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Results: 1-10 of 173

FDA Releases Stem Cell Guidance Documents
  • Foley & Lardner LLP
  • USA
  • November 27 2017

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing


Three Years Later, Foley Survey Reveals Positive Prognosis for Telemedicine
  • Foley & Lardner LLP
  • USA
  • November 15 2017

When we launched Foley’s inaugural Telemedicine and Digital Health Survey in 2014, it was apparent that health care executives weren’t ready to make


2017 Telemedicine and Digital Health Survey
  • Foley & Lardner LLP
  • USA
  • November 15 2017

Fueled by surging demand among patients and providers, telemedicine is spreading rapidly throughout the health care system, according to the 2017


FDA Draft Guidance on Menu Labeling
  • Foley & Lardner LLP
  • USA
  • November 10 2017

On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants


Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name
  • Foley & Lardner LLP
  • USA
  • November 8 2017

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and


FDA Approves Companion Dx for PD-1 Inhibitor
  • Foley & Lardner LLP
  • USA
  • October 11 2017

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and


FDA Marketing Exclusivity Periods Limited To Same Active Moiety
  • Foley & Lardner LLP
  • USA
  • September 7 2017

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed


How Companies Should Prep for Enforcement Shift to State AGs
  • Foley & Lardner LLP
  • USA
  • August 23 2017

“Top Cop” is how every state Attorney General wants to be known. In reality, state AGs have far more authority for civil enforcement than they do for


Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis
  • Foley & Lardner LLP
  • USA
  • July 25 2017

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange


USPTO Extends Cancer Immunotherapy Pilot Program
  • Foley & Lardner LLP
  • USA
  • June 26 2017

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to