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Writing about @US_FDA pharma regulation for @PharmaPinkSheet. Also a long-suffering fan of the @Mets, @nyjets and @nyknicks. Views are my own.

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@mcipriano93 — 469 followers, 1,728 tweets

Antimicrobial Drugs Advisory Committee votes 14-2 that $SGIOY has provided substantial evidence of the efficacy and sufficient evidence of the safety of cefiderocol for the treatment of complicated urinary tract infections in patients w/ limited or no alternative treatments.
Antimicrobial Drugs Advisory Committee meeting today to discuss $SGIOY's cefiderocol for treatment of complicated urinary tract infections. Issue is possibility mortality imbalance in supportive clinical trial.  https://pink.pharmaintelligence.informa.com/PS141009/Possible-Mortality-Imbalance-For-Shionogis-Cefiderocol-On-US-FDA-Panel-Agenda 
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