At Oct. 3 meeting, FDA's Antiviral Drugs Advisory Committee unanimously recommends use of Gilead's antiviral Viread (tenofovir disoproxil fumarate) in adult patients with HIV infection who have received prior antiretroviral therapy. Due to a lack of data in treatment-naive patients and other concerns, a majority of committee members favored restricting use to treatment-experienced patients. Gilead is conducting a 601-patient Phase III trial in treatment-naive subjects, and analysis of results should be completed in the first half of 2002
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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.
