Research Activity – Page 5

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

3 weeks ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

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

3 weeks 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

Battle Intensifies in the Obesity Drug Market as Novo Nordisk and Eli Lilly Vie for Dominance

3 weeks ago talkbio0Tagged Benefit, Clinical Trials, competition, Compounders, Direct-to-Consumer, eli lilly, Glucagon-Like Peptide 1, manager, Market, Nordisk, Obesity, Pharmaceutical Services, Wegovy, Zepbound

obesity drugs; GLP-1; Wegovy; Zepbound; Novo Nordisk; Eli Lilly; market competition; direct-to-consumer; pharmacy benefit managers; compounders; clinical trials

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

3 weeks 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

Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success

3 weeks 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

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

4 weeks 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

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

4 weeks 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

CytomX Continues Phase I ADC Study After Patient Death

4 weeks ago talkbio0Tagged ADC, Clinical Trials, Colorectal Carcinoma, CX-2051, CytomX, Kidney Failure, Acute, Patient Death, Phase I, Safety, therapeutic autologous dendritic cells, United States Food and Drug Administration

CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation

NIH and HHS Cancel Major mRNA Vaccine Research Funding, Citing Lack of Public Trust

4 weeks ago talkbio0Tagged BARDA, COVID19 (disease), grant cancellation, Jay Bhattacharya, mRNA Vaccine, NIH Mouse, public trust, research funding, RFK Jr., Vaccination Hesitancy

NIH; mRNA vaccine; public trust; research funding; BARDA; COVID-19; vaccine hesitancy; RFK Jr.; Jay Bhattacharya; grant cancellation

Response Pharma: RDX-002 Limits Weight Regain After GLP-1 Therapy – Positive Phase II Results Announced

4 weeks ago talkbio0Tagged cardiometabolic health, Discontinuation (procedure), Glucagon-Like Peptide 1, iMTP, Inhibitor, Obesity, Phase 2 Clinical Trials, postprandial, RDX-002, Response process, Triglycerides, weight regain

Response Pharmaceuticals; RDX-002; GLP-1 discontinuation; weight regain; obesity; Phase II clinical trial; postprandial triglycerides; cardiometabolic health; iMTP inhibitor