Minding Your Business

Proskauer’s perspective on developments and trends in commercial litigation.

Tag Archives: Food and Drug Administration (FDA)

Generic Competition for Withdrawn Drug Products

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons. But how does the FDA reach that conclusion? … Continue Reading

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine. This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, … Continue Reading

Bipartisan Congress Intensifies Efforts to Restrict Orphan Drug Exclusivity

“Orphan” drug exclusivity, which is intended to reward drug companies’ investment in the development of certain drugs, might soon be harder to get—and keep. Over the past several months, Congress introduced two similar bills to amend a “loophole” in the Orphan Drug Act (ODA).  On October 17, 2019, a bipartisan group of House members introduced … Continue Reading

Chambers and Partners Releases Pharmaceutical Advertising 2018 Guide

Chambers and Partners released its first ever Pharmaceutical Advertising 2018 guide, authored by Proskauer partners Lawrence Weinstein and Alexander Kaplan with assistance from several litigation associates. The guide provides a comprehensive look at the laws and regulations governing pharmaceutical advertising in various markets, and provides important developments in the most significant jurisdictions and legal commentary on … Continue Reading
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