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Merck
NEWS

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025 MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…
March 13, 2025

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Merck
NEWS

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025    MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…
March 13, 2025

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Johnson & Johnson
NEWS

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Shots: The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System…
March 13, 2025

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Pierre Fabre & RedRidge Bio
NEWS

Pierre Fabre Laboratories and RedRidge Bio Enter R&D Collaboration & License Agreement for Biparatopic Antibody (BPA) Candidates

Shots: Pierre Fabre has partnered with RedRidge for BPA drugs against various targets in oncology, dermatology & rare diseases, where the latter will engineer, screen, & characterize BPAs for jointly selected targets, while Pierre will advance 2 co-development programs As per the deal, RedRidge will hold marketing rights in the US, Canada, & Japan…
March 12, 2025

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J&J & Nosis Bio
NEWS

Nosis Biosciences Partners with Janssen Biotech for Cell-Targeted RNA Drugs

Shots: Nosis Biosciences has entered into a strategic collaboration with Janssen Biotech (subsidiary of J&J) to design & develop cell-targeted RNA medicines The collaboration leverages J&J’s drug discovery & clinical expertise as well as Nosis’ Connexa platform to design drugs with extra-hepatic access to multiple & hard-to-target cell types involved in chronic diseases …
March 12, 2025

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Geron
NEWS

Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Shots: The EC has approved Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy in 30 EEA states; commercialization to begin in select EU states by 2026 pending country-by-country reimbursement Approval was based on P-III (IMerge) study of Rytelo vs PBO…
March 12, 2025

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