Organism Attribute

GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)

1 month ago talkbio0Tagged Approved, Asthma, biology (field), Depemokimab, dosing, eosinophilic, Exdensur, IL-5 Inhibitor, Phenotype, Severe (severity modifier), SmithKline Beecham, twice-yearly, type 2 inflammation, ultra-long acting, United States Food and Drug Administration

GSK; Exdensur; depemokimab; FDA approval; severe asthma; ultra-long-acting biologic; twice-yearly dosing; type 2 inflammation; eosinophilic phenotype; IL-5 inhibitor

FDA approves new gonorrhea antibiotics from GSK and Innoviva

1 month 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

Diamyd Medical’s Pivotal Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of Early Readout in March 2026

2 months ago talkbio0Tagged Accelerated, approval pathway, Data Safety, Diabetes Mellitus, Insulin-Dependent, DIAGNODE-3, Diamyd Medical, DSMB, fast-track designation, Genotype, HLA DR3-DQ2, interim readout, Monitoring Board, orphan drug designation, Phase 3 trial, precision therapy, safety review

Diamyd Medical; Type 1 Diabetes; Phase 3 trial; DIAGNODE-3; safety review; Data Safety Monitoring Board (DSMB); interim readout; March 2026; HLA DR3-DQ2 genotype; Orphan Drug Designation; Fast Track Designation; accelerated approval pathway; precision therapy

Wave Life Sciences Obesity Biomarker Data Raise Hopes for Future Readouts

3 months ago talkbio0Tagged Activin E :* *, Biological Markers, Body Composition, Clinical Trials, INHBE gene, INLIGHT trial, Obesity, RNA therapeutics, RNA, Small Interfering, Wave Life Sciences, Weight Loss, WVE-007

Wave Life Sciences; WVE-007; obesity; biomarker data; siRNA; Activin E; INHBE gene; RNA therapeutics; clinical trial; body composition; weight loss; INLIGHT trial

UK Proposes Raising Payment Scheme for Branded Medicines to Nearly 25% Amid Industry Pushback

4 months ago talkbio0Tagged Consultation, drugmakers, Industry, Nance-Horan syndrome, payment, pharmaceutical rebates, Pricing, Response process, spending, statutory scheme, UK

UK medicine pricing; NHS spending; statutory scheme; drugmakers; payment percentage; pharmaceutical rebates; industry response; consultation 2025

MoonLake shares crash after mixed results in pivotal hidradenitis suppurativa studies

4 months ago talkbio0Tagged Bimzelx, Clinical Trials, Cosentyx, drug approval outlook, drug market, Hidradenitis Suppurativa, inhibitors, Interleukin-17, MoonLake Immunotherapeutics, Placebos, Response process, sonelokimab

MoonLake Immunotherapeutics; Sonelokimab; hidradenitis suppurativa; Phase 3 trial; clinical trial results; biotech shares; placebo response; drug approval outlook; IL-17 inhibitors; Bimzelx; Cosentyx; drug market potential

Placebo Response Trips Up Harmony Biosciences’ Fragile X Drug in Late-Stage Phase 3 Trial

4 months ago talkbio0Tagged Clinical Research, Clinical trial failure, Fragile X Syndrome, Harmony Biosciences, Placebos, RECONNECT, Response process, transdermal cannabidiol gel

Harmony Biosciences; ZYN002; Fragile X syndrome; Phase 3 trial; placebo response; clinical trial failure; RECONNECT study; transdermal cannabidiol gel

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

5 months 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

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

6 months 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

Spine BioPharma’s Phase 3 Back Pain Drug Fails to Meet Primary Endpoint, Attributes Miss to High Sham Response

6 months ago talkbio0Tagged Chronic low back pain, Clinical Trials, Intervertebral Disc Degeneration, primary endpoint, Response process, salicylhydroxamic acid, SB-01, Spine BioPharma

Spine BioPharma; Phase 3 trial; chronic low back pain; degenerative disc disease; SB-01; primary endpoint; sham response; clinical trial results