Safety and immunogenicity data may not be sufficient to get FDA authorization of COVID-19 vaccines against a variant, FDA’s Doran Fink says. For now, agency expects to see clinical data. Eventually, strain changes might be based on manufacturing information.
The US Food and Drug Administration may not authorize a modified COVID-19 vaccine to protect against SARS-CoV-2 variants based solely on safety and immunogenicity data, and at least for now expects to see clinical data, FDA’s Doran Fink said.
Speaking at the National Vaccine Advisory Committee’s 17 June meeting, Fink, deputy director for clinical review in the Division of...
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
