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Lupin & Steincares

Lupin Collaborates with SteinCares to Commercialize Ranibizumab Biosimilar in Latin America

Shots:Lupin & SteinCares have entered into a license & supply agreement to commercialize Lupin’s ranibizumab biosimilar in Latin America excl. Mexico & ArgentinaAs per the deal, SteinCares will be responsible for the biosimilar’s regulatory filings, registration, & commercialization in LATAM licensed states, while Lupin will oversee its manufacturingRanibizumab is a recombinant humanized…

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Regeneron

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Shots:Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…

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