Antibiotic sponsors wonder whether RWE would be sufficient to convert a product to full approval. Ahead of US FDA's public meeting on the LPAD guidance, industry has a number of lingering questions.
Can real-world evidence be sufficient to support a supplemental application for lifting the restrictions of the 21st Century Cures Act's limited population antibacterial drug (LPAD) pathway? Or would a clinical trial be required?
These are among the many questions industry has raised about LPAD as the US Food and Drug Administration readies for...
<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.
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