Organism Function – Page 4

FDA Halts Kezar’s Lupus Nephritis Trial Due to Safety Concerns Following Four Patient Deaths

8 months ago talkbio0Tagged Cessation of life, concerns, Kezar Life Sciences, Lupus Nephritis, Safety, Study on Hold, United States Food and Drug Administration, Zetomipzomib

FDA, Kezar Life Sciences, lupus nephritis, zetomipzomib, clinical hold, patient deaths, safety concerns

Kezar Life Sciences Suspends Enrollment and Dosing in Phase 2b PALIZADE Trial Due to Safety Concerns

8 months ago talkbio0Tagged Cessation of life, clinical trial halt, concerns, Kezar Life Sciences, Lupus Nephritis, PALIZADE, Safety, Zetomipzomib

Kezar Life Sciences, PALIZADE trial, zetomipzomib, lupus nephritis, safety concerns, patient deaths, clinical trial halt

Elinzanetant Demonstrates Sustained Efficacy Over One Year in Managing Menopausal Vasomotor Symptoms

9 months ago talkbio0Tagged Bayer, Elinzanetant, Menopause, Non-Hormonal, Sleep, Symptoms aspect, Vasomotor

Elinzanetant, Menopause, Vasomotor Symptoms, Sleep Disturbances, Non-Hormonal Treatment, Bayer

George Medicines Unveils Promising Low-Dose Triple Combination Pill for Hypertension Management

9 months ago talkbio0Tagged control of blood pressure, George Medicines, GMRx2, Hypertensive disease, Low-Dose Treatment, Triplicate

Hypertension, Triple Combination Pill, Low-Dose, Blood Pressure Control, GMRx2, George Medicines

Novo Nordisk’s Wegovy Approved in China: Implications and Future Challenges

10 months ago talkbio0Tagged Approved, China, competition, Expiration, function, Legal patent, Nordisk, Obesity, pharmaceutical market, semaglutide, Wegovy

Novo Nordisk, Wegovy, semaglutide, obesity treatment, China approval, generic competition, patent expiration, pharmaceutical market

BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease

11 months ago talkbio0Tagged Alfa, BioMarin, Brineura, cerliponase, Child, Deterioration, expansion, Injection of therapeutic agent, Intraventricular, Labels (device), motor ability, Neurodegenerative, Symptoms aspect, TPP1 gene, United States Food and Drug Administration

BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms

Samsung Bioepis Sees 107% Sales Growth in Q2, Driven by Biosimilars

11 months ago talkbio0Tagged Bioepis, Biosimilars, Growth, Market, operating profit, Sales - occupational activity, Samsung

Samsung Bioepis, biosimilars, sales growth, Q2, operating profit, market share

Bluebird Bio’s Fertility Support Program for Gene Therapies Rejected by HHS Inspector General

11 months ago talkbio0Tagged Anti-Kickback Rules, CHARGE Syndrome, Family Turdidae (organism), Fertility, gene therapy, Generalized, Inspector, Skysona, Support, device

Bluebird Bio, Gene Therapy, Fertility Support, HHS Inspector General, Zynteglo, Skysona, Anti-Kickback Rules

Vertex Pharmaceuticals Sues US Government Over Fertility Assistance Program for Gene Therapy Patients

11 months ago talkbio0Tagged Biologic Preservation, Fertility, gene therapy, Government, Health Insurance

Vertex Pharmaceuticals, gene therapy, fertility assistance program, lawsuit, US government, health insurance, fertility preservation

Taysha Gene Therapies Announces Positive Results for TSHA-102 in Rett Syndrome Trials

12 months ago talkbio0Tagged autonomic function, Communication, gene therapy, Motor Skills, Rett Syndrome, Seizures, Taysha Gene Therapies, TSHA-102

Taysha Gene Therapies, TSHA-102, Rett Syndrome, Gene Therapy, Motor Skills, Communication, Autonomic Function, Seizures