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News Breaks October 16, 2012 08:30 EDT ISIS, SNY FDA panel says risk plan for Isis, Sanofi drug would support appropriate use In briefing documents ahead of an advisory committee meeting on October 17, an FDA panel stated, "Because of the potential risk of hepatotoxicity, mipomersen could not be approved without the necessary safeguards to restrict prescribing to certified prescribers who understand that mipomersen must be used only for treating patients in whom the benefit is thought to exceed this risk." The documents outline a proposed Risk Evaluation and Mitigation Strategy, or REMS, for the drug that would restrict prescribing to only certified prescribers and dispensing of mipomersen to only certified pharmacies. The panel stated, "The REMS proposed above would support appropriate use of mipomersen, allowing it to be approved for use in the targeted patient population, a patient population with life threatening illness and limited therapeutic options, while protecting the larger hypercholesterolemic patient population." The drug is being developed by Genzyme, a unit of Sanofi (SNY), in partnership with Isis Pharmaceuticals (ISIS). News For ISIS;SNY From The Last 14 Days Check below for free stories on ISIS;SNY the last two weeks. Sign up for a free trial to see the rest of the stories you've been missing. May 21, 2013 07:44 EDT SNY Sachs Associates to host a forum Subscribe for More Information May 20, 2013 17:26 EDT SNY Regeneron, Genentech, Sanofi enter into 'Zaltrap agreement' Subscribe for More Information 11:27 EDT SNY Appeals court reverses, remands patent ruling in Sanofi suit against Mylan, Teva Subscribe for More Information 07:34 EDT ISIS UBS to host a conference Subscribe for More Information May 17, 2013 08:03 EDT SNY Sanofi reports positive topline results from pivotal Phase III Jakarta study Subscribe for More Information 05:18 EDT SNY Sanofi says JAK2 inhibitor for myelofibrosis met primary endpoint Subscribe for More Information May 15, 2013 15:16 EDT SNY Sanofi systemic sclerosis treatment designated for orphan drug status Subscribe for More Information 05:39 EDT SNY Sanofi, Regeneron announce patient enrollment in two Phase 3 trials Subscribe for More Information May 13, 2013 09:44 EDT SNY Several companies reportedly interested in buying Adcock Ingram, Globes says Subscribe for More Information 07:30 EDT SNY TechConnect to host a summit 2013 National Innovation Summit is being held in Washington, D.C. on May 12-16. May 10, 2013 11:48 EDT SNY Drugmakers to face pressure on U.S. prices, Reuters says Subscribe for More Information May 9, 2013 16:59 EDT ISIS Isis Pharmaceuticals earns $3.5M from Biogen Subscribe for More Information 11:15 EDT ISIS High option volume stocks: BKS ISIS BRY GMCR JOE 06:16 EDT ISIS Isis Pharmaceuticals 9M share Secondary priced at $19.00 Subscribe for More Information Sign up for a free trial to see the rest of the stories you've been missing.