October 31, 2025 – Talk Bio

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

1 day 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

Wave Life Sciences Obesity Biomarker Data Raise Hopes for Future Readouts

1 day ago talkbio0Tagged Activin E :* *, Biological Markers, Body Composition, Clinical Trials, INHBE gene, INLIGHT trial, Obesity, RNA therapeutics, RNA, Small Interfering, Wave Life Sciences, Weight Loss, WVE-007

Wave Life Sciences; WVE-007; obesity; biomarker data; siRNA; Activin E; INHBE gene; RNA therapeutics; clinical trial; body composition; weight loss; INLIGHT trial

Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding PET-CT and Class II Medical Device Functionality

1 day ago talkbio0Tagged Advanced Imaging Suite, capabilities, Class II Medical Device, Clearance, image management, PET/CT scan, radiological imaging, regulatory approval, Sirona Medical, United States Food and Drug Administration

Sirona Medical; FDA 510(k) clearance; Advanced Imaging Suite; Radiological imaging; PET-CT capabilities; Class II medical device; image management; regulatory approval

ChemDiv’s Discovery Platform Enables Differentiated, Reversible Pan-EGFR Kinase Inhibitors for GFR-Mutant Lung Cancer

1 day ago talkbio0Tagged Candidiasis, Chronic Mucocutaneous, ChemDiv, Discovery Platform, Drug Design, Epidermal Growth Factor Receptor, Kinase Inhibitors [MoA], Kinome, lead-optimization, Non-Small Cell Lung Carcinoma, Pan-EGFR Inhibitors, Readiness, selectivity, Wild-Type EGFR Sparing

ChemDiv; Discovery Platform; EGFR; Reversible Pan-EGFR Inhibitors; NSCLC; Kinase Inhibitors; Wild-Type EGFR Sparing; Kinome Selectivity; AI-Guided Drug Design; CMC Readiness; Lead Optimization

Friday Five: Lilly Expands Zepbound’s DTC Reach, NVIDIA Powers Drug Discovery at Lilly and Verily, and OpenAI Advances Pharma AI Initiatives

1 day ago talkbio0Tagged AI supercomputer, direct-to-consumer ( DTC ), Drug Discovery, federated learning, LillyDirect, NVIDIA, OpenAI, Pharma AI, TuneLab, Walmart partnership, Zepbound

LillyDirect; Zepbound; Direct-to-consumer (DTC); NVIDIA; AI supercomputer; Verily; OpenAI; Pharma AI; Drug discovery; Walmart partnership; TuneLab; Federated learning

Altanine Strengthens Scientific Advisory Board with Appointment of Dr. Bruce D. Forrest

2 days ago talkbio0Tagged Altanine, biopharmaceutical development, Bruce D. Forrest, clinical strategy, Drug Delivery Systems, pharmaceutical innovation, Regulatory Expertise, Scientific Advisory Board, Vaccine Development

Altanine; Scientific Advisory Board; Bruce D. Forrest; drug delivery; clinical strategy; regulatory expertise; biopharmaceutical development; vaccine development; pharmaceutical innovation