Springworks shares fall despite drug trial's success
Bio Pharma Dive
MAY 24, 2022
The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.
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FDA Approvals for a Liquid Epilepsy Drug and Vitiligo Medication – Xtalks Life Science Podcast Ep. 71
XTalks
AUGUST 3, 2022
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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Mathematical model can speed up Alzheimer’s drug development
Drug Discovery World
NOVEMBER 29, 2023
“The most important benefit is that we now have an accurate model that we can use to perform virtual experiments with different types of interventions, quickly and digitally.”
Vicore initiates clinical proof-of-concept study of endothelial dysfunction
Drug Discovery World
MAY 3, 2023
Official comments “Measuring endothelial dysfunction with the EndoPAT technology in drug trials is a cost-effective and robust method for early documentation of proof-of-concept in pulmonary, renal and vascular diseases” says Elin Rosendahl, VP Clinical Operations, Vicore Pharma.
An Evolving Regulatory Environment for Rare and Orphan Diseases
Advarra
AUGUST 16, 2022
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.
International Women’s Day: Female life science leaders
Drug Discovery World
MARCH 7, 2023
She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials. Other roles include Head of Biology at TopoTarget A/S, where she was responsible for the pre-clinical development of belinostat which went on to gain FDA approval to treat peripheral T-cell lymphoma.
Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations
XTalks
AUGUST 4, 2022
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.
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