talkbio – Page 13

Bayer’s Pharma Division Grows as Restructuring Drives Major Changes

3 weeks ago talkbio0Tagged Administration occupational activities, Bayer, DSO, Dynamic Shared Ownership, Kerendia, Neoplasms, Nubeqa, pharma division, restructuring, Sales growth, Xarelto

Bayer; pharma division; restructuring; job cuts; Dynamic Shared Ownership (DSO); sales growth; oncology; Kerendia; Nubeqa; Xarelto; management changes

Major Leadership Changes and Fundraising in Biotech: Metagenomi CEO Exit, Workforce Cuts; Cogent Biosciences Raises Over $475M

3 weeks ago talkbio0Tagged bezuclastinib, Brian Thomas, CEO, Cogent Biosciences, Exit, Fund Raising, hemophilia A program, Irish (ethnic group), Jian, layoffs, Metagenomi, pipeline focus, Workforce

Metagenomi; CEO exit; Brian Thomas; Jian Irish; workforce cuts; biotech layoffs; Cogent Biosciences; fundraising; bezuclastinib; hemophilia A program; pipeline focus

FDA Unveils ‘Plausible Mechanism Pathway’ to Accelerate Personalized Therapies, Inspired by Baby KJ

3 weeks ago talkbio0Tagged Baby KJ, Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, Infrequent, mechanism pathway, personalized therapies, regulatory innovation, United States Food and Drug Administration

FDA; personalized therapies; gene editing; plausible mechanism pathway; Baby KJ; rare diseases; CRISPR; regulatory innovation

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA Plan, Launching Its Hyper-Precise Aortic Care Platform

3 weeks ago talkbio0Tagged AiORTA, Anatomical segmentation, Aortic Aneurysm, automated aortic surgery, Clearance, Clinical, cloud-based healthcare, hyper-precise aortic care, Infantile Neuroaxonal Dystrophy, measurement automation, Medical service, Preoperative, United States Food and Drug Administration, vascular AI, ViTAA, workflow improvement

ViTAA Medical; FDA 510(k) clearance; AiORTA Plan; hyper-precise aortic care; automated aortic surgery planning; vascular AI; preoperative measurement automation; cloud-based healthcare; aortic aneurysm segmentation; clinical workflow improvement

Merck Q3 2025: Solid Organic Growth Across All Sectors

3 weeks ago talkbio0Tagged Acquisition, Animal Health, Gross margin, Keytruda, Merck, Neoplasms, new product, organic growth, Pharma, Q3 2025, Verona

Merck; Q3 2025; Organic growth; KEYTRUDA; Oncology; Animal Health; Verona Pharma acquisition; Gross margin; Revenue; New product launches

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

3 weeks ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis

Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development

3 weeks ago talkbio0Tagged Autoimmune Diseases, Biological Factors, Dennis Dean, Drug Development, executive vice president, Head of Non-Clinical Development, Odyssey Therapeutics, preclinical research

Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical

Neurocrine’s Phase 2 Depression Drug Fails Primary Endpoint in Major Takeda-Licensed Study

3 weeks ago talkbio0Tagged Biosciences, Clinical Trials, depression drug, Depressive disorder, Drug licensing, NBI-1070770, Neurocrine, pharmaceutical setbacks, Phase 2 Failure, psychiatry pipeline, Takeda

Neurocrine Biosciences; Takeda; NBI-1070770; Phase 2 failure; major depressive disorder; depression drug; psychiatry pipeline; clinical trial results; drug licensing; pharmaceutical setbacks

FDA Moves to Remove Black Box Warnings from Menopausal Hormone Therapies

3 weeks ago talkbio0Tagged Black Box Warning, estrogens, Hormone replacement therapy, Hormone Therapy, labeling change, Menopausal symptom, Menopause, Progestins, United States Food and Drug Administration, women 's health

FDA; menopause; hormone therapy; black box warning; HRT; estrogen; progestogen; labeling change; women’s health; menopausal symptoms

Voyager Therapeutics Partners with Transition Bio for Small Molecule Neurodegenerative Drug Discovery; CRISPR Therapeutics Ends Work on CAR-T Therapy

3 weeks ago talkbio0Tagged Amyotrophic Lateral Sclerosis, CAR-T therapy, Clustered Regularly Interspaced Short Palindromic Repeats, Drug Development, Neurodegenerative Disorders, Partnership, Pick Disease of the Brain, small molecule drug discovery, TARDBP gene, Transition Bio, Voyager Therapeutics

Voyager Therapeutics; Transition Bio; ALS; frontotemporal dementia; TDP-43; small molecule drug discovery; neurodegenerative diseases; CRISPR Therapeutics; CAR-T therapy; partnership; drug development