Food and Drug Administration staff lifts security worries over Lilly/Incyte arthritis drug

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FILE picture - A view shows the U.S. FDA (FDA) headquarters in Silver Spring, Maryland August 14, 2012. security information supported a reduce two mg dose of the drug, baricitinib, however not a four mg dose, raising questions whether the higher dose provides extra benefit, the staffers said. Evercore ISI analyst Josh Schimmer said questions over the doses can result in an "awkward" label for the drug. Baricitinib is a once-daily pill that belongs to a class of drugs known as JAK inhibitors, that work with blocking inflammation-causing enzymes known as Janus kinases. "This can be a positive for competitors like AbbVie & Gilead & Galapagos that have their own oral JAK inhibitors in late-phase Growth," wrote Credit Suisse analysts.


Food and Drug Administration committee recommends premier marijuana-derived drug

(CNN) A America FDA advisory committee on Thursday unanimously recommended consent of an epilepsy drug which would be the premier plant-derived cannabidiol medicine for prescription Utilize in the U.S.. The FDA going to vote in June whether to confirm the drug, Epidiolex, an oral solution, for the curing of severe forms of epilepsy in a small group of patients. "We're obviously sopleased with the unanimous recommendation in backing of the consent of Epidiolex," GW chief executive officerJustin Gover said. Though FDA consent would limit Utilize of the drug to epilepsy patients, doctors would have the option to prescribe it "off-label" for other Utilizes. Though the FDA stressed which description of Epidiolex going to be ongoing, Gover said he feels confident about a positive outcome.

FDA committee recommends first marijuana-derived drug

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collected by :Lucy William

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