Phase III
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.
Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.
Novartis’ gene therapy Zolgensma is again under a cloud of doubt after Nature Biotechnology retracted its 2010 article noting “issues” regarding data cited in a key figure in the report.
Albireo Pharma reported dazzling Phase III ASSERT data of Bylvay for Alagille syndrome (ALGS). The company is headed to U.S. and European regulators with expectations of regulatory filings in Q1 of 2023.
Data from an ongoing Phase III trial showed Sanofi/Regeneron’s Dupixent can induce histological disease remission in young EoE patients aged 1–11.
SIFI, BeiGene and Novo Holdings shared promising updates on their proposed treatments for acanthamoeba keratitis, relapsed or refractory CCL and myasthenia gravis.
Janssen Pharmaceutical announced data on Monday from two Ulcerative colitis (UC) trials: the UNIFI trial studying Stelara and the VEGA trial studying guselkumab and golimumab.
Top-line data from the Phase III STELLAR trial revealed that Merck’s activin receptor candidate sotatercept reached its primary endpoint in pulmonary arterial hypertension.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.
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