Strong Phase III Data Have Linaclotide On Track For Filing In 2011
Ironwood Pharmaceuticals and its partner, Forest Laboratories, announced Sept. 13 strong top-line results from a Phase III trial of linaclotide in irritable bowel syndrome with constipation (IBS-C) – an important signal of support for investors' confidence in the high-profile biotech.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).
The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.