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Astellas has partnered with Vir Biotechnology to advance VIR-5500, a PRO-XTENÂ dual-masked CD3 T-cell engager targeting PSMA, for the treatment of prostate cancer
As per the deal, Astellas will fund 60% & Vir 40% of global development costs; Vir will continue the P-I trial until transition, after which Astellas will assume development. Also, Vir will…
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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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The company has reported dosing of the first patient in the US Â 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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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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The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer
Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies
IsoPSA, a…
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J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline
As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months
Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…
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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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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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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.Â
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 LimitedÂ
Raphaël…
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FDA has granted FTD to Cu-64 SAR-bisPSMA for PET scans of PSMA+ lesions in pts with BCR post-receiving SoC, based on a P-I/II (COBRA) trial assessing it (same & next day) in patients who had an SoC scan at study entry
Study showed that it localized disease in ~80% patients & detected double the…

