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Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • April 3 2018

Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee, received marketing approval from

Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”
  • Marshall Gerstein & Borun LLP
  • USA
  • March 26 2018

A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen

Oregon Joins Growing Number of States with New Drug Pricing Transparency Laws
  • Arent Fox LLP
  • USA
  • March 21 2018

Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California, Nevada, and Maryland, which

Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • March 15 2018

A structured guide to clinical trials in China

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

FDA Draft Guidance Proposes Risk-Based Regulatory Scheme for Drug Products Labeled as Homeopathic
  • Haynes and Boone LLP
  • USA
  • March 12 2018

More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for

FDA Guidance on Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 6 2018

On March 2, 2018, FDA issued draft guidance on the definitions of “suspect product” and “illegitimate product” for verification obligations under the

FDA Draft Guidance on Developing Drugs for Early Alzheimer’s Disease
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 27 2018

On February 16, 2018, FDA issued draft guidance on Early Alzheimer’s Disease (AD): Developing Drugs for Treatment. This draft guidance revises the

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

Opening Brief Filed in Deeming Rule Appeal by Nicopure Labs and the Right to be Smoke-Free Coalition
  • Keller and Heckman LLP
  • USA
  • February 14 2018

On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the Appellants) filed their opening brief in the appeal of last