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Vamorolone

New Drug Approvals

Example 2: Synthesis of the present invention Scheme C: Route of Synthesis of Vamorolone from 8-DM Vamorolone was synthesized in three synthetic steps from commercially available 8-DM. “Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy” Journal of Clinical Pharmacology.

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Landiolol

New Drug Approvals

Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. Yield:144481-98-1 95.9% August 2000). 2000.108733.

FDA 62
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Trends & Insights: Spotlight Winter Edition

DrugBank

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. DrugBank Powered Research: Pharmacological knowledge about drug targets was analyzed based on a query of DrugBank. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

Government shutdown: At present, the U.S. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. Expect nearly every company to be closely reading this document when it’s eventually published.

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