Re: CANTOS good, but FDA not on board with sub-group analysis

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BearDownAZ

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Re: CANTOS good, but FDA not on board with sub-group analysis

in response to

CANTOS good, but FDA not on board with sub-group analysis

BearDownAZ

posted on Dec 14, 2018 03:17PM

First it was the FDA, now the EMA. No love from either agency for giving Novartis approval to market canakinumab (anti-inflammatory anti-IL1B antibody) for reducing MACE. Great opportunity for some other novel therapy with anti-inflammatory properties to swoop in.

Withdrawal of the marketing authorisation application for canakinumab Novartis (canakinumab)

FDA slaps down Novartis’ blockbuster pitch for canakinumab — so what went wrong?

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