As personalized medicine shifts from theory to practice, concerns are mounting about whether the evidence behind many biomarkers is sufficient to make pharmacogenomic testing worthwhile – suggesting sponsors should pay careful attention to providing evidence to support use of companion diagnostics.
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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.’
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.
Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.
