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Latest From Approvals
US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.
Keeping track of US FDA approvals last week included watching the creative and the familiar.
The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.
Original new drugs and biologics recently approved by US FDA.
Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.
The latest drug development news and highlights from our US FDA Performance Tracker.
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