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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
The court still has to determine whether the executives are jointly liable for the amount, or if it will be apportioned between the defendants Read More
FDA Commissioner Stephen Hahn warned that consumers in the U.S. face potential risks when they order pharmaceutical products from unauthorized manufacturers abroad. Read More
The first U.S. clinical trial of a treatment for COVID-19 — Gilead’s antiviral remdesivir — has begun at the University of Nebraska Medical Center in Omaha. Read More
Mallinckrodt announced a $1.6 billion settlement with 47 U.S. states and territories for its role in the nation’s opioid crisis, in a deal that involves the bankruptcy of its generics unit. Read More
The White House has asked Congress for $2.5 billion in emergency funding to support the government’s response to the coronavirus outbreak — including more than a billion dollars for vaccine development — as a senior CDC official predicted a “community spread” of the virus in the U.S. Read More