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Washington state oncology drug developer OncoGenex is taking back rights to the experimental cancer therapy custirsen, ending a five-year collaboration with Israeli manufacturer Teva Pharmaceuticals. Read More
In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing. Read More
China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform, regardless of port of entry. Read More
TWi Pharmaceuticals’ bid to market a generic version of Par Pharmaceutical’s AIDS drug Megace ES was dealt a major blow last month after a federal appeals court overturned a lower court’s ruling that had cleared the way for the product. Read More
A leaked draft of the Trans Pacific Partnership trade agreement gives far too much intellectual property protection to brand drugmakers at the cost of generic competition, GPhA says in a letter to the Obama administration. Read More
A federal judge has ordered Actavis to keep the original version of its blockbuster Alzheimer’s therapy Namenda on the market while the court hears an ongoing antitrust lawsuit that claims the drugmaker wants to pull the older version to hinder generic competition. Read More
For the first time, a brand drugmaker has defeated a generics firm’s patent challenge through the U.S. Patent and Trademark Office’s internal review board process, which started in 2012. Read More
Sandoz’s bid to invalidate two patents protecting Amgen’s biologic rheumatoid arthritis therapy Enbrel was dealt a major blow last month after a federal appeals court affirmed that a patent challenge prior to submission of a biosimilar application is premature. Read More
China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More
Actavis must keep its Alzheimer’s drug Namenda on the market for now, but a recent agreement with the New York Attorney General will let the company avoid notifying more than half a million people of that fact. Read More