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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
Debiopharm Enters a ~$267M Licensing Deal with Repare Therapeutics for Lunresertib
Shots: Debiopharm has entered into an exclusive global licensing agreement with Repare Therapeutics for lunresertib (PKMYT1 inhibitor) to treat difficult-to-treat solid tumors As per the deal, Repare will receive $10M upfront, ~$257M in clinical, regulatory, commercial & sales milestones, incl. $5M in near-term payments & net sales-based single-digit royalties Debiopharm will assume sponsorship of P-I (MYTHIC)…
July 16, 2025
Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval
Shots: The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog Kirsty is a rapid-acting human…
July 16, 2025
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