Active Deal-Making Year Anticipated In HCV As New, Better Drug Combos Emerge
• By The Pink Sheet
Following the European Association for the Study of the Liver's annual meeting this past week in Vienna, Austria, it became clear that most companies active in the hepatitis C space hope to be part of the current best hope for HCV therapy: a once-daily, oral cocktail of antiviral drugs that will replace the current standard of care
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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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As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
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In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.