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Zydus receives USFDA approval to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with ALS

Express Pharma

Zydus has previously completed a Phase 2(a) randomised, double-blind, placebo-controlled clinical trial in 24 ALS patients across 7 clinical trial sites in India. It is planned to present this Phase 2(a) trial data in an upcoming medical conference and publish in a medical journal. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318.

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ACMT Toxicology Visual Pearl: Who Doesn’t Like a Nice Rosé?

ALiEM - Pharm Pearls

What clinical presentation and medication is associated with this urinary discoloration? Hypersensitivity reactions to rifampin: Pathogenetic mechanisms, clinical manifestations, management strategies, and review of the anaphylactic-like reactions. Medicine (Baltimore) 1999;78(6):361-9. PMID 10575418 Kaakkola S.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

Cannabis complications There are notable complexities to researching medical cannabis using a linear approach to clinical translation. 5 These are each present at varying concentrations depending on underlying plant genetics and growing conditions. Expert Review of Clinical Pharmacology. British journal of pharmacology.

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New Initiative of the US FDA: The Role of Pharmacodynamic Biomarkers for the Development of Biosimilar

PharmaShots

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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Episode 573: Ceiling dose of ketorolac for renal colic in the ED

Pharmacy Joe

In 1989, a study in the Journal of Clinical Pharmacology compared 10, 30, and 90 mg of IM ketorolac with placebo in 126 patients with cancer pain. While all doses were more effective than placebo, there was no difference in effectiveness between 10, 30, or 90 mg of IM ketorolac. 165 patients were split evenly between the 3 groups.

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Uncovering the potential of ADCs to target tumours

European Pharmaceutical Review

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. Exploration of the antibody–drug conjugate clinical landscape. Rise of Antibody-Drug Conjugates: The Present and Future. Signal Transduct Target Ther. 2022; 7(93) Maecker et al.

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Developing new treatment regimens for HIV

European Pharmaceutical Review

For more than 15 years, integrase strand transfer inhibitors (INSTIs) have served as the foundation of ART regimens in HIV treatment guidelines around the world and our present portfolio is built on them. With therapeutic expertise in HIV, hepatology and rare diseases, Sherene has additional expertise in clinical pharmacology and drug safety.