article thumbnail

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.

article thumbnail

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. The post Mathematical model can speed up Alzheimer’s drug development appeared first on Drug Discovery World (DDW).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

Drug Discovery World

Patients with diabetes mellitus have an increased risk of cardiovascular events and endothelial dysfunction is an important factor for this development” said Jan Nilsson, Professor in Experimental Cardiology, Lund University, and principal investigator in the trial.

article thumbnail

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.

article thumbnail

International Women’s Day: Female life science leaders

Drug Discovery World

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials.

article thumbnail

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. Malaria Vaccine Phase II Trial.

article thumbnail

Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations

XTalks

This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. An analysis of trials that supported FDA approvals of new cardiometabolic drugs from 2008 to 2017.