BioSpace News Archive

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• Drug Development

  Evoke Pharma Announces Positive Topline Results from Comparative Exposure Pharmacokinetic Study for Gimoti

  505(b)(2) NDA on track for FDA submission in Q1 2018.

  October 23, 2017

   · 

  6 min read
• Kyomed Nominated For A 2017 Galien MedStartUp Award

  Kyomed announces its selection, in conjunction with project leader Neogia and project partner Bluesleep clinic, as a finalist in the 2017 MedStartup awards.

  October 23, 2017

   · 

  3 min read
• Drug Development

  Reata Announces First Patient Enrolled in Part II of MOXIe Study of Omaveloxolone for the Treatment of Friedreich’s Ataxia

  The trial will enroll approximately 100 FA patients randomized evenly to either 150 mg of omaveloxolone or placebo.

  October 23, 2017

   · 

  4 min read
• Business

  Rapid Micro Biosystems Awarded a Contract by Biomedical Advanced Research and Development Authority (BARDA) for the Implementation of a Rapid Sterility Test for Vaccines

  This awarded grant is part of BARDA’s Advance Development of Medical Countermeasures for Pandemic Influenza, which focuses on improving the government’s responsiveness to future pandemic threats.

  October 23, 2017

   · 

  2 min read
• Policy

  MannKind and BIOMM Submit Registration Dossier to Brazilian Health Regulatory Agency (ANVISA)

  Afrezza is the only inhaled rapid-acting mealtime insulin approved by the U.S. Food & Drug Administration.

  October 23, 2017

   · 

  4 min read
• Business

  Queen’s University Belfast in Collaboration with Almac Group Lead Largest Study of its Kind to Transform Prostate Cancer Treatment

  Queen’s University Belfast have led the world’s largest research study using a diagnostic test developed by Almac Diagnostics, to better understand the biology of prostate cancer tumours.

  October 23, 2017

   · 

  4 min read
• Cesar Millan helps Avivagen Relaunch Vivamune Health Chews in U.S.

  At the heart of Vivamune is an active substance, called OxC-beta (OxC-beta) compound, Avivagen’s proprietary formulation of fully oxidized β-carotene.

  October 23, 2017

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  6 min read
• Business

  Recipharm Equips Lisbon Facility for US and European Serialisation

  Recipharm, a leading contract development and manufacturing organisation (CDMO) has equipped its sixth facility with serialisation capabilities ahead of the US and European regulation enforcement deadlines.

  October 23, 2017

   · 

  3 min read
• Biotech Bay

  Soleno Therapeutics Regains Compliance With NASDAQ Listing Requirements

  Soleno is in compliance with all applicable listing standards and its common stock will continue to be listed on The NASDAQ Capital Market and NASDAQ considers the matter closed.

  October 23, 2017

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  2 min read
• Business

  Pixium Vision Establishes an Equity Line Financing With Kepler Cheuvreux

  Pixium Vision announces the implementation of an equity line financing facility with Kepler Cheuvreux.

  October 23, 2017

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  4 min read