We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 1,230

FDA schedules public hearing on solutions to drug shortages
  • Hogan Lovells
  • USA
  • October 8 2018

FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a


Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come


PTAB Upholds GILENYA Method of Treatment Patent, Prompting New ANDA Litigation
  • Jones Day
  • USA
  • July 30 2018

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not


A Petitioner’s Dilemma in Post-Grant Reviews
  • K&L Gates
  • USA
  • June 5 2018

Post-grant reviews ("PGRs") can only be filed within a nine-month window starting from the issuance of the patent, but standing to appeal to the


Hospitals Face Sizable Overpayment Liability for Not Reporting Medical Device Credits
  • Nelson Mullins Riley & Scarborough LLP
  • USA
  • April 9 2018

The Office of Inspector General (OIG) continues to unearth widespread noncompliance by hospitals with requirements for reporting the receipt of


New CMS Guidance for ADLT Lab Tests and ADLT Application Released
  • Reed Smith LLP
  • USA
  • April 6 2018

CMS is still rolling out policies and procedures to fully implement the major clinical laboratory payment reforms mandated by the Protecting Access to


Federal Right To Try Legislation - Is It Any Better? - 2018 Edition
  • Reed Smith LLP
  • USA
  • March 23 2018

A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of


Connected medical device vulnerabilities continue to impact manufacturers, health care
  • Thompson Coburn LLP
  • USA
  • March 22 2018

Recently, Thompson Coburn’s Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging


Drug Price Transparency Bill Enacted in Oregon
  • Cooley LLP
  • USA
  • March 14 2018

The Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers


Efforts to Cut Drug Prices in Medicaid
  • Manatt Phelps & Phillips LLP
  • USA
  • February 27 2018

Over the past five years, the budgets of state Medicaid programs have been challenged by the introduction of new high-cost drugs into the marketplace