Centocor Ortho Biotech's Stelara (ustekinumab) brings a novel mechanism and superior efficacy to the plaque psoriasis marketplace, but in terms of risk management, the anti-inflammatory biologic differs little from the tumor necrosis factor inhibitor class
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.
Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.
