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HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots:China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapyNDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…

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Akesobio

Akeso’s Cadonilimab Receives the NMPA’s Approval for 1L Treatment of Cervical Cancer

Shots:The NMPA has approved cadonilimab + Pt-based CT ± Avastin as a 1L treatment of persistent, recurrent, or metastatic cervical cancerApproval was based on the P-III (COMPASSION-16) trial assessing cadonilimab vs SoCs, which met its PFS & OS endpoints, showing efficacy in PD-L1-negative tumors (CPS <1; 27.9% vs 24.2%) with subgroup analyses demonstrating benefit…

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Alvotech & Dr. Reddy’s

Alvotech Collaborates with Dr. Reddy’s to Co-Develop a Biosimilar Version of Keytruda

Shots:Alvotech has entered into a collaboration & license agreement with Dr. Reddy’s to co-develop, manufacture & commercialize a biosimilar version of Merck's Keytruda (pembrolizumab) globallyAs per the deal, Alvotech & Dr. Reddy’s will jointly develop & manufacture the biosimilar candidate, sharing costs & responsibilities, with each retaining the right to commercialize it globally,…

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Cullinan and Genrix Bio

Cullinan Therapeutics Enters a ~$712M Licensing Deal with Genrix Bio for Velinotamig

Shots:Genrix Bio has granted Cullinan exclusive global license to velinotamig, excl. Greater China for all indications, with Cullinan planning to develop it in autoimmune diseasesAs per the deal, Genrix will receive $20M upfront, ~$292M in development & regulatory milestones & ~$400M in sales-based milestones, with net sales-based tiered royalties from mid-single digits up to…

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Eli Lilly and Camurus

Eli Lilly Licenses Camurus’ FluidCrystal Technology to Advance Long-Acting Incretin Products

Shots:Camurus has granted Eli Lilly exclusive global rights to research, develop, manufacture, & commercialize long-acting incretin drugs using Camurus’ FluidCrystal tech for cardiometabolic diseases As per the deal, Camurus will receive ~$290M in upfront, development & regulatory milestones as well as $580M in sales-based milestones & global net sales-based tiered royalties in mid-single digits…

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Mitigating Cardiovascular Therapy Gaps: Saif Rathore and Andrew Epstein in a Riveting Conversation with PharmaShots

Mitigating Cardiovascular Therapy Gaps: Saif Rathore and Andrew Epstein in a Riveting Conversation with PharmaShots

Shots: Did you know that coronary stent usage can decline by 20 percent if GLP-1 therapy is used as widely as statin therapy? PharmaShots welcomes Saif Rathore, Founder of Sandbar Life Sciences and Entrepreneur-in-Residence at Yale Ventures, and Andrew Epstein, Principal at Medicus Economics, for an illuminating dialogue exchange Saif and Andrew highlight the untapped…

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