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WEEKLY SNAPSHOT
PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   
PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)    This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:    MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC  Read More: MAIA Biotechnology  Akeso Reports First…
September 19, 20250Comments
NEWS
Avant Technologies and Austrianova Form Joint Venture Klothonova to Develop Klotho-Based Cell Therapies
Shots: Avant Technologies and Austrianova signed a joint venture and licensing agreement to form Klothonova, a 50/50 Nevada-based Joint Venture focused on developing cell-based therapies using encapsulated Klotho-producing cells Under the terms of the agreement, Klothonova will leverage Austrianova’s proprietary cell-encapsulation technology to develop and commercialize therapies for Alzheimer’s disease, heart disease, cancer, kidney disease,…
September 19, 20250Comments
Intellia Therapeutics
NEWS
Intellia Therapeutics Completes Enrollment in the P-III (HAELO) Study of Lonvoguran Ziclumeran (lonvo-z) in Hereditary Angioedema (HAE) Patients
Shots: Intellia Therapeutics completed enrollment in the global P-III (HAELO) study evaluating lonvo-z for treating HAE, finishing within 9mos. since the first patient was dosed in Jan 2025, with nearly half of the participants enrolled from the US The study P-III (HAELO) study will evaluate the efficacy and safety of lonvo-z in ≥60 adults and…
September 19, 20250Comments
Celltrion
NEWS
Celltrion Receives the Health Canada’s Approval for Stoboclo and Osenvelt (Biosimilar, Prolia & Xgeva)
Shots: Health Canada has approved Stoboclo & Osenvelt (CT-P41), referencing biosimilar Prolia & Xgeva, for all approved indications of the reference drugs Approval was supported by P-III trial data in postmenopausal women with osteoporosis (PMO), showing CT-P41 matched reference denosumab in efficacy & PD, with similar PK, safety, and immunogenicity Stoboclo and Osenvelt are RANKL…
September 19, 20250Comments
Incyte
NEWS
Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)
Shots: The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…
September 19, 20250Comments
NEWS
LEO Pharma Reports Data from P-III Study of Delgocitinib Cream in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE)
Shots: LEO Pharma presented data from the P-III (DELTA TEEN) study, showing delgocitinib cream efficacy vs. cream vehicle in adolescents (12–17yrs.) with moderate to severe CHE; 63.5% achieved IGA-CHE treatment success vs. 29.2% with vehicle Delgocitinib cream also showed an edge across key 2EPs, including a ≥90% improvement (HECSI-90: 71.6% vs. 37.5%; HESD itch: 64.8%…
September 19, 20250Comments