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AGC Biologics

http://www.agcbio.com/

Latest From AGC Biologics

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.

Companies Regulation

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.

Sales & Earnings India

Provention Bio’s Teplizumab Delays Type 1 Diabetes Onset, US FDA Says

Advisory committee to consider whether two-year delay is clinically meaningful and substantial evidence standard is satisfied; notably, panel input is not requested on an issue that has tripped up BLA review - bridging data that suggest pharmacokinetic differences between the clinical trial and commercial drug products.

Advisory Committees Drug Review
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    • AGC Biologics
    • MolMed S.p.A.
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