Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
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Novartis’ sickle cell disease therapeutic Adakveo (crizanlizumab) is under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use after failing to replicate previous efficacy results in a Phase III trial.
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The Type A Meeting has been scheduled to occur on January 11, 2023.
In a head-to-head comparison trial, BeiGene’s Brukinsa (zanubrutinib) bested Janssen’s Imbruvica (ibrutinib) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
Exelixis’ cancer portfolio stumbled Thursday as the Alameda, CA-based company reported that a Phase III study of cabozantinib in combination with Roche’s Tecentriq (atezolizumab) failed to hit the primary endpoint of overall survival in second-line non-small cell lung cancer.
Novartis reported Thursday that a Phase III trial of iptacopan met its primary endpoint in paroxysmal nocturnal hemoglobinuria (PNH) – the company’s second win in this indication in as many months.
The company reported Onivyde and 5 fluorouracil/leucovorin and oxaliplatin demonstrated a statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen. The study also met its key secondary endpoint of progression-free survival.
GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses. The trial is expected to begin in the first half of 2023.
Two Phase III trials of Genentech (Roche)’s Vabysmo hit the primary endpoint in macular edema caused by branch and central retinal vein occlusion (BRVO), showing non-inferiority to Regeneron’s Eylea.
New Phase III data shows Novartis’ experimental iptacopan demonstrated superiority against AstraZeneca subsidiary Alexion’s Soliris and Ultomiris in paroxysmal nocturnal hemoglobinuria (PNH).