Finding
Eli Lilly’s Zepbound Shows Promising Results in Reducing Sleep Apnea Severity in Pivotal Trials
Eli Lilly, Zepbound, Sleep Apnea, Obstructive Sleep Apnea (OSA), Pivotal Trials, Obesity, GLP-1 Receptor Agonist, Tirzepatide, CPAP, Weight Loss
Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing
Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing
Neumora Therapeutics’ Schizophrenia Drug NMRA-266 Faces FDA Hold Over Convulsions in Rabbits
Neumora, United States Food and Drug Administration, NMRA-266, Seizures, Schizophrenia
EU Regulators Confirm No Link Between GLP-1 Drugs and Suicidal Thoughts
GLP-1 drugs, Ozempic, Wegovy, European Medicines Agency (EMA), No link to suicidal thoughts, Investigation
AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11
AstraZeneca, FASENRA, Benralizumab, Severe Asthma, Pediatric Label Expansion, FDA Approval, Children Aged 6-11
Enhanced Optimization for Influenza B Strains Planned in CureVac’s mRNA Seasonal Flu Vaccine Trials
CureVac, mRNA flu vaccine, Influenza B strains, Targeted optimization, Phase 2 studies, Multivalent candidate, Improved immune response, Collaboration with GSK
Verve Temporarily Halts Lead Base Editing Study Following Adverse Event, Prioritizes Alternative Therapy
Verve Therapeutics, Lead base editing program, Adverse event, VERVE-101, Serious adverse events (SAEs), Grade 3 ALT elevation, Thrombocytopenia, Pause enrollment in Heart-1 study, Alternative therapy focus: VERVE-102, Ionizable lipid delivery system, Phase Ib Heart-2 clinical trial, Q2 2024 initiation of Heart-2 clinical trial.
Pfizer Continues FDA Approval Expectations for Sickle Cell Disease Therapy Despite Terminating One Phase 3 Trial
Pfizer/ Sickle Cell Disease/ FDA Approval/ Inclacumab/ THRIVE Program/ Monoclonal Antibody/ Terminated Trial/ Poor Accrual
AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD
AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency
Axsome Therapeutics’ Small Molecule AXS-12 Successful in Phase III Narcolepsy Trial
Axsome Therapeutics, AXS-12 (reboxetine), Phase III trial, Narcolepsy, Cataplexy reduction, Improved cognition/ memory/ sleepiness severity, Safety profile