Clinical Research
Aixial Group Partners with Medidata to Enhance Clinical Trial Efficiency
Aixial Group, Medidata, clinical trial data, Single Source of Truth, data management, clinical research, patient data privacy, database lock.
Roche’s Fenebrutinib Shows Promising Results in Relapsing Multiple Sclerosis Phase II Trial
Roche, fenebrutinib, relapsing multiple sclerosis, BTK inhibitor, Phase II trial, FENopta study
Mpox Outbreak in Africa: Siga’s Tpoxx Antiviral Falls Short in Congo Study
mpox, Tpoxx, antiviral, Congo study, Africa outbreak, Siga, tecovirimat
Novo Nordisk Pursues FDA Filing for Once-Weekly Insulin and Semaglutide Combo After Icodec Rejection
Novo Nordisk, insulin icodec, semaglutide, FDA filing, type 2 diabetes, once-weekly insulin, IcoSema, COMBINE-1 study, regulatory approval
Lykos Faces Significant Setbacks as FDA Rejects MDMA Therapy and Three Studies Are Retracted Due to Unethical Conduct
Lykos Therapeutics, MDMA therapy, FDA rejection, study retractions, unethical conduct, PTSD treatment, psychedelic research
Apellis and Sobi Achieve Significant Breakthrough in Phase 3 Trial for Rare Kidney Disease Treatment
Apellis Pharmaceuticals, Sobi, pegcetacoplan, Phase 3 VALIANT study, C3 glomerulopathy, primary immune complex membranoproliferative glomerulonephritis, proteinuria reduction, kidney disease treatment, FDA approval, European Medicines Agency
IDRx Secures $120M for Pivotal KIT Inhibitor Study with Promising Early Data
IDRx, KIT inhibitor, pivotal study, funding, cancer treatment, biotech
Actinium’s Radioconjugate Faces Setback as FDA Requests New Study
Actinium Pharmaceuticals, radioconjugate, FDA, new study, Iomab-B, regulatory affairs, biotech, cancer treatment
Agios’ Pyrukynd Misses Primary Endpoint in First Pediatric Study for Rare Blood Disorder
Agios Pharmaceuticals, Pyrukynd, mitapivat, PK deficiency, pediatric study, blood disorder, Phase 3 ACTIVATE-KidsT study
Eisai’s Alzheimer’s Drug Leqembi Shows Long-Term Benefits, Despite Study Limitations
Eisai, Leqembi, Alzheimer’s drug, long-term benefits, study limitations, cognitive decline, amyloid plaques, Biogen