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News Breaks
February 10, 2014
08:07 EDTFRX, IRWDIronwood receives NOA for patent expected to extend LINZESS patent protection
Ironwood Pharmaceuticals (IRWD) announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent application covering methods of using LINZESS to treat patients with irritable bowel syndrome with constipation or chronic idiopathic constipation. The patent application, co-owned by Ironwood and Forest Laboratories (FRX), is expected to issue in mid-2014 and extend LINZESS patent protection into 2031. LINZESS is approved and marketed in the United States for the treatment of adult patients suffering from IBS-C or CIC. It is the first and only guanylate cyclase-C agonist approved by the FDA.
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April 9, 2014
05:50 EDTFRXForest Labs reports FDA provided feedback on combination aclidinium, formoterol
Forest Laboratories announced that they have recently received feedback from the FDA regarding the fixed dose combination of aclidinium and formoterol. Although no new issues have arisen, further discussion is needed with the Agency in order to address questions related to CMC, or Chemistry, Manufacturing and Control, and a Type C meeting with the FDA is going to be requested, likely to be held during Q3 this year. Forest and Almirall believe that the fixed dose combination of aclidinium and formoterol can be an important therapy for U.S. COPD patients.

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