Cepheid Wins FDA Clearance for Xpert CT/NG, TranS1 Settles with DOJ: Healthcare Business Recap
On Friday, Mylan (NASDAQ:MYL) reported that its partner, Famy Care, won final approval from the FDA for its Abbreviated New Drug application for Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg. This product is the generic version of Teva Pharmaceutical Products’ (NYSE:TEVA) Nordette 28 tablets which are indicated for the prevention of pregnancy in women who choose to use this product as a method of contraception. The drug will be distributed in the United States by Mylan and it is shipping immediately.
Cepheid (NASDAQ:CPHD) receives FDA clearance to market Xpert CT/NG which runs on the company’s GeneXpert Systems. Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae, marking the first time that same-day patient consultation and treatment is possible for the two most common sexually transmitted bacterial infections in the country.
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The medical device company TranS1 (NASDAQ:TSON) said Friday that it had reached a tentative accord in principle with the United States Department of Justice concerning the subpoena issued in October of 2011. On December 24th, the parties tentatively agreed to resolve its federal inquiry for $6 million, subject to completion and approval of written settlement agreements with the Department and the HHS-OIG which are expected to be completed in the first months of 2013. TranS1 admits no wrongdoing as part of the resolution.
Synergy Pharmaceuticals (NASDAQ:SGYP) has successfully completed of a Phase I single-ascending-dose clinical trial of SP-333, a guanylate cyclase C agonist created to treat ulcerative colitis and other GI diseases. The medication has shown potent anti-inflammatory activity in animal studies of colitis, displaying a novel mechanism-of-action that the firm believes can provide a new way in which to treat UC patients with mild to moderate disease.
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