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Aventis DTaP Concurrent Use Data Should Precede Approval, Committee Says
Approval for Aventis' five-component DTaP vaccine should await submission of safety and immunogenicity data with respect to its use in combination with other childhood vaccines, FDA's Vaccines & Related Biological Products Advisory Committee said Nov. 3.
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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.’
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Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.
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Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.
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One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.