Finding – Page 2

Second Patient Dies After Receiving Sarepta’s Elevidys Gene Therapy for DMD

1 month ago talkbio0Tagged AAV-based gene therapy, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Patient Death, risk mitigation, Unable to walk (finding), United States Food and Drug Administration

Duchenne muscular dystrophy; gene therapy; Sarepta Therapeutics; Elevidys; acute liver failure; AAV-based gene therapy; patient death; non-ambulatory patients; FDA; risk mitigation

Sarepta Halts Duchenne Gene Therapy in Some Patients After Second Death

1 month ago talkbio0Tagged Clinical Trials, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient safety, Therapeutic immunosuppression, Unable to walk (finding), United States Food and Drug Administration

Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; Elevidys; acute liver failure; non-ambulatory patients; FDA; clinical trial pause; immunosuppression; patient safety

Lilly Posts Encouraging Early-Stage Weight Loss Data on Amylin Candidate

1 month ago talkbio0Tagged Amylin Candidate, aspects of adverse effects, Clinical Data, early-stage trial, Eli, Eli Lilly, Eloralintide, Obesity, Weight Loss

Eli Lilly; eloralintide; amylin candidate; weight loss; early-stage trial; obesity drug; clinical data; side effects

Novo Nordisk Plans Phase 3 Trials for Next-Generation Obesity Drug Amycretin

1 month ago talkbio0Tagged amycretin, Clinical Trials, Glucagon-Like Peptide 1, Nordisk, Obesity, Oral cavity, Phase 3, Receptors, Islet Amyloid Polypeptide, subcutaneous, Weight Loss

Novo Nordisk; amycretin; obesity; clinical trials; Phase 3; GLP-1; amylin receptor; weight loss; subcutaneous; oral

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

1 month ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results

1 month ago talkbio0Tagged Clinical Trials, Engaged to be married, Insmed, PAH, Phase 3 Clinical Trials, Pulmonary arterial hypertension, TPTE2 gene, treprostinil palmitil inhalation powder, United States Food and Drug Administration

Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement

Otsuka’s Phase 3 IgAN Win with Sibeprenlimab Shakes Vera’s Stock

2 months ago talkbio0Tagged IGA Glomerulonephritis, Kidney Diseases, Otsuka, Priority Review, Proteinuria, Sibeprenlimab, stock drop, United States Food and Drug Administration, UPCR, vera

Otsuka; sibeprenlimab; IgA nephropathy; phase 3 trial; proteinuria reduction; Vera Therapeutics; stock drop; kidney disease; UPCR; FDA Priority Review

Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study

2 months ago talkbio0Tagged Acne Vulgaris, Ascletis, Biosciences, Chinese study, clinical endpoints, Clinical Trials, Denifanstat, Inhibitor, Lesion, oral FASN, Phase 3, Sagimet

Ascletis; Sagimet Biosciences; denifanstat; oral FASN inhibitor; phase 3 clinical trial; acne vulgaris; clinical endpoints; lesion reduction; Chinese study

Science-Led Storytelling Takes Center Stage in Pharma Communications (June 2025)

2 months ago talkbio0Tagged Cheryl Lubbert, Engaged to be married, Pharma, pharmaceutical communications, Reverba Global, science-led storytelling, Translucent, Trust (Social Behavior)

pharmaceutical communications; science-led storytelling; pharma marketing; patient engagement; trust and transparency; Cheryl Lubbert; Reverba Global

Eli Lilly Expands RNA Pipeline with $1.3 Billion Rznomics Hearing Loss Pact

2 months ago talkbio0Tagged Deafness, Eli, Eli Lilly, gene therapy, pharmaceutical partnerships, RNA Editing, RNA therapeutics, Rznomics, Sensorineural Hearing Loss (disorder), trans-splicing ribozyme

Eli Lilly; Rznomics; RNA editing; hearing loss; gene therapy; pharmaceutical partnerships; biotech; trans-splicing ribozyme; sensorineural hearing loss; RNA therapeutics