BioSpace News Archive

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• Policy

  Oasmia Pharma Receives Marketing Approval for Paclical in Kazakhstan

  Paclical will be sold through Hetero Group and is planned to be launched during the first half of 2018.

  December 11, 2017

   · 

  1 min read
• Business

  Ionis Pharma Licenses IONIS-HTT Rx to Partner Following Successful Phase I/II Study in Patients With Huntington’s Disease

  Roche will now be responsible for all development and commercial activities.

  December 11, 2017

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  7 min read
• Policy

  FDA Accepts BLA to Review Eli Lilly’s Galcanezumab for the Prevention of Migraine in Adults

  Lilly announced the submission of the BLA on its third-quarter earnings call in October 2017.

  December 11, 2017

   · 

  5 min read
• Business

  BD Establishes Product Security Partnership Program to Enhance Cybersecurity of Medical Technology

  BD today announced it has established a Product Security Partnership Program that emphasizes collaboration across the health care industry to enhance cybersecurity of medical technology and devices.

  December 11, 2017

   · 

  5 min read
• Policy

  Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of EYLEA (aflibercept) Injection for Patients With Wet AMD

  Under the PDUFA, the goal for a standard review of an sBLA is ten months from submission for a target action date of August 11, 2018.

  December 11, 2017

   · 

  10 min read
• Genetown

  Pillar Biosciences Announces Issuance of China and U.S. Patents Covering SLIMamp Technology

  The SIPO of the People’s Republic of China issued patent ZL201680001111.1 with a duration of 20 years.

  December 11, 2017

   · 

  2 min read
• Business

  Radient Technologies Announces Master Services Agreement With Terra Life Sciences

  Radient Technologies Inc. announces the signing of a Master Services Agreement to produce cannabis extracts for the Terra Life Sciences group.

  December 11, 2017

   · 

  3 min read
• Drug Development

  Sophiris Bio Announces Complete Enrollment in Phase IIb Topsalysin Study of Localized Prostate Cancer

  Sophiris Bio today announced that it has completed enrollment in its Phase 2b study to evaluate the safety and tolerability of topsalysin in treating men with clinically significant localized prostate cancer.

  December 11, 2017

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  6 min read
• Business

  MilliporeSigma Signs Distribution Agreement With Avanti Polar Lipids

  Under the terms of the agreement, MilliporeSigma will employ its sales, marketing and e-commerce expertise to distribute Avanti Polar Lipid’s research lipid portfolio.

  December 11, 2017

   · 

  3 min read
• Biotech Bay

  Genomic Health Presents New Data Demonstrating Value of Oncotype DX to Optimize Breast Cancer Outcomes and Reduce Treatment Burden Throughout Disease Continuum

  The analysis demonstrated that Recurrence Score results significantly predicted the likelihood of clinical response to neoadjuvant therapy.

  December 11, 2017

   · 

  10 min read