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Results: 1-10 of 8,650

FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition
  • Mintz Levin
  • USA
  • July 19 2018

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug


Second Circuit’s Mandate Rule Limits New Causation Theories on Remand
  • McDermott Will & Emery
  • USA
  • July 18 2018

On remand, indirect purchasers of the drug ACTOS sought to amend their antitrust complaint to modify their causal theory of harm. The district court


How Many Infringers Does It Take to “Administer” a Medication?
  • McDermott Will & Emery
  • USA
  • July 18 2018

Addressing the issue of whether defendant's abbreviated new drug application (ANDA) formulation would infringe plaintiff's method patents under a


Teva’s Skinny Label Found Not to Induce Infringement by Off-Label Use
  • McDermott Will & Emery
  • USA
  • July 18 2018

The US District Court for the District of Delaware granted in part Teva Pharmaceuticals' renewed motion for judgment as a matter of law (JMOL


FDA withdraws draft guidance for industry: statistical approaches to evaluate analytical similarity
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 18 2018

On June 21, 2018, the Food and Drug Administration (FDA) withdrew its draft Guidance for Industry entitled “Statistical Approaches to Evaluate


Stability of Ready-to-Use Dexmedetomidine Not Inherent
  • McDermott Will & Emery
  • USA
  • July 18 2018

After a bench trial, the US District Court for the District of Delaware found several Hospira patents covering a diluted, "ready-to-use" composition


Hemp-Derived CBD Prohibited in Food Products in California
  • Greenspoon Marder LLP
  • USA
  • July 17 2018

On July 6, 2018, the California Department of Public Health’s Food and Drug Branch (CDPH-FDB) quietly posted an updated FAQ on cannabidiol (CBD) in


FDA Draft Guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 17 2018

On July 3, 2018, the FDA issued draft guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products. The


FDA Warns of Illegal Online Pharmacies Sending Fake FDA Warning Letters Instead of Medicines to Would Be Customers
  • Keller and Heckman LLP
  • USA
  • July 16 2018

The U.S. Food and Drug Administration is warning consumers about criminals forging FDA Warning Letters to target individuals who tried to purchase


DOJ Announces Revised Opioid Anti-Diversion Policy
  • FisherBroyles LLP
  • USA
  • July 16 2018

Last week, the Department of Justice (DOJ) announced that it had finalized new rules to prevent the diversion of prescription opioids in a move