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

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

Moderna Lands CEPI as New Backer for Its Pandemic Flu (H5 Bird Flu) Program

Moderna; CEPI; Coalition for Epidemic Preparedness Innovations; pandemic influenza; H5 bird flu; mRNA vaccine; Phase 3 trial; pandemic preparedness; vaccine development; funding

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

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

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

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

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