Disease or Syndrome – Page 3

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

1 week ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

Aviceda’s AVD-104 misses Phase 2b primary endpoint vs Izervay but still headed to Phase 3

1 week ago talkbio0Tagged avacincaptad, AVD-104, Clinical trial failure, Clinical Trials, Dry AMD, Genus Aviceda, Geographic Atrophy, IZERVAY, pegol, Phase 3 prospects, Sialic Acid Binding Immunoglobulin-like Lectins

Aviceda; AVD-104; geographic atrophy; dry AMD; Phase 2b; SIGLEC trial; Izervay; avacincaptad pegol; clinical trial failure; Phase 3 prospects

Sobi Acquires Arthrosi Therapeutics for $950M Upfront in Gout Drug Deal

1 week ago talkbio0Tagged Acquisition, Arthrosi, Gout, pozdeutinurad, Sobi

Sobi; Arthrosi Therapeutics; acquisition; gout; pozdeutinurad; AR882

FDA approves new gonorrhea antibiotics from GSK and Innoviva

1 week ago talkbio0Tagged Antibiotic Resistance, Microbial, Approved, Blujepa, first-in-class antibiotic, gepotidacin, Gonorrhea, Gonorrhea genitourinary NOS, Innoviva, Nuzolvence, Oral treatment, SmithKline Beecham, Uncomplicated, United States Food and Drug Administration, zoliflodacin

gonorrhea; antibiotic resistance; GSK; Blujepa; gepotidacin; Innoviva; Nuzolvence; zoliflodacin; FDA approval; uncomplicated urogenital gonorrhea; first-in-class antibiotic; oral treatment

Innovent’s Mazdutide Shows Promising Obesity Data in Adolescents; No Everest PCSK9 News

2 weeks ago talkbio0Tagged Adolescent (age group), China, Innovent, mazdutide, Obesity, Phase 1b, Weight Loss

Innovent; mazdutide; obesity; adolescents; Phase 1b; weight loss; China

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

2 weeks ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

CDC highlights strong effectiveness of 2024–2025 COVID-19 shots in kids while FDA reviews reports of alleged post-vaccination deaths

2 weeks ago talkbio0Tagged alleged deaths, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Effectiveness, Emergency department patient visit, Pediatrics, safety review, United States Food and Drug Administration, urgent care visits, Vaccines, VAERS

CDC; FDA; COVID-19 vaccine; children; pediatrics; vaccine effectiveness; emergency department visits; urgent care visits; safety review; alleged deaths; VAERS

FDA Approves GSK’s Gepotidacin (Blujepa) for Uncomplicated Urogenital Gonorrhea

2 weeks ago talkbio0Tagged Antibiotics, Approved, Blujepa, gepotidacin, Gonorrhea, SmithKline Beecham, United States Food and Drug Administration

GSK; gepotidacin; Blujepa; FDA approval; gonorrhea; antibiotic

Rezolute Stock Crashes 90% After Phase 3 sunRIZE Trial Failure for Ersodetug in Hyperinsulinism

2 weeks ago talkbio0Tagged ersodetug, Hyperinsulinism, phase 3 failure, Rezolute, RZLT, Stock Crash

Rezolute; RZLT; ersodetug; Phase 3 failure; sunRIZE trial; stock crash; hyperinsulinism

Insilico Medicine and TaiGen sign exclusive licensing deal for AI-designed PHD inhibitor ISM4808 to treat anemia in chronic kidney disease

2 weeks ago talkbio0Tagged AI-driven, Anemia, CDE, China, Chronic Kidney Diseases, Clearance, clinical-stage biotech, Drug Discovery, Generative AI, Indonesian language, Insilico Medicine, ISM4808, License Agreement, Oral cavity, Ph.D., Pharma, PHD inhibitor, TaiGen Biotechnology

Insilico Medicine; TaiGen Biotechnology; license agreement; ISM4808; PHD inhibitor; anemia of Chronic Kidney Disease; CKD anemia; AI-driven drug discovery; Pharma.AI; Greater China rights; oral PHD inhibitor; IND clearance; China CDE; generative AI; clinical-stage biotech