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News Breaks
October 28, 2009
14:06 EDTFRX
theflyonthewall.com: Forest Labs, Gedeon announces positive Cariprazine Phase IIb study results
Forest Laboratories and Gedeon Richter announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia. For the primary endpoint, the Positive and Negative Syndrome Scale, the data showed that patients with schizophrenia treated with cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied. Based on this latest schizophrenia data, subject to a complete review of the full results, and the previously announced Phase II results in patients suffering from acute mania associated with bipolar I disorder, the companies intend to initiate Phase 3 trials for both indications in early 2010. Cariprazine is currently also undergoing Phase II clinical trials in patients with Bipolar Depressive Disorder and as adjunctive therapy in Major Depressive Disorder. :theflyonthewall.com



News For FRX From The Last 14 Days
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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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