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News
CHMP Recommends Marketing Authorization for Obicetrapib in EU
21+ hour, 46+ min ago (478+ words) The Clinical Trial Vanguard CHMP Recommends Marketing Authorization for Obicetrapib in EU Even with 269 million lipid-lowering prescriptions written in the United States over the past twelve months, roughly 30 million adults remain above their risk-based LDL-C targets, and that stubborn gap…...
FDA Approves LYTENAVA, First Ophthalmic Bevacizumab for Wet AMD
21+ hour, 47+ min ago (382+ words) The Clinical Trial Vanguard FDA Approves LYTENAVA, First Ophthalmic Bevacizumab for Wet AMD Bevacizumab has been administered intravitreally in retina clinics for roughly two decades, driving the majority of first-line anti-VEGF treatment in wet AMD, all without a single FDA-approved…...
The Inherited Retinal Disease Trial That Should Change How Sponsors Think About AI Diagnostic Evidence
21+ hour, 55+ min ago (829+ words) The Clinical Trial Vanguard The Inherited Retinal Disease Trial That Should Change How Sponsors Think About AI Diagnostic Evidence Picture a geneticist at a tertiary retinal referral center, staring at a fundus autofluorescence image and a genetic panel that returned…...
Laminar Pharma Completes LAM561 Phase 2b/3 Trial in Glioblastoma
1+ day, 21+ hour ago (468+ words) The Clinical Trial Vanguard Laminar Pharma Completes LAM561 Phase 2b/3 Trial in Glioblastoma One interim signal has carried Laminar Pharma’s LAM561 program far enough to reach a full enrollment close, and the statistical design now does the waiting. The Spanish biotech announced last…...
Atsena Gets EMA Orphan Status for ATSN-101 and ATSN-201
1+ day, 21+ hour ago (241+ words) The Clinical Trial Vanguard Atsena Gets EMA Orphan Status for ATSN-101 and ATSN-201 Two orphan designations from the EMA in a single announcement is unusual, and the more meaningful detail is buried beneath the regulatory headline: Atsena’s pivotal Phase 3 cohort…...
Genmab, AbbVie Clarify Epcoritamab Phase 3 Trial Missed Primary Endpoint
1+ day, 21+ hour ago (395+ words) The Clinical Trial Vanguard Genmab, AbbVie Clarify Epcoritamab Phase 3 Trial Missed Primary Endpoint Six months after Genmab and AbbVie disclosed topline results from the Phase 3 EPCORE DLBCL-1 trial, the companies felt compelled to issue a public clarification on something that…...
The Hybrid Vaccine Trial Design That Could Render Pure RCTs Obsolete
1+ day, 21+ hour ago (943+ words) The Clinical Trial Vanguard The Hybrid Vaccine Trial Design That Could Render Pure RCTs Obsolete Picture a vaccine trial statistician staring at two spreadsheets side by side. On the left: a Phase 3 randomized controlled trial that enrolled 40,000 participants across five…...
LB Pharmaceuticals Accelerates NOVA-2 Schizophrenia Trial Readout
2+ day, 21+ hour ago (423+ words) The Clinical Trial Vanguard LB Pharmaceuticals Accelerates NOVA-2 Schizophrenia Trial Readout LB Pharmaceuticals is pulling forward the readout from its pivotal schizophrenia trial by a margin that, in a disease area where enrollment delays routinely stretch programs by a year…...
The 2-Week Window: What a Phase 1 iPSC Trial Teaches Us About Designing Cell Therapy Studies That Can Actually Win Approval
2+ day, 21+ hour ago (761+ words) The Clinical Trial Vanguard The 2-Week Window: What a Phase 1 iPSC Trial Teaches Us About Designing Cell Therapy Studies That Can Actually Win Approval Picture a neurosurgeon standing at a crossroads that lasts exactly 14 days. The patient arrived in the…...
FDA Accepts BridgeBio’s Encaleret NDA for Autosomal Dominant Hypocalcemia Type 1
2+ day, 21+ hour ago (105+ words) The Clinical Trial Vanguard FDA Accepts BridgeBio’s Encaleret NDA for Autosomal Dominant Hypocalcemia Type 1 A 76-point gap between treatment arms is not the kind of number regulators ignore. In BridgeBio’s Phase 3 CALIBRATE study, 76% of patients on encaleret achieved simultaneous serum…...