Clinical Trials – Talk Bio

Patient Dies from Thrombotic Stroke in Pfizer’s Hympavzi Hemophilia Trial After Minor Surgery

2 days ago talkbio0Tagged Clinical Trials, Hemophilia A, HYMPAVZI, marstacimab, Patient Death, Pfizer, Thrombotic Stroke

Pfizer; Hympavzi; marstacimab; hemophilia; thrombotic stroke; patient death; clinical trial

FDA places partial clinical hold on Merck and Daiichi Sankyo’s I-DXd lung cancer trial after interstitial lung disease deaths

6 days ago talkbio0Tagged Antibody-Drug Conjugates, Clinical Trials, Daiichi, Deruxtecan, grade 5 ILD, I-DXd, IDeate-Lung02, ifinatamab, Lung Diseases, Interstitial, Merck, Partial, Sankyo, Small cell carcinoma of lung, United States Food and Drug Administration

FDA partial clinical hold; ifinatamab deruxtecan; I-DXd; IDeate-Lung02; Merck; Daiichi Sankyo; small cell lung cancer; interstitial lung disease; grade 5 ILD; antibody-drug conjugate; clinical trial deaths

Ipsen’s Fidrisertib Fails Primary Endpoint in Pivotal Phase II FALKON Trial for Rare Bone Disease FOP

7 days ago talkbio0Tagged Clinical Trials, FALKON, Fibrodysplasia Ossificans Progressiva, fidrisertib, Heterotopic Ossification, Ipsen, Phase II Failure

Ipsen; fidrisertib; FALKON trial; FOP; Phase II failure; heterotopic ossification

Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study

7 days ago talkbio0Tagged Approved, Clinical Trials, Eli, Glucagon-Like Peptide 1, injectable incretins, national priority review voucher, Obesity, Oral cavity, orforglipron, Phase 3 trial, United States Food and Drug Administration, Wegovy, weight maintenance, Zepbound

Eli Lilly; orforglipron; oral GLP-1; FDA approval; national priority review voucher; ATTAIN-MAINTAIN trial; obesity treatment; weight maintenance; Zepbound; Wegovy; injectable incretins; Phase 3 trial

Models are out, molecules are in as AI drug startups sprint to the clinic

1 week ago talkbio0Tagged Absci, AI drug discovery, AI-designed molecules, Clinical Trials, clinical-stage AI startups, Funding, Insilico Medicine, PsiThera, Recursion Pharmaceuticals, small molecule therapeutics

AI drug discovery; AI-designed molecules; clinical-stage AI startups; small-molecule therapeutics; biotech funding; Insilico Medicine; Recursion Pharmaceuticals; Absci; PsiThera; clinical trials

Harbour BioMed inks $90M upfront, $1B+ antibody alliance with Bristol Myers Squibb

1 week ago talkbio0Tagged biobucks, Burning Mouth Syndrome, China, Clinical Trials, global strategic collaboration, Harbour BioMed, Harbour Mice ® technology, Immunology, License Agreement, milestones, multi-specific antibodies, Myers Squibb, Neoplasms

Harbour BioMed; Bristol Myers Squibb; BMS; multi-specific antibodies; $90 million upfront; $1.035 billion milestones; global strategic collaboration; license agreement; Harbour Mice technology; immunology; oncology; biobucks deal; China early clinical trials

China’s fast, low-cost gene and cell therapy testing boom draws Western interest

1 week ago talkbio0Tagged Advanced Therapy Medicinal Products, ATMP regulation China, CDE, Cell Therapy, China, clinical trial review, Clinical Trials, gene therapy, N-methyl-N-2-(methylsulfinyl)ethylpropionic acid amide, reforms, Shortened, therapies testing, Western biotech

China clinical trials; gene therapy; cell therapy; advanced therapy medicinal products; ATMP regulation China 2025; shortened clinical trial review; cheap clinical trials; Western biotech in China; NMPA CDE reforms; novel therapies testing

Aviceda’s AVD-104 misses Phase 2b primary endpoint vs Izervay but still headed to Phase 3

1 week ago talkbio0Tagged avacincaptad, AVD-104, Clinical trial failure, Clinical Trials, Dry AMD, Genus Aviceda, Geographic Atrophy, IZERVAY, pegol, Phase 3 prospects, Sialic Acid Binding Immunoglobulin-like Lectins

Aviceda; AVD-104; geographic atrophy; dry AMD; Phase 2b; SIGLEC trial; Izervay; avacincaptad pegol; clinical trial failure; Phase 3 prospects

Scaling for a New Era: The Rise of Radiopharma

1 week ago talkbio0Tagged Clinical Trials, CROs, Diagnostics, Funding, Lutetium-177, M&A, Neoplasms, Pet Animal, precision oncology, radioligand therapy, Radiopharmaceuticals, radiotheranostics, Research Infrastructure, supply chain, targeted alpha therapy

radiopharmaceuticals; radioligand therapy; oncology; precision oncology; targeted alpha therapy; Lutetium-177; Actinium-225; clinical trials; radiotheranostics; M&A; biotech funding; supply chain; infrastructure; CROs; companion diagnostics

Image Analysis Group Partners with Better Medicine for AI-Driven Oncology Clinical Trial Imaging

2 weeks ago talkbio0Tagged AI oncology imaging, central reads, Clinical Trials, DYNAMIKA, Image Analysis Group

Image Analysis Group; Better Medicine; AI oncology imaging; clinical trials; DYNAMIKA; central reads