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AGC Biologics

http://www.agcbio.com/

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

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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.

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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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Strides Fights COVID-19-Led Sales Slump With Endo Assets, Sputnik V

After a COVID-19-led manufacturing halt at its India facility and a slowdown in US launches hit Strides during the first quarter of FY22, the Indian firm is trying to fight back with an acquisition of assets from Endo and a growth strategy for Stelis Biopharma’s vaccines business, led by Sputnik V.

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    • AGC Biologics
    • MolMed S.p.A.
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