Moderna seeks damages for sales of Comirnaty in US and other wealthy countries from 8 March onward, a timeframe driven by Moderna's accessibility pledge. Suit claims Pfizer and BioNTech copied two key features of its mRNA technology for their rival COVID vaccine.
Moderna, Inc. staked out a broad claim to mRNA technology in filing patent infringement complaints against Pfizer Inc. and BioNTech SE. While Moderna is focused on obtaining compensation for use of the technology in the Pfizer/BioNTech COVID-19 vaccine Comirnaty, the dispute could have implications on application of the technology to other diseases.
However, analysts predict that the most likely outcome will be that Moderna and Pfizer/BioNTech both pay modest royalties for their...
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.’
US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
