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Celltrion
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, 2025
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, 2025
Roche to Acquire 89bio for ~$3.5B, Strengthening its CVRM Portfolio
Shots: Roche has entered into a definitive merger agreement to acquire 89bio, incl. its lead asset pegozafermin (FGF21 analog) for metabolic dysfunction-associated steatohepatitis, expanding cardiovascular, renal, & metabolic disease portfolio   As per the deal, Roche will acquire 89bio for $14.5/share in an all-cash transaction totaling ~$2.4B, along with one non-tradeable CVR up to an…
September 18, 2025
Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…
September 18, 2025
Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)
Shots: The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…
September 18, 2025
Astrazeneca
AstraZeneca Reports Interim P-III (TULIP-SC) Trial Data of Saphnelo for Systemic Lupus Erythematosus (SLE)
Shots: AstraZeneca has reported interim P-III (TULIP-SC) trial data assessing Saphnelo (anifrolumab; 120mg, SC, QW, accessorisedPFS) vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC Interim analysis conducted after the first 220 pts reached Wk. 52, showed Saphnelo reduced disease activity (1EP), measured by BICLA at Wk. 52; data to be…
September 18, 2025
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