20+ Orelabrutinib Studies Presented at ASH Annual Meeting
Post-cycle 6 in newly diagnosed primary CNS lymphoma treated with orelabrutinib, rituximab, and high-dose methotrexate, objective responses reached 89.5%...
Medicenna Reveals New MDNA11 Clinical Data in Live Webinar
Medicenna will unveil updated ABILITY-1 Phase 1/2 data for its long-acting IL-2 superkine MDNA11—both as monotherapy and in combination...
Praxis & FDA Align on Accelerated Pathway for SCN2A Drug
Praxis secured FDA agreement to convert EMBRAVE3, its registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy,...
FDA Approved: Amneal’s New Epinephrine for U.S. Hospitals
Amneal secured FDA approval for epinephrine injection USP, 1 mg/mL, in 1 mL single-dose and 30 mL multi-dose vials...
Promising 48-Month Azetukalner Epilepsy Study Data by Xenon
Among adults with focal onset seizures in Xenon’s ongoing X-TOLE open-label extension, monthly median percent reduction in seizure frequency...
RAP-219’s Consistent Clinical Response in Focal Seizures
RAP-219 cut median clinical seizure frequency by 77.8% over eight weeks in a 30-patient Phase 2a study of drug‑resistant...
Cretostimogene Data: Potential Backbone Therapy for NMIBC
High-grade event-free survival in BCG-unresponsive papillary-only NMIBC reached 95.7%, 84.6%, and 80.4% at 3, 6, and 9 months, respectively,...
Pociredir’s Promising Results in Sickle Cell Disease Trial
Mean absolute HbF rose 9.9% at Week 6 in the 20 mg cohort of Fulcrum’s Phase 1b PIONEER study,...
TScan’s Alloha Phase 1 Heme Trial Shows Positive Data
Relapse-free survival favored TSC-101 over standard transplant alone in the Phase 1 ALLOHA study with a hazard ratio of...
Transforming Oversight Under ICH GCP E6 R3: A Conversation with Pinar Bénet
At the Veeva Clinical Oversight Forum, we spoke with Pinar Bénet, Senior Director of GTM Strategy and Clinical Lead...