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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
The FDA should seek authority from Congress to require drug companies to disclose the “complete physical path” of products through the supply chain, HHS Office of Inspector General (OIG) recommended in a new report. Read More
FDA Commissioner Stephen Hahn yesterday said the agency has identified 20 products that are either made in finished-dosed or source their active pharmaceutical ingredients solely in China. The agency has reached out to the 183 drugmakers in China and none have reported shortages tied to the COVID-19 outbreak so far, he said. Read More
The FDA’s Oncologic Drugs Advisory Committee split on the benefit-risk profile for Eli Lilly’s monoclonal antibody Cyramza (ramucirumab), voting 6-5 in favor of the drug for patients with untreated metastatic EGFR-positive non-small cell lung cancer. Read More
The Institute for Clinical and Economic Review (ICER) has gone back on its initial value assessment for two of three acute migraine treatments, finding after a second look that the drugs may be cost-effective after all. Read More