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  • Blog: Waller Law BlogMetro Nashville Beer Board announced temporary beer permit chargePosted on September 19, 2018 by William T. Cheek III
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  • Blog: Homeostasis: Dykema's Health Care Law BlogReading the Tea Leaves: Understanding OIG PrioritiesPosted on September 12, 2018 by Gerald L. Aben
    The Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”) issues work plans (“Work Plan”) that addresses priority areas and emerging issues. For many years, the OIG published its Work Plan every two years with intermediate updates published once or twice each calendar year. Beginning on June 15, 2017, however, the OIG changed its practice and publishes the Work Plan on a monthly basis. These monthly updates are published through the OIG’s Work Plan website. Read More › Tags:
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  • Blog: Biologics BlogNew Arguments in Momenta On Standing to Appeal IPR Loss Before Filing a Biosimilar ApplicationPosted on September 11, 2018 by
    In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a formulation of Orencia® (abatacept) in an IPR brought by Momenta before having filed a biosimilar marketing application.  The Federal Circuit is [...]
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  • Blog: Haynes and Boone BlogsEligible Recipients of Incentive Stock OptionsPosted on September 11, 2018 by Haynes and Boone Benefits Group
    Granting “incentive stock options” qualifying under Section 422 of the Internal Revenue Code (“ISOs”) can often result in more favorable tax treatment to the recipient, provided that the recipient holds the option and the optioned shares for the required period of time. When granting ISOs, it is important to make sure that the plan document […] The post Eligible Recipients of Incentive Stock Options appeared first on Haynes and Boone Blogs.
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  • Blog: EndpointsFormer FDA Counsel Joins Verrill Dana’s Health Care GroupPosted on July 16, 2018 by Academic and Clinical Research Group
    We are pleased to welcome attorney Katlin McKelvie Backfield to our nationally recognized Health Care Group. Katlin comes to Verrill Dana with more than 15 years of pharmaceutical regulatory experience, including more than a decade at the Food and Drug Administration. While at the FDA, Katlin served as Associate Chief Counsel for Drugs in the Office of Chief Counsel and as a Regulatory Counsel in the Division of Drug Marketing, Advertising, and Communications (DDMAC) (now the Office of Prescription Drug Promotion). Prior to joining [...]
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