BioSpace News Archive

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• FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Cannabidiol (CBD) Oral Solution as Investigational Treatment for Prader-Willi Syndrome

  Prader-Willi syndrome is the most common known genetic cause of life-threatening obesity in children.

  December 27, 2017

   · 

  3 min read
• Biotech Beach

  Organovo Receives Orphan Designation From U.S. FDA for 3D Bioprinted Therapeutic Liver Tissue Treatment of Alpha-1 Antitrypsin Deficiency

  Organovo is now qualified to receive significant benefits throughout its orphan drug development program including more frequent FDA interactions, protocol assistance, and tax credits for clinical research costs.

  December 27, 2017

   · 

  4 min read
• BioCapital

  India Globalization Capital to use Blockchain to Address Issues Specific to the Medical Cannabis Industry

  According to a recent study that was published in JAMA and detailed on www.pennmedicine.org, nearly 70% of all cannabidiol products sold online are either over or under labeled.

  December 27, 2017

   · 

  2 min read
• Policy

  Endonovo Therapeutics Acquires Assets of Electroceuticals Developer, Rio Grande Neurosciences, and Settles Lawsuit

  Under the terms of the settlement agreement, RGN paid $150,000 to Endonovo Therapeutics and granted an exclusive option to Endonovo to acquire the PEMF assets of RGN for $4.5 million.

  December 27, 2017

   · 

  6 min read
• Biotech Bay

  Amarantus Subsidiary MANF Therapeutics Announces Retinal Patent Issuances in Europe Covering MANF & CDNF and Positive Data for MANF in Glaucoma

  The patents extend exclusivity for the use of MANF and CDNF in the treatment of retinal disorders in Europe into 2031.

  December 27, 2017

   · 

  6 min read
• Business

  OneBlood Awards Medline New Distribution Agreement

  Medline announced it has been awarded a distribution agreement with OneBlood, a not-for-profit blood center serving Florida, Georgia, Alabama and South Carolina.

  December 27, 2017

   · 

  1 min read
• Policy

  FDA Grants Orphan Drug Designation to Aptose Biosciences for CG’806 in Acute Myeloid Leukemia

  Orphan drug designation provides Aptose certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

  December 27, 2017

   · 

  5 min read
• Drug Development

  Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation

  Agios has requested priority review for the application, which, if granted, could result in a six-month review process.

  December 27, 2017

   · 

  5 min read
• Business

  Arrowhead Pharmaceuticals Appoints William Waddill to Board of Directors

  Arrowhead announced that the board of directors elected veteran biotechnology executive William Waddill as an independent director of the company, with a term beginning effective January 1, 2018.

  December 27, 2017

   · 

  3 min read
• Lone Star Bio

  SpinalCyte, LLC Announces 25th Patent

  The company has received confirmation of the issuance of European Patent No. 2776556, “Fibroblasts For Treatment Of Degenerative Disc Disease.”

  December 27, 2017

   · 

  1 min read