Qualitative Concept – Page 3

Exclusive: Compounding giant Empower Pharmacy cuts hundreds of staff, stops New Jersey operations

1 month ago talkbio0Tagged compounding pharmacy, East Windsor facility, Empower Pharmacy, Facility (object), Glucagon-Like Peptide 1, Inspection (procedure), layoffs, manufacturing shutdown, New Jersey operations, Outsourcing, Qualitative form, United States Food and Drug Administration, Workforce reduction

Empower Pharmacy; compounding pharmacy; layoffs; job cuts; New Jersey operations; East Windsor facility; manufacturing shutdown; outsourcing facility; FDA inspection; Form 483; compounded GLP-1 drugs; workforce reduction

Nektar Digs Into Mid-Stage Data To Establish Alopecia Efficacy of Rezpeg

1 month ago talkbio0Tagged Alopecia, Autoimmune Diseases, Effectiveness, eli lilly, IL-2 pathway, mid-stage trial, Nektar Therapeutics, Phase 3 planning, REZOLVE-AA, Rezpeg, Rezpegaldesleukin, SALT score * *, Signal

Nektar Therapeutics; rezpegaldesleukin; Rezpeg; REZOLVE-AA; Phase 2b; alopecia areata; hair loss; SALT score; mid-stage trial; efficacy signal; Eli Lilly; IL-2 pathway; autoimmune disease; Phase 3 planning

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

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

1 month ago talkbio0Tagged AR navigation, augmented, Clearance, Cranial Navigation platform, cranial neurosurgery, External Ventricular Drain, ICU bedside procedures, intraoperative guidance, Medivis, neurosurgery innovation, Spine Navigation, surgical intelligence, United States Food and Drug Administration

Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation

China’s fast, low-cost gene and cell therapy testing boom draws Western interest

1 month ago talkbio0Tagged Advanced Therapy Medicinal Products, ATMP regulation China, CDE, Cell Therapy, China, clinical trial review, Clinical Trials, gene therapy, N-methyl-N-2-(methylsulfinyl)ethylpropionic acid amide, reforms, Shortened, therapies testing, Western biotech

China clinical trials; gene therapy; cell therapy; advanced therapy medicinal products; ATMP regulation China 2025; shortened clinical trial review; cheap clinical trials; Western biotech in China; NMPA CDE reforms; novel therapies testing

FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer

1 month ago talkbio0Tagged Approved, Carcinoma breast stage IV, Enhertu, first-line, HER2-positive, Perjeta, United States Food and Drug Administration

Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line

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

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

1 month 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

1 month 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

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

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