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Posts Tagged: fda


Nothing clarified the stakes in orphan drug development like hearing Ron Bartek describe how after 16 years a promising treatment for his son’s disease finally emerged with TRND’s help. The therapy demonstrated enough potential that it was licensed …

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The Supreme Court reversed a decision from the Ninth Circuit that held that within the realm of labeling for food and beverages, a Lanham Act claim asserting that the label is deceptive and misleading is precluded by the Federal …

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What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. Supreme Court Denies Teva's Request for an Injunction Relating to Generic Copaxone® --- Actavis Announces Celebrex® Patent …

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Mylan Inc. (NASDAQ: MYL) recently prevailed in the United States District Court for the Northern District of West Virginia in a patent dispute involving Perforomist® (formoterol fumarate) Inhalation Solution, which has as the active ingredient a bronchodialating compound. The …

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The Court will hear oral argument as follows: on February 26, in two cases on granting (Octane Fitness) and reviewing (Highmark) attorneys’ fee awards; on March 31, in a case (Alice Corp.) on patent eligibility of system and computer-implemented method claims; …

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Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** Favorable Markman Ruling for Dopomed in GRALISE® Patent Litigation *** More FDA Woes …

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Mouse Model of Parkinson's Disease Shows Improved Brain Function --- DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™ --- Actavis Files ANDA for Generic Suboxone® Sublingual Film --- AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz --- Surgeons …

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1. Reed Tech takes over USPTO Contract from Google. 2. Pharma Patent Settlements Saved $25.5 Billion for US Health System. 3. Coffee Analysis Smart Phone App for that Perfect Brew. 4.FDA Approves Brain Wave Test to Assess ADHD in Children. 5. CAFC Copaxone® Patent …

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The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become …

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This newly approved, updated prescribing information for ISENTERSS now includes 240-week results from the STARTMRK study, the double-blind Phase III study that evaluated integrase inhibitor in previously untreated adult patients with HIV-1 infection. The results show that the regimen …

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A variety of electronic cigarettes have hit the market in recent months, and lately it seems that I am seeing a lot of electronic cigarette commercials on TV. Last week ICAP Patent Brokerage announced that it would be selling …

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After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal. The decision largely vindicates the position …

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