Organic Chemical
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024
Bristol Myers Squibb’s Zeposia Misses Mark in Phase 3 Crohn’s Disease Study
Bristol Myers Squibb, Zeposia (ozanimod), Phase 3 Trial Setback, Crohn’s Disease, Clinical Remission Endpoint Not Met, YELLOWSTONE Program, Unmet Medical Need in Crohn’s Treatment
Medicare Coverage Gap Linked to Reduced Prescription Rates for GLP-1 Weight Loss Drugs
GLP-1 drugs, Medicare coverage gap, Lower prescription rates, Obesity treatment, Semaglutide (Wegovy), Tirzepatide (Mounjaro), Liraglutide (Saxenda), Healthcare costs, Truveta study
FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults
Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data
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
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
EU Approves Novo Nordisk’s Groundbreaking Once-Weekly Basal Insulin Icodec for Adults with Diabetes
Novo Nordisk, Once-Weekly Insulin Shot, Awiqli, Insulin Icodec, European Medicines Agency (EMA), CHMP Positive Opinion, Type 1 & Type 2 Diabetes Treatment
FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients
FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects
Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing
Crinetics Pharmaceuticals, Paltusotine, Acromegaly, Phase III trials, FDA submission, Oral treatment, Symptom reduction
Takeda’s $5.2B Ariad Deal Yields Label Expansion for Iclusig in Rare Leukemia
Takeda, Ariad, $5.2B deal, Iclusig, Label expansion, Rare form of leukemia