Research Activity

FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys

22 hours ago talkbio0Tagged approval status, CBER, concerns, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, Pauses, Safety, Scientific Study, shipment, United States Food and Drug Administration

Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status

AstraZeneca’s Self-Administered Myasthenia Gravis Drug Gefurulimab Clears Phase 3 Trial

2 days ago talkbio0Tagged Acquisition, Alexion, AstraZeneca, Autoimmune Diseases, C5 inhibitor, Clinical Trials, Gefurulimab, Myasthenia Gravis, PREVAIL trial, self-administered drug

AstraZeneca; gefurulimab; myasthenia gravis; self-administered drug; Phase 3 trial; PREVAIL trial; C5 inhibitor; autoimmune disease; clinical trial; Alexion acquisition

Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

2 days ago talkbio0Tagged AD109, Apnimed, aroxybutynin, atomoxetine, Clinical Trials, LunAIRo, oral drug, Sleep Apnea, Obstructive, Submission, SynAIRgy, United States Food and Drug Administration

Apnimed; AD109; obstructive sleep apnea; OSA; oral drug; phase 3 trial; LunAIRo; SynAIRgy; FDA submission; clinical trial; aroxybutynin; atomoxetine

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

3 days ago talkbio0Tagged Blood - brain barrier anatomy, CorestemChemon, Drug Discovery, FDA/EMA regulatory pathways, Gene Expression Profiling, heart organoids, Lifetech, liver organoids, lymphocyte immune globulin, anti-thymocyte globulin, Organoids, preclinical CRO, Predictive analytics, Tumorigenicity

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models

Scancell’s Cancer Vaccine Supercharges Melanoma Immunotherapy in Recent Trials

3 days ago talkbio0Tagged Cancer Vaccines, checkpoint inhibitors, Clinical Trials, Immunotherapy, iSCIB1 +, melanoma, Melanoma TRP2 CTL Epitope Vaccine SCIB1, Scancell, SCOPE trial

Scancell; SCIB1; iSCIB1+; melanoma; cancer vaccine; immunotherapy; checkpoint inhibitors; clinical trial; SCOPE trial

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

4 days ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings