(IN BRIEF) Basilea Pharmaceutica has initiated FORWARD‑IM, a global Phase 3 trial evaluating fosmanogepix in adults with invasive mold infections. Building on positive Phase 1 and Phase 2 results—and following the FAST‑IC Phase 3 candidemia trial—this open‑label study will randomize about 160 patients to … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged Amplyx Pharmaceuticals, Aspergillus spp., BARDA, Basilea Pharmaceutica Ltd, broad‑spectrum antifungal, Candida auris, candidemia, Cresemba®, FAST‑IC, FDA Fast Track, FORWARD‑IM, fosmanogepix, Fusarium spp., HHS ASPR, invasive candidiasis, invasive mold infections, Lomentospora prolificans, Mucorales, orphan drug, Pfizer, phase 3 study, PSI CRO AG, QIDP, Zevtera®
(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged ASH 2024, autologous stem cell transplant, bortezomib, CHMP, dexamethasone, European Medicines Agency, GMMG-HD7, isatuximab, Journal of Clinical Oncology, lenalidomide, MRD negativity, Multiple Myeloma, NDMM, phase 3 study, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) Itepekimab, developed by Sanofi and Regeneron, met its primary endpoint in the AERIFY-1 phase 3 study for COPD, showing a 27% reduction in moderate or severe exacerbations at 52 weeks. However, the AERIFY-2 study did not achieve the … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged adverse events, AERIFY-1, AERIFY-2, Chronic obstructive pulmonary disease, clinical trials, COPD, COVID-19, drug efficacy, Exacerbations, IL33, Itepekimab, moderate exacerbations, monoclonal antibody, partnership, phase 3 study, Regeneron, regulatory authorities, research and development, Sanofi, severe exacerbations, therapeutic development
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