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FDA Approvals for a Liquid Epilepsy Drug and Vitiligo Medication – Xtalks Life Science Podcast Ep. 71

XTalks

In this episode, Ayesha discussed the FDA approval of Azurity Pharmaceutical’s Zonisade (zonisamide oral suspension) as an adjunct therapy for the treatment of seizures in adults and pediatric patients 16 years of age and older with epilepsy. The drug is the first FDA approved oral suspension form of zonisamide.

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Machine learning: A useful tool in the development of next generation antibody therapeutics

Drug Discovery World

Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.

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Mathematical model can speed up Alzheimer’s drug development

Drug Discovery World

Researchers have created a mathematical model that can accurately depict Alzheimer’s disease progression in individual patients, paving the way for personalised treatment and faster development of therapies. These findings closely matched the results of the corresponding real-life clinical trials.

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Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations

XTalks

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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Vicore initiates clinical proof-of-concept study of endothelial dysfunction 

Drug Discovery World

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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An Evolving Regulatory Environment for Rare and Orphan Diseases

Advarra

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.