Servier

The European Medicines Agency's CHMP has issued a positive opinion recommending approval of vorasidenib (Voranigo) for treating grade 2 IDH-mutant glioma in patients aged 12 years and older following surgical resection.

BioMed X and Servier have launched the first XSeed Labs in Europe at the Spartners incubator in Paris-Saclay, implementing a crowdsourcing model that embeds academic researchers within pharmaceutical R&D facilities.

A post-hoc analysis of the Phase III NAPOLI 3 trial identified characteristics associated with long-term survival in metastatic pancreatic adenocarcinoma patients treated with the NALIRIFOX regimen.

Servier will showcase its precision medicine research for IDH-mutated cancers at the 2025 ASCO Annual Meeting in Chicago, focusing on chondrosarcoma, cholangiocarcinoma, and myelodysplastic syndrome.

• Servier has secured global rights to develop and commercialize BDTX-4933, a Phase 1 targeted therapy designed to address both RAS mutations and RAF alterations in solid tumors, particularly non-small cell lung cancer. • The agreement includes a $70 million upfront payment to Black Diamond Therapeutics, with potential for up to $710 million in additional milestone payments plus tiered royalties on global sales. • BDTX-4933 is currently in Phase 1 trials evaluating safety, dosing, and efficacy in patients with advanced cancers harboring BRAF, CRAF, or NRAS mutations, positioning it as a potential best-in-class treatment for RAF/RAS-mutant solid tumors.

• Medable Inc. has received CNIL approval to operate its eConsent and eCOA solutions in eight countries outside the EU, marking a significant expansion of digital clinical trial capabilities. • The company partnered with French pharmaceutical giant Servier to achieve this regulatory milestone, demonstrating platform validation and enhanced security measures through a rigorous six-month process. • Medable's digital platform has shown impressive results across 300+ trials globally, including 90% eCOA adherence and potential ROI of up to $39 million for Phase III trials.

Oncodesign Precision Medicine (OPM) has reacquired the rights to its OPM-201 program for Parkinson's disease treatment from Servier.

The addition of blinatumomab to chemotherapy significantly improves the 3-year disease-free survival rate in pediatric patients with standard-risk B-cell acute lymphoblastic leukemia.

Novel triplet therapies are demonstrating significant positive results in treating relapsed/refractory and newly diagnosed leukemias, according to multiple clinical trials.

Vorasidenib demonstrates a significant and sustained improvement in progression-free survival (PFS) compared to placebo in adults with IDH-mutant low-grade glioma.