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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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LQTT secures $19M; Nanox acquires Zebra Medical Vision; Takeda leads IBD drugVisus raises $20M

Delveinsight

Through its development and use of different algorithms, Zebra Medical has been able to recognize visual symptoms for diseases such as breast cancer , osteoporosis , and fatty liver , as well as conditions such as aneurysms and brain bleeds. The original agreement had Finch responsible for early-stage development through phase 2 studies.

Trials 97
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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. Malaria Vaccine Phase II Trial.

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Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?

Delveinsight

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. Why the Need?

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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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FDA Cracks Down on ClinicalTrials.gov Reporting Failures

FDA Law Blog

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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Broadening Your Pharma Network on LinkedIn

Pharma Marketing Network

You can find numerous pharma-specific groups dedicated to topics like drug development , market access , and pharmaceutical marketing. Sharing Branded Drug Updates and Innovations LinkedIn is a fantastic platform to share updates on branded drug innovations.