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.’
Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.
Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
