Human-caused Phenomenon or Process

Acrivon Therapeutics Showcases AP3 Platform and Preclinical Data for ACR-2316 with Three Poster Presentations at AACR-NCI-EORTC 2025

3 days ago talkbio0Tagged ACR-2316, Acrivon, AP3, Conferences, Generative Phosphoproteomics, Inhibitor, KaiSR, partial response, PKMYT1 protein, human, Platform, PLK1 gene, precision oncology, preclinical data, Study models, WEE1 inhibitor

Acrivon Therapeutics; AP3 platform; Generative Phosphoproteomics; KaiSR model; ACR-2316; AACR-NCI-EORTC conference; preclinical data; partial response; WEE1 inhibitor; PKMYT1 inhibitor; PLK1; precision oncology

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

2 weeks 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

1 month 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

Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

1 month ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

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

2 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

2 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

2 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

3 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

3 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

GSK set to receive over $500M from mRNA patent settlement tied to BioNTech–CureVac–Pfizer deal

3 months ago talkbio0Tagged BioNTech, BioNTech acquisition, COVID19 (disease), CureVac, global framework, Influenza virus vaccine, Licensing, Litigation, Pfizer, RNA, Messenger, royalties, settlement, SmithKline Beecham, U.S., upfront payment, Vaccines, Vaccines, Combined

GSK; CureVac; BioNTech; Pfizer; mRNA patents; settlement; royalties; COVID-19 vaccine; influenza vaccine; combination vaccines; licensing; upfront payment; US litigation; global framework; BioNTech acquisition of CureVac