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Results:1-10 of 578

CMS Allows Medicare Part D Indication-Based Formulary Design
  • Holland & Knight LLP
  • USA
  • August 30 2018

The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D


House Opioid Measure Frenzy Continues
  • Quarles & Brady LLP
  • USA
  • July 16 2018

Over a period of two weeks in June, the House passed several bills aimed at combating the ongoing opioid epidemic. Our summary of the earlier measures


FDA Issues Two Guidances on Next Generation Sequencing
  • Reed Smith LLP
  • USA
  • April 24 2018

This guest post is from Reed Smith‘s Matt Jacobson, who is keeping us up to date with the FDA’s initiatives concerning pharmacogenomics and


Sandoz’s Challenge to Two of AbbVie’s Humira Patents Denied by PTAB
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • February 26 2018

Sandoz’s request for inter partes review (“IPR”) of U.S. Patent Numbers 9,512,216 (“the ’216 patent”) and 8,802,100 (“the ’100 patent”) was denied by


Will Massachusetts be able to negotiate Medicaid prescription drug prices?
  • Gordon Rees Scully Mansukhani
  • USA
  • January 25 2018

In the absence of new federal policies to tame high price drugs, Massachusetts’ state Medicaid program is fighting for the power to negotiate


Life sciences: product regulation and liability in the USA
  • Perkins Coie LLP
  • USA, Global
  • October 11 2017

A structured guide to product regulation and liability in the USA


California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
  • Cooley LLP
  • USA
  • September 18 2017

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B


Health Hacking: Dealing with the cyber threat in digital health
  • Corrs Chambers Westgarth
  • Australia
  • September 1 2017

Software and the electronic devices it controls, has become increasingly important in the healthcare industry over recent years. Digital health


The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 4
  • Mintz
  • USA
  • August 14 2017

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent


FDA Approves Final Label for Syndros
  • Knobbe Martens
  • USA
  • June 12 2017

On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros (dronabinol) oral solution, a Schedule II (CII)