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Recent Posts
- Blog: Waller Law BlogMetro Nashville Beer Board announced temporary beer permit chargePosted on September 19, 2018 by William T. Cheek III
- Blog: Ireland IP & Technology Law BlogICO receiving 500 breach notification calls a weekPosted on September 18, 2018 by Davinia BrennanOn 12 September 2018, the UK Deputy Information Commissioner, James Dipple-Johnstone, made a speech to the CBI Cyber Security: Business Insight Conference in which he discussed recent data breach reporting trends in the UK. The Deputy Commissioner noted that since the GDPR came into effect on 25 May 2018, the ICO has received approximately 500 calls per week to...Continue Reading…
- Blog: Homeostasis: Dykema's Health Care Law BlogReading the Tea Leaves: Understanding OIG PrioritiesPosted on September 12, 2018 by Gerald L. AbenThe 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:
- 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 [...]
- Blog: EndpointsFormer FDA Counsel Joins Verrill Dana’s Health Care GroupPosted on July 16, 2018 by Academic and Clinical Research GroupWe 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 [...]
