Remove Clinical Pharmacology Remove Therapies Remove Trials
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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. Patients and caregivers also assess the benefits offered by different therapies, weighing the progression-free survival with their off-target effects. 3D rendering of Antibody Drug Conjugate Molecules.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog: Drug Discovery

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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AdComms – Is FDA Getting Less Advice?

Eye on FDA

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

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First clinical trial for MDMA and LSD combination set to go ahead

The Pharma Data

The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.

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Biomarker identification in the realm of rare diseases

Drug Target Review

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials.

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Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Alta Sciences

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s We are proud to support Ischemix in advancing this vital new therapy.”

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Shaping drug development success: how does artwork play a role?

Drug Target Review

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation.