New BTDs include Loxo’s RET inhibitor for RET fusion-positive lung cancer and RET mutant medullary thyroid cancer, Y-mAbs’ naxitamab for high-risk neuroblastoma, AstraZeneca/Amgen’s tezepelumab for severe asthma, and Pfizer’s JAK3 inhibitor for alopecia areata.
While oncologics remain the mainstay of US FDA’s flagship regulatory incentive program, the breakthrough therapy designation (BTD), recent awards illustrate how the program is encouraging development for unmet needs within big markets like respiratory disease and dermatology.
Respiratory disease, one of AstraZeneca PLC’s primary areas of focus for R&D, has now earned the company a breakthrough...
<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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