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Results:1-10 of 308

Pathways to Approval: Recent Developments in EU Pharma and Medical Device Regulation
  • McDermott Will & Emery
  • USA, European Union
  • December 26 2018

The contrast between the United States and European Union is no more apparent than when we consider the approach to centralized


Risky Business: Due Diligence for Early-Stage Life Sciences Companies
  • McDermott Will & Emery
  • USA
  • December 26 2018

The life sciences industry has changed dramatically over the last 10 years: cancer treatments using a patient’s own immune system to selectively kill


FDA Issues Real-World Evidence Framework for Drugs and Biologics
  • McDermott Will & Emery
  • USA
  • December 12 2018

On December 6, 2018, Commissioner Scott Gottlieb announced the FDA’s highly anticipated new strategic framework for assessing the potential


FTC Submits Comment on FDA Guidance Aimed at Deterring Abuse of Citizen Petition Process
  • McDermott Will & Emery
  • USA
  • December 11 2018

The Federal Trade Commission (FTC) submitted comments supporting the Food and Drug Administration’s (FDA) guidance for assessing whether a


OIG Dusts off the Old Rule Book to Say No to Free Expensive Drugs to Hospitals
  • McDermott Will & Emery
  • USA
  • December 10 2018

The Office of Inspector General, Department of Health and Human Services posted an unusual negative Advisory Opinion (AO 18-14) on a drug company’s


“Blocking Patent” Deterrence Effect May Discount Secondary Considerations for Follow-On Patents
  • McDermott Will & Emery
  • USA
  • October 24 2018

The US Court of Appeals for the Federal Circuit affirmed a district court's obviousness determination, finding that a patentee's exclusive


Creating Abuse-Resistant Treatments for Opioid Dependence Is Not So Obvious After All
  • McDermott Will & Emery
  • USA
  • October 24 2018

In a case involving abuse-resistant pharmaceutical compositions for the treatment of opioid dependence, the US Court of Appeals for the Federal


DEA Schedules a FDA-Approved CBD Drug
  • McDermott Will & Emery
  • USA
  • October 5 2018

As beverage manufacturers mull the creation and distribution of cannabidiol (CBD)-infused products, the US Drug Enforcement Administration’s (DEA)


Printed Publication Status Based on Public Accessibility
  • McDermott Will & Emery
  • USA
  • August 30 2018

Addressing public accessibility of prior art, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB)


Obviousness Cannot Be Predicated on What Is Unknown
  • McDermott Will & Emery
  • USA
  • August 30 2018

The US Court of Appeals for the Federal Circuit upheld a district court finding that the patent challenger failed to prove that patents directed to a