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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
TOP 20
Top 20 Monoclonal Antibodies of 2025 
Shots:  Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas  As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…
September 18, 20250Comments
NEWS
VectorY Therapeutics Collaborates with Shape Therapeutics to Develop Vectorized Antibodies for Neurodegenerative Diseases
Shots: VectorY has entered into an option & license deal with Shape to assess Shape’s SHP-DB1 (AAV capsid) for vectorized Abs payloads against 3 targets & may secure an exclusive license for their delivery if evaluation succeeds As per the deal, VectorY will handle development & commercialization of resulting therapies in exchange for an upfront…
September 18, 20250Comments
NEWS
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, 20250Comments
NEWS
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, 20250Comments
NEWS
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, 20250Comments
Astrazeneca
NEWS
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, 20250Comments