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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
The Federal Trade Commission counted 29 pay-for-delay deals in fiscal year 2013 out of a total of 145 patent litigation settlements between brand and generic drugmakers — a slight decline from 2012, but in line with the two previous years. 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
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 said Wednesday in a letter to the Obama administration. Read More