1. Pink Sheet

Keeping Track: KemPharm Apadaz Delay; Cholera Vaccine Approved

 
• By Mary Jo Laffler and Bridget Silverman

The latest drug development news and highlights from our FDA Performance Tracker. Vaxchora cholera vaccine is CBER's fourth novel biologic cleared this year; Adamis emergency Epi turned down again.

FDA had a slow week for approvals, but capped it with the Center for Biologics Evaluation and Research's fourth novel biologic approval of the year, for the first FDA-approved vaccine to prevent cholera.

The Center for Drug Evaluation and Research cleared a new drug application (NDA) for a new anti-hypertensive, but issued a second complete response letter (CRL)

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Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

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EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
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