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News Breaks
November 3, 2009
05:00 EDTFRX
theflyonthewall.com: Forest Labs and Ironwood announce positive Linaclotide results
Ironwood Pharmaceuticals and Forest Laboratories announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation. Analyses of the data indicate that in both multicenter, randomized, double-blind, placebo-controlled trials, statistical significance was achieved for the primary endpoint of 12-week complete spontaneous bowel movement overall responder at the two doses studied in each trial. In both trials, statistical significance was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs. :theflyonthewall.com



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February 8, 2012
18:41 EDTFRX
theflyonthewall.com: Ironwood Pharmaceuticals: No FDA advisory meeting for NDA of Linaclotide
Ironwood Pharmaceuticals (IRWD) announced that it was informed this evening that the U.S. FDA will not schedule an advisory committee meeting in connection with the its review of the New Drug Application for linaclotide proposed for the treatment of irritable bowel syndrome with constipation and chronic constipation. On August 9, 2011, Ironwood, along with its partner Forest Laboratories (FRX), announced that they submitted the NDA for linaclotide to the FDA. Under the FDA's Prescription Drug User Fee Act, the companies anticipate action by the FDA in June, approximately 10 months from the submission date. :theflyonthewall.com
14:40 EDTFRX
theflyonthewall.com: FDA discloses ANDA submitted for generic Bystolic

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06:03 EDTFRX
theflyonthewall.com: Forest Labs and Gedeon Richter announce positive cariprazine Phase III results

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January 31, 2012
11:21 EDTFRX
theflyonthewall.com: Piper Jaffray's biotech and specialty pharma analysts hold a conference call

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