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The FDA issued a warning letter to an Oklahoma drug manufacturer Kalchem International for active pharmaceutical ingredient (API) labeling failures, a lack of API oversight, and other violations. Read More
Eli Lilly has entered into a global partnership with Amgen to increase supply capacity for Eli Lilly’s neutralizing antibodies as a treatment for COVID-19 patients. Read More
The National Institutes of Health (NIH) has launched a phase 2 clinical trial of Rigel Pharmaceuticals’ fostamatinib for the treatment of hospitalized COVID-19 patients. Read More
The Center for American Progress (CAP), a Democrat-aligned think tank, issued a report Thursday recommending how the next president could lower drug prices, such as by leveraging existing laws to break up drug monopolies. Read More
FDA’s Office of Prescription Drug Promotion (ODOP) slapped Sprout Pharmaceuticals with a warning letter over the misbranding of its drug Addyi (flibanserin) in a direct-to-consumer radio ad. Read More
More than 240 bipartisan lawmakers wrote to HHS Secretary Alex Azar this week urging the department to take immediate action to stop drugmakers from discontinuing or greatly altering the discounts they provide to safety-net hospitals as required under the 340B Drug Pricing Program. Read More
New York State’s surcharge on opioid drug manufacturers to help pay for the costs of the opioid drug abuse epidemic is a constitutional tax, the U.S. Court of Appeals for the Second Circuit ruled Sept. 14. Read More