptomatic dense breasted women whose mammogram was negative.

  December 21, 2017

   · 

  4 min read
• Business

  Aetna Joins SAFE-BioPharma Association

  It is the first health care benefits company to join the association.

  December 21, 2017

   · 

  2 min read
• 

  FDA

  Beckman Coulter Diagnostics Gets FDA Clearance For The Automated Access AMH Immunoassay

  Beckman Coulter announced FDA clearance of its automated Access AMH immunoassay for IVD use in the U.S.

  December 21, 2017

   · 

  3 min read
• BioMidwest

  Monsanto Announces Significant Progress on Commitments in 2017 Sustainability Report

  Monsanto has set a target of improving irrigation water efficiency of global seed production by 25% by 2020 and is more than half way to that goal.

  December 21, 2017

   · 

  4 min read
• Drug Development

  Gemphire Therapeutics Announces Initiation of its First NASH Proof-of-Concept Clinical Trial and its Differentiated NASH Program

  The program is beginning with a Phase 2a proof-of-conceptclinical trial in adults with FPL.

  December 21, 2017

   · 

  11 min read
• Drug Development

  Motif Bio REVIVE-1 Phase III Study Results with Iclaprim Published in Peer-reviewed Journal, Clinical Infectious Diseases

  The positive topline results from this study were announced in April 2017.

  December 21, 2017

   · 

  9 min read