Sanofi will this week learn whether fexinidazole, the drug the company is developing for sleeping sickness, will be evaluated quickly once it files for approval. The European Medicines Agency’s CHMP is considering this week whether to grant the company’s request for accelerated assessment.
Sanofi should learn soon whether or not the European Medicines Agency ‘s CHMP will accept the firm’s application for accelerated assessment for its sleeping sickness drug fexinidazole. The committee is this week deciding the matter, a positive outcome for the firm would bring the goal of eradicating the disease closer.
Fexinidazole would be evaluated under the Article 58 procedure for drugs intended for developing countries.
<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.
