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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
Participation of women in clinical trials of drugs approved by the FDA increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, but ethnic diversity in trials overall remained steady, according to the agency’s latest Drug Trials Snapshot Summary Report. 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
Drugs approved through the FDA’s Unapproved Drug Initiative could potentially cost $29 billion in extra healthcare costs, Vizient said in a new analysis released this week. 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 FDA issued a warning letter to a Yibin, Sichuan API manufacturer for serious recordkeeping violations related to its crude heparin manufacturing operations. 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