BOSTON, April 8, 2024 /PRNewswire/ -- Servier, a science driven company focused on developing transformative precision therapies for patients, is poised to unveil promising preliminary data at the American Association for Cancer Research (AACR) Annual Meeting 2024. These submissions also demonstrate Servier's commitment to its One Innovation Engine approach to scientific advancements.
BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.
FDA and EMA Accept Vorasidenib Regulatory Submissions for diffuse glioma
DURHAM, N.C., Jan. 5, 2024 /PRNewswire/ -- Base4 Biotechnology (formerly known as Nymirum) today announced that it has expanded its license agreement with Servier to strengthen the companies' strategic collaboration to develop RNA-targeted small molecule therapeutics. This agreement leverages Base4's pioneering drug discovery platform to identify RNA-modulating small molecules to enable and accelerate Servier's research in neuroscience drug candidates.
French drugmaker Servier ordered to pay $471 million for Mediator scandal
Servier Showcases Leadership in Mutant Isocitrate Dehydrogenase (IDH) Inhibition
BOSTON, Dec. 5, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will present data in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12, 2023. The latest data underscores Servier's commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.
Servier`s Biologic Asparlas (Calaspargase Pegol-mknl) Receives Approval in the U.S.
BOSTON, Nov. 18, 2023 /PRNewswire/ -- New data from Servier's clinical development program for vorasidenib in IDH-mutant diffuse glioma, presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showed that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee. Additional data from the INDIGO study being presented at SNO include health-related quality of life data, indicating patients receiving vorasidenib experience preservation of quality of life, stable neurocognitive function, and seizure control, as well as translational data demonstrating vorasidenib's efficacy across IDH-mutant diffuse gliomas with various additional mutations.
Vorasidenib Data at SNO Bolster Servier's Neuro-Oncology Development Program