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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LQTT secures $19M; Nanox acquires Zebra Medical Vision; Takeda leads IBD drugVisus raises $20M
Delveinsight
AUGUST 12, 2021
AbbVie reported the success of two phase 3 trials of its drug trial in October and filed for FDA approval in February. Eyenovia said it had the primary endpoint in phase 3 clinical trial in May, although it still needs to run a second study.
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.
Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy
XTalks
APRIL 26, 2021
Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa.
Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?
Delveinsight
AUGUST 13, 2021
The drug development process is a lengthy and time-intensive process that ends up causing fortunes to industries and organizations sponsoring the process. According to a study by the Tufts Centre for the Study of Drug Development, approximately USD 2.6B Regulatory agencies have always prioritized the well-being of the patients.
FDA Cracks Down on ClinicalTrials.gov Reporting Failures
FDA Law Blog
MAY 3, 2021
The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.
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