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Lenz Therapeutics and Lotus

LENZ Therapeutics Collaborates with Lotus Pharmaceutical to Commercialize LNZ100 in the Republic of Korea and Southeast Asia

Shots: LENZ has granted Lotus exclusive development, manufacturing, registration & marketing rights of LNZ100 to treat presbyopia in the Republic of Korea & certain Southeast Asian countries incl. Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia & Singapore As per the deal, LENZ will obtain ~$125M in upfront, regulatory & commercial milestones, along with double-digit net sales-based…

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Astrazeneca

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapy Imfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…

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PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below:    Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025  Read More: Recursion  Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…

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UTR Therapeutics

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

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Minghui Pharmaceutical & Qilu Pharmaceutical

Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C

Shots: Minghui has granted Qilu exclusive rights to develop, manufacture & market MHB088C in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan) As per the deal, Minghui will receive ~$185.9M (CN¥ 1.345B) incl. $38.7M as upfront & near-term milestone payments & ~$147.2M in development, regulatory & sales milestones, plus double-digit net sales-based royalties;…

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ALK

ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis

Shots: Health Canada has approved Itulatek (tree pollen sublingual tablet) to treat mod. to sev. seasonal allergic rhinitis &/or conjunctivitis, induced by pollen from birch, alder, hazel, &/or oak in pts (5-17yrs.); applications under the Swissmedic & MHRA’s review, with decision expected this year Approval was based on P-III (TT-06) trial assessing Itulatek vs PBO…

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ALPCO

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

Shots: ALPCO has launched its Calprotectin Immunoturbidimetric Assay for the diagnosis of IBD, incl. Crohn's disease & ulcerative colitis in the EU ALPCO has also enrolled 1st pts in its pivotal trial for FDA clearance of its automated chemiluminescent calprotectin assay on the KleeYa system, following completion of the FDA pre-submission in Mar 2025, with…

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