BioSpace News Archive

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• Policy

  FDA Slaps Warning on Bay Area’s Hand Biomechanics Lab for Failing to Disclose Serious Injury

  The firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.

  December 6, 2017

   · 

  1 min read
• 

  Policy

  Abbott Maintains Nanostim Leadless Pacemaker Halt on Docking Button Issue

  The 3.6mm docking button is designed to allow the Nanostim device to be retrieved after implantation.

  December 6, 2017

   · 

  1 min read
• Drug Development

  ASIT Biotech Significantly Moves Forward in the Preparation of the Clinical Development Plan of gp-ASIT+ in the U.S.

  ASIT biotech has received positive feedback from the FDA on the preparation of the clinical development plan for gp-ASIT+ in the U.S., with only a few comments and the request for some clarification on the Master File.

  December 6, 2017

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  5 min read
• 

  Business

  What You Need to Know About Fibrocor Therapeutics

  Based in Toronto, Ontario, Fibrocor Therapeutics was launched in January 2017.

  December 6, 2017

   · 

  5 min read

   · 

  Mark Terry
• Policy

  Medtronic Partner Mazor Robotics’ CEO Under Investigation for Insider Trading

  The investigation dates back to a probe launched in May by Israel’s version of the U.S. SEC though the subject matter of the investigation was not initially revealed.

  December 6, 2017

   · 

  1 min read
• 

  Business

  SoCal’s Avanir Axes 11% of Workforce

  Avanir Pharmaceuticals will lay off 11 percent of its workforce by the end of January 2018 as part of a company restructuring.

  December 6, 2017

   · 

  2 min read

   · 

  Alex Keown
• 

  Business

  What You Need to Know About DMD Therapeutics

  DMD Therapeutics is based in Seattle, although at present it is a virtual company, and, as its name suggests, is focused on developing therapeutics for DMD.

  December 6, 2017

   · 

  3 min read

   · 

  Mark Terry
• 

  Business

  What You Need to Know About Fortis Therapeutics

  Fortis Therapeutics is focused on immuno-oncology, specifically on developing an ADC for multiple myeloma and late-stage prostate cancer, including both the adenocarcinoma and neuroendocrine types.

  December 6, 2017

   · 

  3 min read

   · 

  Mark Terry
• Business

  Vernalis and Servier Achieve Research Milestone

  Vernalis will receive a payment of EUR 1.0m from Servier in recognition of this achievement.

  December 6, 2017

   · 

  5 min read
• Business

  Proteros biostructures GmbH Names Dave Lemus as New Executive Board Member

  Previous to his appointment, Mr. Lemus was COO and CFO of Medigene AG, assisting in its transformation into an immunotherapy-based company through the establishment of strategic partnerships.

  December 6, 2017

   · 

  2 min read