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Former FDA Commissioner Scott Gottlieb warned of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. The agency reported the first coronavirus-related shortage on February 27 but did not name the product. Read More
Sandoz has agreed to pay $195 million to settle charges related to the Department of Justice’s three-year antitrust investigation into the generic drug industry, the company announced yesterday. Read More
The latest decision ends the drugmakers’ Truvada patent challenges before the board. The matter is now in the hands of the U.S. District Court for the District of Delaware, where HHS has sued the drugmaker for patent infringement. Read More
Opioid makers and 37 Attorneys General told an Ohio federal court that proposed attorney fees could derail a global settlement in the opioid multidistrict litigation. Read More
The FDA unveiled a pilot program last week that will use plain language and podcasts to explain its guidance documents in snapshots posted to its website. Read More
The Council of Economic Advisers estimated that revenues for non-U.S. drugmakers would have been $194 billion higher in 2017 if foreign drug prices reflected the countries’ Gross Domestic Product. Read More
A Kansas federal judge has certified two classes in an antitrust suit against Pfizer and Mylan over an alleged scheme to raise the price of EpiPen (epinephrine injection USP). Read More