Highly negative FDA advisory committee review and subsequent discussions with the agency made clear the only path forward was a new study, company executives said. Troubled application shows the limits of FDA’s willingness to exercise regulatory flexibility.
BrainStorm Cell Therapeutics Inc. expects to focus a new Phase III trial for NurOwn (debamestrocel) on amyotrophic lateral sclerosis patients with mild or less advanced disease, the company said in announcing withdrawal of the US biologics license application for the mesenchymal stromal cell therapy.
On 18 October, BrainStorm execs said they are withdrawing the NurOwn application, which was filed over protest by the Food...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
