In May of 2010, the FDA turned down a drug by InterMune (NASDAQ:ITMN) and three members of an independent advisory panel say that they had as much as a day’s notice before the rejection, an admission that is now linked with an insider trading probe of SAC Capital Advisors. On the day before the official announcement, InterMune shares dropped 5.4 percent on the day, during which the panel members know that the drug was doomed. However, others at the firm and at the FDA were also aware of the rejection, but there is no evidence the 11 panelists did anything inproper.
On Wednesday, Depomed (NASDAQ:DEPO) said that its lawsuits against two filers of Abbreviated New Drug Applications for Gralise (gabapentin) have been dismissed, as Watson Laboratories (NYSE:WPI) has withdrawn its Gralise ANDA. Also, Par Pharmaceutical has modified its Gralise ANDA and no longer seeks approval of the ANDA, prior to the expiry of Depomed’s patents listed for Gralise in the FDA’s Orange Book. Therefore, the United States District Court for New Jersey has awarded the parties’ request for dismissal of Depomed’s lawsuits against Watson and Par. However, Depomed’s patent litigation against the remaining three Gralise ANDA filers continues.
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Pfizer (NYSE:PFE) and Bristol-Myers Squibb Company said that the Ministry of Health, Labor and Welfare of Japan has cleared Eliquis for the prevention of ischemic stroke and systemic embolism in patients suffering from nonvalvular atrial fibrillation. The drug is a novel anticoagulant that has shown risk reductions compared to warfarin in three important outcomes of stroke, major bleeding and all-cause death. Eliquis is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. This marks the third approval for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation following approvals in the European Union and Canada.
On Thursday, Oculus Innovative Sciences (NASDAQ:OCLS) announced the issuance of a new United States patent for the use of Microcyn Technology for the treatment of skin ulcers which can be delivered by washing, irrigation and soaking or through the application of a wound dressing saturated in the Microcyn technology. Oculus is a healthcare firm that designs, makes and markets innovative, safe and effective anti-infective products and medical devices while concurrently developing multiple drug candidate.
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