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 simulator could also be used by pharmaceutical companies to rapidly test multiple drug therapies and patient scenarios, increasing the speed and cost of drug development. The post Mathematical model can speed up Alzheimer’s drug development appeared first on Drug Discovery World (DDW).
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.
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.
International Women’s Day: Female life science leaders
Drug Discovery World
MARCH 7, 2023
For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. Here at FAB our proprietary approach aims to overcome this fundamental challenge to human health as we work to discover and develop new drugs for age-associated diseases.”
FDA Cracks Down on ClinicalTrials.gov Reporting Failures
FDA Law Blog
MAY 3, 2021
for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).
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