Toxicity aspects – Talk Bio

Patient Hospitalized After Receiving Intellia’s CRISPR Therapy Dies, Prompting FDA Hold on Trials

3 weeks ago talkbio0Tagged Amyloidosis, Clinical Trials, Comorbidity, CRISPR therapy, Intellia, Liver, nex-z, nexiguran ziclumeran, Patient Death, Phase III MAGNITUDE trial, Toxicity aspects, TTR wt Allele, United States Food and Drug Administration

Intellia Therapeutics; CRISPR therapy; nexiguran ziclumeran (nex-z); patient death; liver toxicity; Phase III MAGNITUDE trial; ATTR amyloidosis; clinical trial hold; FDA; comorbidities

FDA Places Clinical Hold on Two Intellia CRISPR Trials After Life-Threatening Liver Toxicity Case

4 weeks ago talkbio0Tagged ATTR-CM, ATTR-PN, Clustered Regularly Interspaced Short Palindromic Repeats, gene therapy, Intellia, Liver, MAGNITUDE trial, Nexiguran, Senile cardiac amyloidosis, Study on Hold, Toxicity aspects, United States Food and Drug Administration, ziclumeran

FDA; Intellia; CRISPR; clinical hold; liver toxicity; nexiguran ziclumeran; MAGNITUDE trial; transthyretin amyloidosis; ATTR-CM; ATTR-PN; gene therapy

Intellia Pauses Two CRISPR Trials After Severe Liver Toxicity Hospitalizes Patient

1 month ago talkbio0Tagged Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, Hospitalization, Intellia, Liver, Pauses, Phase 3 Clinical Trials, Safety, Senile cardiac amyloidosis, Toxicity aspects

Intellia Therapeutics; CRISPR; transthyretin amyloidosis; Phase III trials; gene editing; liver toxicity; patient hospitalization; safety pause

Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

1 month ago talkbio0Tagged Anti-DR5 Agonistic Monoclonal Antibody INBRX-109, Biological Factors, Chondrosarcoma, Infrequent, Inhibrx, Liver, Malignant Bone Neoplasm, Malignant Neoplasms, ozekibart, Progression-Free Survival, Receptors, Tumor Necrosis Factor, Member 10b, Submission, Toxicity aspects, United States Food and Drug Administration

Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity

ESMO Spotlight: Flagship ADCs move into early-stage cancer to validate chemo-displacement ambitions

1 month ago talkbio0Tagged 2025, ADCs, Administration occupational activities, Antibody-Drug Conjugates, Biological Markers, chemo-displacement, Datopotamab deruxtecan, Datroway, Enhertu, ESMO, HER2-positive, Limited stage (cancer stage), Malignant neoplasm of breast, Toxicity aspects, trastuzumab, Triple Negative Breast Neoplasms

ESMO 2025; antibody-drug conjugates; ADCs; early-stage cancer; chemo-displacement; trastuzumab deruxtecan; ENHERTU; datopotamab deruxtecan; DATROWAY; breast cancer; HER2-positive; triple-negative breast cancer; biomarkers; toxicity management

Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile

3 months ago talkbio0Tagged benefit-risk profile, Clinical Trials, Dose-Limiting, Drug Development, Malignant Neoplasms, mesothelin, T-Cell engager, Toxicity aspects, ZW171, Zymeworks

Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

5 months ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

5 months ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

5 months ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

FDA puts Vyne in a twist, slapping hold on psoriasis trial over testicular toxicity concerns

7 months ago talkbio0Tagged Study on Hold, Testiculo-, Toxicity aspects, United States Food and Drug Administration, Vyne

Vyne, United States Food and Drug Administration, Testiculo-, Toxicity aspects, Study on Hold, United States Food and Drug Administration