Takhzyro Among Hopefuls For EU Approval Recommendation
A handful of companies are expected to find out this week whether their products will be recommended for EU approval. The EMA's drug evaluation committee, the CHMP, is due to give its opinion on marketing authorization on two orphan drugs for use in HAE and myotonia respectively, another biosimilar trastuzumab, and a flu vaccine.
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Kiadis has conducted further analyses of data on its investigational blood cancer therapy ATIR101 and is now hoping to secure EU approval in time for the therapy to be used in the first patients by the end of 2019.
Dengvaxia, the dengue vaccine from Sanofi that was suspended in the Philippines last year, is among six new products to get a recommendation for marketing authorization from the European Medicines Agency this week.
As the European Medicines Agency gets on with its fast-track review of bluebird bio's LentiGlobin gene therapy, the Pink Sheet takes a look at the year so far in the area of accelerated assessment. Daiichi Sankyo is keeping us guessing on whether its investigational new product, quizartinib, will also be fast-tracked once filed.