PARIS, France – AB Science SA today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e. a medical use patent) with its lead compound masitinib, based on findings from study AB06006. This new European patent...
treatment News
SHANGHAI, China — Abbisko Therapeutics Co., Ltd. announced the completion of patient enrollment for its pivotal Phase III trial, MANEUVER (ABSK021-301) STUDY, for evaluating the efficacy and safety of pimicotinib in patients with tenosynovial giant cell tumor (TGCT). A total of 94 patients were enrolled and exceeded the original target...
SHANGHAI — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023. The two clinical updates include reporting the design of...
SHANGHAI, China — Abbisko Therapeutics announced that its investigational innovative CSF-1R inhibitor pimicotinib（ABSK021) has been granted orphan drug designation by the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Following the successful ODD granted by the EMA, the product will benefit from incentives, including...
NORTH CHICAGO, Ill. – AbbVie today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson’s medicinal products have not given satisfactory results. PRODUODOPA is...
NORTH CHICAGO, Ill. — AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these...
TOULOUSE, France – ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to innovative therapies for patients, today announces positive clinical results from CER-001 in the LCAT (lecithin-cholesterol acyltransferase) deficiency disease published in the Annals of Internal Medicine. The patient with inherited mutations in the lecithin-cholesterol...
LUND, Sweden — Abliva AB (Nasdaq Stockholm: ABLI), a clinical-stage company developing drugs for the treatment of rare and severe primary mitochondrial disease, today announced a positive outcome of the interim analysis for FALCON, the potentially registrational study evaluating KL1333 in patients with primary mitochondrial disease. The study evaluates fatigue...
– Trofinetide met co-primary efficacy endpoints demonstrating statistically significant improvement over placebo in the Rett Syndrome Behaviour Questionnaire (RSBQ) (p=0.0175) and the Clinical Global Impression of Improvement (CGI-I) (p=0.0030) – Trofinetide met key secondary endpoint demonstrating statistically significant improvement over placebo in CSBS-DP-IT–Social (p=0.0064), caregiver scale of ability to communicate...
SAN DIEGO, Calif. — Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that Health Canada has accepted its New Drug Submission (NDS) for trofinetide for the treatment of Rett syndrome, a rare neurodevelopmental disorder. Health Canada has granted Priority Review for Acadia’s submission. “Rett syndrome is a profoundly debilitating and complex...