June 12, 2025 – Talk Bio

BioNTech to Acquire CureVac in $1.25B All-Stock mRNA Deal

2 days ago talkbio0Tagged Acquisition, all-stock, BioNTech, Biotechnology, Cancer Therapeutic Procedure, COVID-19 Vaccines, CureVac, Germany, mRNA Vaccines, Neoplasms

BioNTech; CureVac; acquisition; mRNA vaccines; cancer treatment; all-stock deal; Germany; biotechnology; oncology; COVID-19 vaccine

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

2 days ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

FDA Launches AI Tool to Accelerate and Transform Drug Review Processes

2 days ago talkbio0Tagged AI tool, application assessment, Automation, drug review, Elsa, Generative AI, regulatory science, United States Food and Drug Administration

FDA; AI tool; drug review; rapid review; generative AI; regulatory science; Elsa; automation; application assessment

Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

2 days ago talkbio0Tagged Approved, Bio, IBTROZI, Malignant neoplasm of lung, Nuvation, Oral treatment, Protein-tyrosine kinase inhibitor, ROS1-positive NSCLC, taletrectinib, United States Food and Drug Administration

Nuvation Bio; FDA approval; Ibtrozi; taletrectinib; lung cancer; ROS1-positive NSCLC; oral treatment; tyrosine kinase inhibitor

NVIDIA and Novo Nordisk Partner to Accelerate AI-Driven Drug Discovery

2 days ago talkbio0Tagged AI models, Artificial Intelligence, BioNeMo, Drug Discovery, Gefion AI Supercomputer, Nordisk, NVIDIA, Omniverse, pharmaceutical innovation

NVIDIA; Novo Nordisk; AI models; drug discovery; Gefion AI Supercomputer; BioNeMo; Omniverse; pharmaceutical innovation

Genentech Lays Off 143 Employees as Part of Ongoing Cuts by Roche in Bay Area

2 days ago talkbio0Tagged Aortic Valve Insufficiency, Bay Area, biotech industry, Dosage Forms, genentech, layoffs, Roche (company), South San Francisco, WARN filing

Genentech; Roche; layoffs; South San Francisco; biotech job cuts; Bay Area; AI strategy; WARN filing; pharmaceutical; biotech industry

FDA Leaders Anticipate Imminent Drug Approval Decisions

2 days ago talkbio0Tagged approvals, Drug Approval, Leadership, PDUFA, regulatory decision, United States Food and Drug Administration

FDA; drug approval; PDUFA date; regulatory decision; upcoming approvals; FDA leadership

Novo Nordisk Signs $812M Deal with Deep Apple to Develop Non-Incretin Obesity Drugs

2 days ago talkbio0Tagged cardiometabolic disease, Deep Apple, Drug Discovery, G-Protein-Coupled Receptors, Non-Incretin, Nordisk, Obesity, research collaboration, Small Molecule

Novo Nordisk; Deep Apple Therapeutics; obesity; non-incretin; GPCR; cardiometabolic disease; small molecules; research collaboration; deal; drug discovery