Disease or Syndrome

2025 FDA staff cuts and their impact on new drug review timelines

4 hours ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

4 hours ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Parabilis raises $305M to advance Helicon peptide cancer drugs against ‘undruggable’ targets

8 hours ago talkbio0Tagged cancer drug development, Capital, Fibromatosis, Aggressive, fidelity, FOG-001, FogPharma, Helicon peptide platform, Janus Henderson, Malignant neoplasm of prostate, Parabilis Medicines, Rheumatoid Arthritis, Series F financing, targets, venture capital, zolucatetide

Parabilis Medicines; FogPharma; $305 million; Series F financing; undruggable targets; Helicon peptide platform; zolucatetide; FOG-001; desmoid tumors; prostate cancer; cancer drug development; venture capital; RA Capital; Fidelity; Janus Henderson

Lilly to acquire Ventyx Biosciences for ~$1.2B to add oral NLRP3 and other inflammatory drugs

13 hours ago talkbio0Tagged Acquisition, Autoimmune Diseases, cardiometabolic, Eli, Eli Lilly, Inflammatory disorder, Neuroinflammation, NLRP3 inhibitors, oral therapies, Ventyx Biosciences

Eli Lilly; Ventyx Biosciences; $1.2 billion; acquisition; NLRP3 inhibitors; VTX3232; VTX2735; inflammatory diseases; oral therapies; cardiometabolic; neuroinflammation; autoimmune diseases

Relation and Deerfield form NewCos to develop drugs from AI-discovered targets

13 hours ago talkbio0Tagged AI drug discovery, Bone Diseases, Deerfield Management, Drug Delivery Systems, Immunology, Lab-in-the-Loop, Metabolic Diseases, newco, Platform, Relative (related person), royalties, strategic collaboration

Relation; Deerfield Management; strategic collaboration; NewCo; AI drug discovery; Lab-in-the-Loop platform; novel therapeutics; immunology; metabolic disease; bone disease; drug targets; royalties

OpenAI launches ChatGPT Health as a dedicated, privacy-focused health assistant

1 day ago talkbio0Tagged Apple Health, b.well partnership, ChatGPT Health, DNA Integration, Health care facility, health data privacy, HealthBench, Healthcare AI, Medical Records, wellness apps * *

OpenAI; ChatGPT Health; healthcare AI; medical records integration; Apple Health; wellness apps; health data privacy; HealthBench; b.well partnership; AI in healthcare

Zaka VC Invests in DeepSeq.AI to Transform AI-Based Protein Drug Discovery

1 day ago talkbio0Tagged AI-based drug discovery, DARPA-funded initiative * *, datasets, DeepSeq, hyperscaled data, Illumina Ventures, Investments, LLM-based technology, prepulse inhibition activity, protein drug discovery, Vital capacity, Zaka

Zaka VC; DeepSeq.AI; protein drug discovery; AI-based drug discovery; hyperscaled data; LLM-based technology; biotech investment; DARPA-funded initiative; Illumina Ventures; PPI datasets

QuanBio Appoints Aubrey C. Galloway, MD, as Chief Medical Officer

1 day ago talkbio0Tagged AI-driven, Aubrey C. Galloway, Cardiothoracic surgery specialty, Chief Medical Officer, CMO appointment, Healthcare technology, Leadership Change, medical leadership, QuanBio, Vascular Diseases, vascular intelligence

QuanBio; Aubrey C. Galloway; Chief Medical Officer; CMO appointment; AI-driven vascular intelligence; cardiothoracic surgery; leadership change; healthcare technology; vascular disease; medical leadership