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Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Shots:The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposideApproval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…

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Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M

Shots:Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950MAs per the deal, Royalty Pharma will acquire BeOne’s ~7% royalty on global Imdelltra sales for ~$950M, including $885M upfront and an option for BeOne to sell more for $65M within 12mos. The royalty, including shared sales above $1.5B…

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Jazz Pharmaceuticals

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots:The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025)The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…

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