Internal emails show the 2011 hearing on Genentech’s VEGF-inhibitor was taxing for FDA employees, who had to deal with a number of novel issues; the workload is likely to be similarly complex for staff involved in upcoming hearing on Covis’ preterm birth prevention drug Makena.
With the US Food and Drug Administration still strained by the COVID-19 pandemic, the last thing the agency needs is a lengthy administrative proceeding that drains time and resources.
However, that’s the direction in which the agency is headed with the forthcoming public hearing on the Center for Drug...
The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.
The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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