BioSpace News Archive

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• Epigenomics AG gets CE-IVD Mark for Lung Cancer Test Epi proLung

  Epi proLung is a highly innovative lung cancer test based on the combination of Epigenomics’ proprietary DNA methylation biomarkers.

  December 19, 2017

   · 

  1 min read
• Drug Development

  BioMarin Doses First Patient in Global GENEr8-1 Phase III Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

  BioMarin announced today that it has dosed the first patient in the global GENEr8-1 Phase 3 study with the 6e13 vg/kg dose for valoctocogene roxaparvovec.

  December 19, 2017

   · 

  6 min read
• Business

  Otsuka and X-Chem Enter Into a Drug Discovery Research and License Collaboration

  Under the terms of the agreement, X-Chem will utilize its DNA-encoded library (DEXTM) screening and informatics platform to search for novel drug leads for several Otsuka discovery targets.

  December 19, 2017

   · 

  3 min read
• 

  Business

  SoCal Biotech Inks Pact With Biogen For Spinal Muscular Atrophy Drug Development

  Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization.

  December 19, 2017

   · 

  9 min read
• Policy

  U.S. FDA Approves Pfizer’s BOSULIF (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)

  The sNDA was reviewed and approved under the FDA’s Priority Review and accelerated approval programs based on molecular and cytogenetic response rates.

  December 19, 2017

   · 

  13 min read
• NRGene Delivers First-Ever Food Potato Genomes

  NRGene, the worldwide leader in genomic assembly and analysis, is working with a team of researchers from Wageningen University & Research in the Netherlands and leading commercial partners to create multi-genome mapping of commercial food potatoes.

  December 19, 2017

   · 

  3 min read
• Policy

  Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

  Samsung Bioepis today announced that the FDA has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin (trastuzumab).

  December 19, 2017

   · 

  1 min read
• Drug Development

  OSE Immunotherapeutics Presents New Data Analysis Supporting Continued Development of OSE-127 in Inflammatory Bowel Diseases

  The presentation reported results from a transcriptomic analysis of colon biopsies in more than 500 patients and 100 controls in a large database available for specialized bioinformaticians.

  December 19, 2017

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  7 min read
• Drug Development

  REGENXBIO Announces IND Active for Phase I/II Trial of RGX-121 to Treat Mucopolysaccharidosis Type II

  RGX-121 has received orphan drug designation as well as rare pediatric disease designation from the FDA.

  December 19, 2017

   · 

  7 min read
• Drug Development

  Faron Pharma Oy: Study Update: Traumakine Phase II/III INFORAAA Trial for Multi-Organ Failure Receives Recommendation From IDMC

  Faron Pharma announces that it has received the first recommendation from the IDMC of the INFORAAA study to continue the trial as planned using Faron’s wholly owned lead product, Traumakine.

  December 19, 2017

   · 

  5 min read