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NKGen Biotech Partners with HekaBio to Accelerate Troculeucel Development in Japan
Shots: NKGen Biotech has partnered with HekaBio to accelerate the regulatory, manufacturing & commercial development of troculeucel in Japan As per the collaboration, HekaBio will lead trials & handle regulatory activities with Japan’s PMDA for pre-market approval of troculeucel in neurodegenerative diseases, incl. Alzheimer’s & Parkinson’s. Also, HekaBio aims for first pts dosing in Japan…
July 18, 2025
Keros Therapeutics Reports First Patient Dosing in P-III (RENEW) Trial of Elritercept for Transfusion-Dependent Anemia in Adults with MDS
Shots: Keros has dosed the first pts in P-III (RENEW) trial assessing elritercept vs PBO in adults with transfusion-dependent anemia with very low, low, or intermediate risk myelodysplastic syndromes (MDS) Dosing triggers a $10M milestone under Keros & Takeda’s Jan 2025 deal, in which Takeda gained global rights to develop, manufacture, & commercialize elritercept (excl.…
July 18, 2025
The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Shots: The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…
July 18, 2025
Nicox and Kowa Enter a Licensing Agreement for NCX 470 to Treat Glaucoma
Shots: Nicox has granted Kowa exclusive global rights to develop & commercialize NCX 470 for glaucoma or ocular hypertension, excl. territories already licensed to Ocumension (China, Korea & Southeast Asia) & to Kowa (Japan) As per the deal, Nicox will receive $8.7M (€7.5M) upfront & near-term milestones tied to positive topline P-III (Denali) trial data…
July 17, 2025
The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles
Shots: The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use Additionally, Shingrix prefilled…
July 17, 2025
RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software
Shots: Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…
July 17, 2025
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