BioSpace News Archive

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• Genetown

  Anthera Pharmaceuticals Announces Receipt of Nasdaq Listing Determination Notice and Plans Appeal

  Anthera plans to appeal the Staff’s determination and intends to timely request a hearing.

  November 20, 2017

   · 

  2 min read
• Business

  Mdxhealth Teams Up With Pharmaceutical Company Ferrer for Distribution of Its Prostate Cancer Test Selectmdx in Spain

  MDxHealth’s molecular test offers a non-invasive cost saving ‘liquid biopsy’ method to assess a man’s risk for aggressive prostate cancer on the basis of two biomarkers in their urine.

  November 20, 2017

   · 

  5 min read
• Biotech Bay

  CareDx: CMS Releases 2018 Clinical Laboratory Fee Schedule

  This confirms that the AlloMap reimbursement rate will be increased to $3,240.

  November 20, 2017

   · 

  2 min read
• Business

  BiondVax and NIH Sign Clinical Trial Agreement for a Phase II Trial in the U.S. with BiondVax’s Universal Flu Vaccine

  The study designed to evaluate the cell mediated immunity directly induced by BiondVax’s universal flu vaccine candidate M-001, as well as M-001’s priming effect to enhance the immunogenicity of current seasonal influenza vaccines.

  November 20, 2017

   · 

  4 min read
• Policy

  Orexo’s Zubsolv Receives Authorization for Treatment of Opioid Dependence in Europe

  Orexo today announce that the EMA has granted a MA for Zubsolv (buprenorphine and naloxone).

  November 20, 2017

   · 

  3 min read
• Drug Development

  Surrogate Marker and Design of Calliditas Therapeutics’ IgA Nephropathy Phase III Study Agreed With the FDA

  Calliditas Therapeutics announced today that the FDA has accepted its Phase III study design for its lead candidate Nefecon based on proteinuria as endpoint for accelerated approval.

  November 20, 2017

   · 

  4 min read
• Business

  Science Exchange Announces Outsourced R&D Partnership With Alector

  Alector is the latest R&D company to choose to partner with Science Exchange.

  November 20, 2017

   · 

  3 min read
• Policy

  ISCT Announces Support for FDA Regenerative Medicine Policy Framework

  The ISCT today announces its reaction to the release of the FDA’s newly released comprehensive Regenerative Medicine Policy Framework.

  November 20, 2017

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  4 min read
• Biotech Bay

  Biodesy Delta System Enables Researchers to Discover Novel Mechanism Involved in Infectious Disease

  The collaborative study was led by Theodore Jardetzky, PhD, Professor of Structural Biology at Stanford University and involved researchers at Stanford University and Northwestern University.

  November 20, 2017

   · 

  3 min read
• 

  Business

  Acasti Catapults on $133M Deal With Unnamed Leading China-Based Pharma

  If a definitive agreement is reached and signed, the term sheet contemplates that Acasti would receive an upfront payment of $8M upon signing, plus potential additional regulatory and commercial milestone payments in excess of $125M, and tiered double-digit royalties on net sales.

  November 20, 2017

   · 

  4 min read