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A proposal to extend the market exclusivity of new drugs approved in India from four years to 10 is dividing the industry, as some argue that the measure would promote safety and others contend it delays generic competition. Read More
The formal process for disputing a patent before the U.S. Patent and Trademark Office skirts statutory requirements and provides drugmakers with an unfair proceeding that skews outcomes, industry said. Read More
A federal judge in New Jersey has ruled that Merck’s patent infringement lawsuit against generic drug manufacturer Fresenius Kabi can proceed. Read More
The Federal Trade Commission is backing Mylan in its request for a rehearing before a panel of appellate court judges on the dismissal of the company’s antitrust case against Warner Chilcott and Mayne Pharmaceuticals. Read More
The FDA and HHS have not responded to a senator’s demand to clarify their enforcement stance on state right-to-try laws that expand terminal patients’ access to unapproved drug therapies, more than 30 days after a hearing on the issue. Read More
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) are pressing Ariad Pharmaceuticals for answers about why the price of a cancer drug it produces has increased more than $80,000 for a year of treatment. Read More
The National Academy for State Health Policy is proposing 10 measures to reduce drug spending, which include greater transparency on pricing and better enforcement of antitrust laws. Read More