Cell
Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial
Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation
Recent News on Scaling Up Cell & Gene Therapy Supply Chains (2025)
cell and gene therapy; supply chain; scalability; logistics; digital solutions; risk mitigation; white glove delivery; patient-specific therapies; automation; market growth
Vertex forges $2B-plus alliance with Enlaza to create new autoimmune drugs, improve conditioning methods
Vertex Pharmaceuticals; Enlaza Therapeutics; autoimmune diseases; gene therapy; conditioning regimens; War-Lock platform; covalent biologics; drug conjugates; T-cell engagers; biotech alliance
Gilead’s Kite to Acquire Interius for $350M, Advancing In Vivo CAR-T Therapy
Gilead; Kite; Interius BioTherapeutics; CAR-T therapy; in vivo CAR-T; acquisition; off-the-shelf cell therapy; $350 million; biotech; Yescarta; Tecartus; cell therapy platform
CytomX Continues Phase I ADC Study After Patient Death
CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation
Minghui Raises $131M to Advance PD-1xVEGF Bispecific Antibody Program
Minghui; Chinese biotech; PD-1xVEGF bispecific; fundraising; pre-IPO; ADC trials; JAK inhibitor; oncology; clinical development
FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders
FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry
NextCure Partners with Simcere for Novel ADC in $745M Deal
NextCure; Simcere; Antibody-Drug Conjugate; ADC; SIM0505; CDH6 Targeting
ADC Therapeutics Cuts 30% of Workforce, Closes UK R&D Site Amid Strategic Shift
ADC Therapeutics; layoffs; UK facility closure; biotech restructuring; R&D; antibody-drug conjugates; solid tumors; Zynlonta; preclinical programs
Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China
FDA; biotech; regulation; modernization; China; cell and gene therapy; CEO roundtable; competitiveness; innovation