With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.
The public hearing on the US Center for Drug Evaluation and Research’s proposal to withdraw accelerated approval of Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) appears on track for 2022.
Although a hearing date is not yet announced, presiding officer Celia Witten is asking CDER and Covis to provide specific...
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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