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Candel Therapeutics and RTW Enter Royalty Funding Agreement to Support the Launch Aglatimagene Besadenovec in Localized Prostate Cancer

Shots: Candel Therapeutics has entered into a $100M royalty funding agreement with RTW Investments, contingent on FDA approval of Aglatimagene Besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer As per the deal, RTW will receive a capped, tiered single-digit percentage of US annual net sales of aglatimagene. Candel Plans to submit a BLA for…

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Telix Pharmaceuticals

Telix Reports First US Patient Dosing in the P-III Trial of Illuccix and Gozellix, for the Diagnosis of Prostate Cancer

Shots: The company has reported dosing of the first patient in the US  P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting Building…

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Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Shots: FDA has granted 510(k) clearance to Vanquish Water Vapor System for prostate tissue ablation in pts with intermediate-risk, localized prostate cancer Clearance was supported by 12mos. follow-up data on 110 pts first enrolled in the ongoing VAPOR 2 trial (n=235) assessing Vanquish System across the US, with longer-term to support PMA submission 6mos. biopsy…

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GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer

Shots: Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC) As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…

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Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

Shots: The US FDA has approved Camcevi ETM (leuprolide mesylate, 21mg, Q3M LAI) for the treatment of advanced prostate cancer; Application is under the EMA’s review Approval was based on P-III trial assessing Camcevi ETM in 144 advanced prostate cancer pts, which showed superior efficacy, with 97.9% pts achieving the 1EP Camcevi (Q6M LAI) is…

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Viewpoints_Raphaël Ortiz

Enhancing Diagnostic Capabilities in Prostate Cancer: Raphaël Ortiz from Telix Pharmaceuticals in a Riveting Conversation with PharmaShots

Shots:  Telix Pharmaceuticals’ Illuccix is approved in the UK for detecting and localizing prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET imaging.  Amidst a shortage of PET imaging agents in the UK and mainland Europe, Telix Pharmaceuticals has secured a significant advantage through an exclusive distribution partnership with Xiel Limited  Raphaël…

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