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What recent paediatric guidelines mean for drug developers 

Drug Discovery World

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.

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Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023. He gave the example of GLP-1 receptor agonist Ozempic, a diabetes treatment, which was successfully repurposed for weight loss as Wegovy.

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Eplontersen

New Drug Approvals

Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023.

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Zelatriazin

New Drug Approvals

It was developed for schizophrenia and anhedonia in depression but trials were unsuccessful and its development was discontinued in 2023. [1] “Discovery of TAK-041: a Potent and Selective GPR139 Agonist Explored for the Treatment of Negative Symptoms Associated with Schizophrenia” Journal of Medicinal Chemistry.

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Top 10 Life Science Resources

Alta Sciences

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read or listen now. Watch it now.

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Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. In January 2023, the White House announced that the federal Covid-19 national emergency and PHE would officially end on May 11, 2023.

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Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.” Current guidelines recognize risks of malformation and fetal demise with anticancer treatments, especially conventional chemotherapy.

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