FierceBiotech

PRESS RELEASE: FDA approves Mircera: first renal anemia treatment in the US with monthly maintenance dosing

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anaemia associated with chronic kidney ...
Healio

Study finds clinicians do not consistently use algorithms when dosing Mircera

Please provide your email address to receive an email when new articles are posted on . Even with algorithms available, dosing for Mircera appears to vary widely among nephrologists. Dialysis clinics ...
Europa Press

Pivotal MIRCERA Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Four Weeks

A pivotal study published today in the Lancet has shown that dialysis patients can be effectively switched from frequently dosed anaemia drugs to an innovative new anaemia treatment, MIRCERA, that can ...
Europa Press

Innovative New Anaemia Drug MIRCERA Demonstrates Ability to Maintain Tight Haemoglobin Levels at Once Monthly Dosing in

-- First Publication of Phase III Data in the Clinical Journal of the American Society of Nephrology Results from a multi-centre renal anaemia study show that switching patients directly from frequent ...
PharmaTimes

Clinical data back efficacy of Roche’s Mircera

New data for Roche’s anaemia drug Mircera confirm that the drug can raise haemoglobin levels in the blood with twice-monthly dosing, suggesting it will mount a strong challenge to current treatments ...
Reuters

Analyses show Roche's Mircera is safe, effective

ZURICH, April 13 (Reuters) - Swiss drugmaker Roche's experimental medicine Mircera is safe and effective for the treatment of renal anaemia associated with chronic kidney disease, pooled data from ...
FierceBiotech

PRESS RELEASE: Mircera approved in European Union for treatment of anaemia related to chronic kidney disease

Roche announced today that the European Commission has approved its innovative drug Mircera to treat anaemia associated with chronic kidney disease (CKD). The approval of Mircera results in a single ...
MarketWatch

Roche gets positive opinion for Mircera

LONDON (MarketWatch) -- Swiss drugmaker Roche said Friday that it has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing ...
FiercePharma

Amid dispute with FDA, Akebia proposes new dosing for oral anemia drug in kidney disease

Akebia Therapeutics isn’t giving up on its oral anemia drug vadadustat despite an FDA rejection and a partnership gone awry. Now, just as the company challenges the FDA decision, Akebia has offered ...
ots

Innovative New Anaemia Drug MIRCERA Demonstrates Ability to Maintain Tight Haemoglobin Levels at Once Monthly Dosing in Dialysis Patients With Chronic Kidney Disease

three times a week for the maintenance treatment of anaemia. The study results showed: - Minute changes in patients' haemoglobin (Hb) levels from baseline to evaluation (-0.131g/dL for MIRCERA once ...
Medindia

FDA Approves MIRCERA(R): First Renal Anemia Treatment with Monthly Maintenance Dosing

NUTLEY, N.J., Nov. 14 Roche announced today that the U.S. Food and Drug Administration (FDA) has approved MIRCERA (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with ...