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Results: 1-10 of 1,140

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal


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


Snack Bar Class Action is KIND-ly Stayed Pending USDA Regulation on Bioengineered Food
  • Proskauer Rose LLP
  • USA
  • March 26 2018

Earlier this month, Judge William H. Pauley III in the Southern District of New York stayed a lawsuit against the snack bar maker KIND LLC, styled as


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 Drug Marketing Reports Due February 14, 2018
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 12 2018

On February 5, 2018, FDA released a reminder that NDA and ANDA holders’ one-time reports on marketing status under the FDA Reauthorization Act of 2017


Louisiana Adopts Price Reporting Law
  • Kelley Drye & Warren LLP
  • USA
  • November 13 2017

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines


FDA Issues New Guidance on E-Cigarette Free Samples
  • Klein Moynihan Turco LLP
  • USA
  • October 18 2017

Last week, the Food and Drug Administration (“FDA”) issued finalized guidance regarding the distribution of free samples of e-cigarettes and other


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


Fraud on the FDA? If Not Preempted, It Is Trumpery
  • Reed Smith LLP
  • USA
  • October 2 2017

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are


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