Sun.Apr 03, 2022

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Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients

JAMA Internal Medicine

This randomized clinical trial investigates whether daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is safe and noninferior compared with darbepoetin alfa in treating anemia of chronic kidney disease in incident dialysis patients.

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Cardiovascular Outcomes at Weeks 48 and 84 in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Receiving Mavacamten

The Pharma Data

Treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels. At 48 and 84 Weeks, Mavacamten safety was consistent with that seen in the EXPLORER-HCM study. Interim results were presented as a late-breaking clinical trial at the American College of Cardiology’s 71 st Annual Scientific Session.

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What Can At-home Genetic Tests Tell Me About My Health?

JAMA Internal Medicine

This JAMA Internal Medicine Patient Page describes the use and accuracy of, as well as harms and concerns associated with, at-home genetic tests.

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Which pharmaceutical companies have the most drug patents in Brazil?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Brazil. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Brazil? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Not An April Fool’s Joke: California BOP Establishes Loss Reporting Thresholds

FDA Law Blog

By Larry K. Houck — Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form. Instead, the amended loss regulations establish thresholds which will reduce the number of reports received by the California BOP, and in our opinion, creates a more meaningful and substantive reporting system.