Functional Concept
Eli Lilly’s Kisunla Shows Reduced Brain Swelling with Modified Dosing Regimen in Alzheimer’s Patients
Eli Lilly, Kisunla, Alzheimer’s disease, brain swelling, modified dosing regimen, ARIA-E risk reduction
Crescent Biopharma’s Public Debut Fueled by PD-1/VEGF Combination Therapy Enthusiasm
PD-1/PD-L1 inhibitors, VEGF inhibitors, Combination therapy, Cancer treatment, Biopharmaceutical industry, Public listing
Modified Dosing Regimen of Eli Lilly’s Alzheimer’s Drug Kisunla (Donanemab) Reduces Brain Swelling
Alzheimer’s disease, Eli Lilly, Kisunla (donanemab), Modified dosing regimen, ARIA-E (amyloid-related imaging abnormalities with oedema/effusion), Brain swelling, TRAILBLAZER-ALZ 6 Phase IIIb trial
Gilead Withdraws US Indication for Sacituzumab Govitecan in Metastatic Urothelial Cancer
Sacituzumab Govitecan, Trodelvy, Bladder Cancer, Urothelial Cancer, Gilead Sciences, FDA, Accelerated Approval Withdrawal
Fierce Pharma AsiaAstellas’ first-in-class FDA nod; Otsuka’s IgAN win; Samsung Bio’s $1.2B contract
United States Food and Drug Administration, IGA Glomerulonephritis, Sibeprenlimab, Contract agreement, Samsung, first
Intellia’s CRISPR Therapy NTLA-2002 Shows 81% Reduction in Hereditary Angioedema Attacks in Phase 2 Study
CRISPR therapy, Intellia Therapeutics, NTLA-2002, Hereditary Angioedema (HAE), Gene editing, Phase 2 study, Swelling attacks, Functional cure
Ocuphire Pharma Acquires Opus Genetics, Expanding into Inherited Retinal Disease Gene Therapies
Ocuphire Pharma, Opus Genetics, gene therapy, inherited retinal diseases (IRDs), merger, acquisition, biopharmaceutical, ophthalmic treatments
Sangamo Therapeutics Aligns with FDA on Accelerated Approval Pathway for ST-920 Gene Therapy in Fabry Disease
Sangamo Therapeutics, FDA, Accelerated Approval Pathway, ST-920, Fabry Disease, Gene Therapy, BLA Submission
Sangamo Therapeutics Fast-Tracks Fabry Gene Therapy with FDA Accelerated Approval Pathway
Sangamo Therapeutics, Fabry disease, gene therapy, isaralgagene civaparvovec, FDA, accelerated approval pathway, ST-920, STAAR study
Otsuka Seeks Accelerated Approval for Sibeprenlimab in IgA Nephropathy Following Positive Phase III Interim Results
Otsuka, sibeprenlimab, IgA nephropathy, Phase III trial, accelerated approval, FDA, kidney disease, autoimmune disease, APRIL antibody.