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New York Blood Center

www.nybloodcenter.org

Latest From New York Blood Center

Tech Transfer Roundup: Roivant Taps Research Labs For New Gene Therapies

In tandem with Roivant, Cincinnati Children’s launches spinout Aruvant focused on hematologic disorders and separately teams with BridgeBio on genetic disease therapies. Roivant spinout Axovant licenses gene therapy candidates from University of Massachusetts.

Business Strategies Commercial

CBER’s 2012 Approval Count Is Average, But Its On-Time Review Performance Exceeded Expectations

FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).

BioPharmaceutical Approvals

CBER’s 2012 Approval Count Is Average, But Its On-Time Review Performance Exceeded Expectations

FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).

BioPharmaceutical Regulation

FDA’s Banner Year for Drug Approvals: Time to Change the Focus

FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.

BioPharmaceutical Drug Approval Standards
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Company Information

  • Industry
  • Services
  • Therapeutic Areas
  • Alias(es)
  • Ownership
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Company Type
  • Tech. Transfer Entity
  • Parent & Subsidiaries
  • New York Blood Center
  • Senior Management
  • Robert L Jones, MD, Pres.
  • Contact Info
  • New York Blood Center
    Phone: (212) 570-3155
    150 Amsterdam Ave.
    New York, NY 10023
    USA
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