EU Biosimilar Filings, Opinions And Approvals
Executive Summary
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
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'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.”