Gilead To File Truvada For HIV Prevention In EU In Early 2016
This article was originally published in Scrip
Executive Summary
Gilead Sciences has confirmed that it is preparing a regulatory filing in Europe for its HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate ) for pre-exposure prophylaxis (PrEP), and that a submission is expected sometime in the first quarter of 2016.
You may also be interested in...
'Don't Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas Cueni
Thomas Cueni is stepping down after seven years at the helm of the International Federation of Pharmaceutical Manufacturers and Associations. In an interview with the Pink Sheet ahead of his retirement, he reflects on the proposed pandemic treaty, what still needs to be done to ensure equitable access to medicines, the importance of tackling AMR, moves towards regulatory reliance – and what his post-IFPMA life might look like.
EU Warns Of Life-Threatening Interactions Between Paxlovid & Some Immunosuppressants
The EU’s pharmacovigilance committee says that a review of the available evidence showed that in several cases, blood levels of immunosuppressants increased rapidly to toxic levels in patients who were taking the Pfizer drug.
Latest Changes To EU Regulatory Data Protection Mean New ‘Uncertainties & Risks’
Law firm Sidley Austin says the net overall effect of the pharmaceutical package on innovation and investment is “uncertain at best.”