has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates, has entered into a strategic partnership with Bioeq AG, a Swiss biopharmaceutical company. The deal is for the licensing, supply and commercialisation of Bioeq’s Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO, an interchangeable biosimilar of Lucentis® (Ranibizumab) for the US market. The Biologics License Application (BLA) for NUFYMCO® has been approved by the US Food and Drug Administration (USFDA) on December 18. This transaction marks an expansion of Zydus’ US biosimilar business, following its recent partnership with Formycon AG for a biosimilar of Keytruda (Pembrolizumab).
an innovation-led global biopharmaceutical company, has announced the signing of an out-licensing agreement with Ajanta Pharma Ltd, a specialty pharmaceutical formulations company, to market its vertically integrated drug product, Semaglutide, used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will be responsible for supplying Semaglutide to Ajanta for exclusive marketing in 23 countries and semi-exclusive marketing in 3 countries across Africa, Middle East and Central Asia.
has informed the exchanges that the United States Food and Drug Administration (USFDA) has issued a No Action Indicated (NAI) classification for its facility located in Kadu, Surendranagar, following the completion of a regulator inspection.