Safety – Talk Bio

AI-Designed Drug AH-001 Completes U.S. Phase I Trial, Demonstrating Excellent Safety and Tolerability

4 weeks ago talkbio0Tagged AH 001, AI-designed drug, Alopecia, Androgenetic Alopecia, AnHorn Medicines, Generative AI, Phase I Clinical Trials, protein degrader, Safety, tolerability

AH-001; AI-designed drug; Phase I clinical trial; safety; tolerability; androgenetic alopecia; protein degrader; AnHorn Medicines; generative AI; hair loss

Intellia Pauses Two CRISPR Trials After Severe Liver Toxicity Hospitalizes Patient

4 weeks 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

Halda’s HLD-0915 Shows Promising First-in-Human Results as a Safer RIPTAC Cancer Therapeutic

1 month ago talkbio0Tagged anti-tumor activity, first-in-human, Halda Therapeutics, HLD-0915, Metastatic castration-resistant prostate cancer, Oral cavity, RIPTAC, Safety

Halda Therapeutics; HLD-0915; RIPTAC; metastatic castration-resistant prostate cancer; first-in-human; safety; anti-tumor activity; oral therapeutic

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

1 month ago talkbio0Tagged ACHIEVE-1, ATTAIN-2, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Effectiveness, Eli Lilly, Farxiga, Glucagon-Like Peptide 1, Oral cavity, orforglipron, regulatory submission, Safety, semaglutide, Weight Loss

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

3 months ago talkbio0Tagged Clinical Trials, concerns, Drug withdrawal syndrome, Injury of liver, Intercept Pharmaceuticals, Liver diseases, Ocaliva, Primary Biliary Cholangitis, regulatory setbacks, Safety, United States Food and Drug Administration

Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks

Amgen, Kyowa Kirin Bolster Safety Profile for Atopic Dermatitis Drug Rocatinlimab

3 months ago talkbio0Tagged amgen, ASCEND trial, Dermatitis, Atopic, Eczema, Kyowa Kirin, Long-term, OX40 receptor, Programs - Publication Format, Rocatinlimab, Rocket, Safety

Amgen; Kyowa Kirin; rocatinlimab; atopic dermatitis; OX40 receptor; ASCEND trial; ROCKET program; long-term safety; eczema

FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns

3 months ago talkbio0Tagged Adverse event, Cessation of life, chikungunya vaccine, Encephalitis, Hospitalization, Ixchiq, license suspension, Safety, United States Food and Drug Administration, Valneva

FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths

CytomX Continues Phase I ADC Study After Patient Death

3 months ago talkbio0Tagged ADC, Clinical Trials, Colorectal Carcinoma, CX-2051, CytomX, Kidney Failure, Acute, Patient Death, Phase I, Safety, therapeutic autologous dendritic cells, United States Food and Drug Administration

CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation

FDA restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges

4 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Donor person, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA Match, label update, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; eli-cel; cerebral adrenoleukodystrophy; CALD; hematologic malignancies; myelodysplastic syndrome (MDS); acute myeloid leukemia (AML); boxed warning; label update; postmarketing safety; HLA-matched donor; gene therapy safety

FDA tightens Skysona label, restricting use to CALD patients without alternative options due to increased blood cancer risk

4 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA‑matched donor, labeling changes, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; labeling changes; boxed warning; hematologic malignancy; myelodysplastic syndrome; acute myeloid leukemia; cerebral adrenoleukodystrophy; CALD; HLA‑matched donor; gene therapy safety; post‑marketing reports