Development Drug Trials FDA Approval Regulation 
Drug Discovery World
MAY 21, 2024
Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.
XTalks
APRIL 26, 2021
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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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.
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.
Delveinsight
AUGUST 12, 2021
LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome. The original agreement had Finch responsible for early-stage development through phase 2 studies.
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