November 13, 2025

Zealand Pharma Pauses Development of GLP-1/GLP-2 Dual Agonist Dapiglutide for Obesity

11 hours ago talkbio0Tagged Agonist, Clinical Development, Dapiglutide, drug market, GLP-1/GLP-2, Obesity, obesity therapy, petrelintide, pipeline management, Zealand Pharma

Zealand Pharma; dapiglutide; GLP-1/GLP-2 dual agonist; obesity therapy; clinical development; obesity drug market; pipeline management; petrelintide; survodutide

Korro Bio Abandons Lead Genetic Disease Drug Candidate KRRO-110 After Disappointing Trial Data

11 hours ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical trial failure, GalNAc, Korro Bio, KRRO-110, layoffs, Nordisk, Partnership, Platform, RNA Editing

Korro Bio; KRRO-110; Alpha-1 Antitrypsin Deficiency (AATD); RNA editing; clinical trial failure; layoffs; Novo Nordisk partnership; GalNAc platform; biotech strategy shift

Chinese Biotechs Shed Fast-Follower Reputations as Innovation Surges in 2025

13 hours ago talkbio0Tagged Biopharma, China, Chinese Language, Clinical Trials, drug candidates, global drug pipeline, innovation, leader, R&D, regulatory reforms

Chinese biotech innovation; fast-follower to leader; biopharma R&D; global drug pipeline; regulatory reforms; clinical trials; Made in China 2025; novel drug candidates

Alkermes Pushes Narcolepsy Program to Phase III With Highly Competitive Mid-Stage Data

14 hours ago talkbio0Tagged alixorexton, Alkermes, clinical endpoints, Narcolepsy, Orexin Receptor Agonist, Phase 2 Clinical Trials, Phase 3 Clinical Trials, Sleep Disorders, Wakefulness

Alkermes; alixorexton; narcolepsy; Phase II trial; Phase III clinical trial; orexin 2 receptor agonist; wakefulness; sleep disorder; clinical endpoints

FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

14 hours ago talkbio0Tagged Center for Drug Evaluation, Center for Drug Evaluation and Research, Drug Approval, George Tidmarsh, leadership instability, OCE, Oncology Center of Excellence, Project, regulatory reform, research, review delays, Richard Pazdur, United States Food and Drug Administration

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

Bayer’s Pharma Division Grows as Restructuring Drives Major Changes

19 hours 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

19 hours 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

19 hours 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

21 hours 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

1 day 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