talkbio – Page 3

VantAI and Halda Strike $1B+ AI-Driven Partnership on ‘Hold-and-Kill’ Drugs

4 days ago talkbio0Tagged Aortic Valve Insufficiency, cellular targeting, Chimera organism, Drug Discovery, Halda Therapeutics, hold-and-kill, Immunology, Induce (action), Neoplasms, Proximity, RIPTAC, target-effector pairs, VantAI

VantAI; Halda Therapeutics; RIPTAC drugs; hold-and-kill; AI drug discovery; target-effector pairs; oncology; immunology; regulated induced proximity targeting chimeras; $1 billion deal

FDA Extends PDUFA Date for Regenxbio’s Hunter Syndrome Gene Therapy RGX-121

4 days ago talkbio0Tagged clemidsogene lanparvovec, Deferred, gene therapy, IDS gene, Infrequent, Mucopolysaccharidosis II, PDUFA, Regenxbio, RGX-121, United States Food and Drug Administration

FDA delay; PDUFA extension; Regenxbio; Hunter syndrome; clemidsogene lanparvovec; RGX-121; gene therapy; Mucopolysaccharidosis II; IDS gene; rare disease

Merck KGaA and Skyhawk Therapeutics Launch $2B RNA-Targeting Neurology Collaboration

4 days ago talkbio0Tagged Billion Collaboration, Drug Development, Merck KGaA, milestone payments, nervous system disorder, RNA-targeting, royalties, Skyhawk, SkySTAR platform

Merck KGaA; Skyhawk Therapeutics; RNA-targeting; SkySTAR platform; neurological disorders; $2 billion collaboration; drug development; milestone payments; royalties

Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success

4 days ago talkbio0Tagged Clinical Trials, Depression, Postpartum, Montgomery-Åsberg Depression Rating Scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Neuroscience discipline, Phase 2 Clinical Trials, Phase 3 Clinical Trials, psychedelic therapy, RE104, RECONNECT, remission rates, Reunion

Reunion Neuroscience; RE104; psychedelic therapy; postpartum depression (PPD); Phase II trial; Phase III trial; RECONNECT trial; clinical trial results; Montgomery-Åsberg Depression Rating Scale (MADRS); remission rates

Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

4 days ago talkbio0Tagged Clinical Trials, Evidence, Federal Appeals Court, Hetlioz, jet lag disorder, New Drug Application, regulatory law, sNDA, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence

Conflicts of Interest Among Federal Vaccine Advisors at Historic Lows Through 2024

5 days ago talkbio0Tagged ACIP, Advisory Committees, Centers for Disease Control and Prevention (U.S.), JAMA study, Robert F. Kennedy Jr., Translucent, United States Food and Drug Administration, Vaccines, VRBPAC

conflicts of interest; vaccine advisory committees; ACIP; VRBPAC; CDC; FDA; transparency; Robert F. Kennedy Jr.; JAMA study

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

5 days ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

FDA Grants Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring

5 days ago talkbio0Tagged Accelerated, Approved, Fibrosis, Liver, MASH, noncirrhotic, Nordisk, Product containing glucagon-like peptide 1 receptor agonist (product), semaglutide, United States Food and Drug Administration, Wegovy

Wegovy; FDA approval; MASH; semaglutide; GLP-1 receptor agonist; liver fibrosis; Novo Nordisk; ESSENCE trial; noncirrhotic; accelerated approval

Merck KGaA Forms $2 Billion Neurological Disease Pact with Skyhawk Therapeutics

5 days ago talkbio0Tagged Drug Discovery, Merck KGaA, milestone payments, Neurological diseases, RNA Splicing, Skyhawk, SkySTAR platform, strategic collaboration

Merck KGaA; Skyhawk Therapeutics; neurological diseases; RNA splicing; SkySTAR platform; drug discovery; strategic collaboration; milestone payments

Genentech to End $2B Cell Therapy Collaboration with Adaptive Biotechnologies

5 days ago talkbio0Tagged Adaptive Biotechnologies, Cell Therapy, Collaboration termination, genentech, personalized cancer, T-Cell Receptor, TruTCR

Genentech; Adaptive Biotechnologies; cell therapy; collaboration termination; T-cell receptor; TruTCR platform; personalized cancer therapy; $2 billion deal