ORG – Talk Bio

FDA approves new gonorrhea antibiotics from GSK and Innoviva

2 days 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

SABCS 2025 Highlights: Celcuity’s Phase 3 VIKTORIA-1 Updates and Relay PI3K Inhibitor News

2 days ago talkbio0Tagged Celcuity, gedatolisib, Malignant neoplasm of breast, Phase 3, PI3 K inhibitors, PIK3CA gene, Relay Device, SABCS25, VIKTORIA-1, wild-type

SABCS25; Celcuity; VIKTORIA-1; gedatolisib; PIK3CA wild-type; Phase 3; breast cancer; Relay; PI3K inhibitors

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

2 days 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 days 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

The Endpoints 100: Biotech CEOs are feeling more upbeat about the road ahead

2 days ago talkbio0Tagged Attitude, biopharma executives, CEOs, dealmaking, E100 survey, Endpoints, Industry, IPO, Market, Recovery - action, reorganization, Sentiment, Trump administration, United States Food and Drug Administration, Window (physical object)

Endpoints 100; E100 survey; biotech CEOs; biopharma executives; industry sentiment; market recovery; dealmaking; IPO window; Trump administration; FDA reorganization; tariffs; 2025 outlook

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

2 days 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

Pfizer, Geron Downsize to Streamline Costs

2 days ago talkbio0Tagged commercial strategy, cost-cutting, Geron, Pfizer, Rytelo, Staff, Switzerland

Pfizer layoffs Switzerland; Geron layoffs one-third staff; cost-cutting; restructuring plan; Rytelo commercial strategy; Pfizer cost realignment; biopharma layoffs 2025

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

2 days 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 days 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

3 days 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