BioSpace News Archive

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  Biotech Beach

  Glaukos to Begin Randomized U.S. IDE Pivotal Clinical Trial for the iStent SA System

  Glaukos announced that the FDA is allowing the company to move forward with a U.S. IDE pivotal study of its iStent SA Trabecular Micro-Bypass System.

  December 19, 2017

   · 

  7 min read
• Drug Development

  Critical Outcome Technologies Announces Pharmacodynamic Data and Positive Signals of Efficacy from Phase I Dose Escalation Portion of COTI-2 Trial in Gynecological Malignancies

  Critical Outcome Technologies announced pharmacodynamic (PD) data and positive signals of efficacy from the dose-escalation portion of its Phase 1 trial of COTI-2 in gynecological malignancies that support the continued development of COTI-2 as a potential treatment for patients.

  December 19, 2017

   · 

  8 min read
• Business

  ClearPath Development Company Launches Third Collaboration Under Strategic Partnership With Astellas Pharma to Develop Staphylococcus Aureus Vaccine With Boston Children’s Hospital

  ClearPath announced today it has initiated a third research collaboration with Astellas Pharma to combat infections.

  December 19, 2017

   · 

  4 min read
• Deals

  BiomX Acquires RondinX to Boost Microbiome Discovery and Development Capabilities

  The acquisition fortifies BiomX’s bacterial target discovery capabilities and supports its product development pipeline.

  December 19, 2017

   · 

  2 min read
• Policy

  TSO3 Provides Duodenoscope Filing Update

  The Company now believes that the information it has provided to the Regulators addresses the majority of items listed within the initial AI request.

  December 19, 2017

   · 

  4 min read
• Biotech Bay

  Bigfinite Raises $8.5M Seed Round to Help Pharma Industry Optimize its Drug Manufacturing Process

  Bigfinite today announced that it has raised $8.5M in a seed round of financing led by Crosslink Capital, Uncork Capital and La Famiglia.

  December 19, 2017

   · 

  3 min read
• Avista Pharma Solutions Expands Drug Product cGMP Manufacturing at Colorado Site

  Avista has completed extensive facility upgrades at its Longmont, Colorado site, expanding its drug product manufacturing footprint by approximately 20,000 square feet and allowing for the formulation and manufacture of new dosage forms.

  December 19, 2017

   · 

  3 min read
• Policy

  MiMedx Agrees to Lawsuit Settlement With Former Employee

  MiMedx has reached a mutually agreeable settlement in its lawsuit with former employee, William T. Mills, who voluntarily resigned from MiMedx in January 2017.

  December 19, 2017

   · 

  3 min read
• Business

  InnerScope Hearing Technologies Engages Market Domination LLC. and its CEO as the Outsourced CMO to Expand its Direct-to-Consumer Multi-channel E-commerce Strategy

  Effective immediately, Mr. Greene will oversee the Company’s brand strategy, marketing operations as well as playing a key role in expanding the company’s footprint into several marketing and direct-to-consumer distribution channels.

  December 19, 2017

   · 

  5 min read
• Business

  Pfenex Earns $18.5M in Milestones and Updates Worldwide License and Option Agreement With Jazz Pharma

  Pfenex today announced the amendment of the 2016 agreement under which Pfenex granted Jazz Pharma worldwide rights to develop and commercialize multiple early stage hematology product candidates.

  December 19, 2017

   · 

  5 min read