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AGC Biologics

http://www.agcbio.com/

Latest From AGC Biologics

COVID-19 DNA Vaccine Halt Another Blow To AnGes

AnGes has terminated R&D work on a DNA vaccine for COVID-19 and will now look at intranasal candidates with a US partner. Although the original project received funding from the Japanese government, a spike in related costs caused the Japanese firm's net loss to triple last year, and the decision represents the latest in a string of pipeline setbacks.

Japan Coronavirus COVID-19

Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Approval Standards

Xbrane Joins Forces With Contract Manufacturer For Cimzia Biosimilar

Sweden’s Xbrane Biopharma has secured a manufacturing partner in its native Scandinavia, Denmark’s AGC Biologics, to help complete key steps for its proposed Xcimzane (certolizumab pegol) biosimilar to Cimzia ahead of Phase I and Phase III clinical trials.

Biosimilars Deals

Provention Maps Possible Regulatory Path For Troubled Teplizumab

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

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    • AGC Biologics
    • MolMed S.p.A.
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