BioSpace News Archive

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  FDA

  Shire Gets FDA Clearance for myPKFiT for Advate to Help Personalize Care for Hemophilia A

  The myPKFiT for ADVATE software represents an innovative approach to estimating a patient’s PK curve, a key measure for assessing drug exposure over time.

  December 19, 2017

   · 

  6 min read
• 

  Business

  Boehringer Ingelheim, Roche Forge Partnership for Inflammatory Bowel Diseases

  Together, Boehringer Ingelheim and Roche will leverage complementary expertise and innovative LNA technology to bring novel treatment approaches to IBD patients.

  December 19, 2017

   · 

  2 min read
• PharmaJet and Invectys Partner in Phase II Clinical Trial of DNA Cancer Vaccine

  PharmaJet received US FDA approval to proceed with a phase II clinical trial of its therapeutic cancer vaccine, INVAC-1, using the PharmaJet needle-free injection system.

  December 19, 2017

   · 

  2 min read
• Biotech Beach

  Zymo Research Receives SBIR-STTR Grant From the NIH

  Zymo Research has been awarded a Phase I Small Business Technology Transfer grant from the National Institutes of Health.

  December 19, 2017

   · 

  2 min read
• Pharm Country

  Pfizer Invites Public to View and Listen to Webcast of January 30 Conference Call With Analysts

  Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EST on Tuesday, January 30, 2018.

  December 19, 2017

   · 

  1 min read
• Drug Development

  Novavax Continues Phase III Trial of the RSV F Vaccine for Infants via Maternal Immunization and Provides Update on Phase I/II Trial of the NanoFlu Vaccine

  Novavax also provided an update on its nanoparticle influenza vaccine candidate with proprietary Matrix-M adjuvant.

  December 19, 2017

   · 

  7 min read
• Business

  Applied StemCell Appoints Gene Therapy Pioneer, Dr. Mark A. Kay, Director of the Human Gene Therapy Program at Stanford University, to Its Scientific Advisory Board

  He has organized several gene therapy related conferences worldwide, is a founding member of the American Society for Gene Therapy, and serves on the editorial board for prominent peer-reviewed publications.

  December 19, 2017

   · 

  2 min read
• 

  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
• 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