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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
Indian pharmaceutical company Dr. Reddy’s will assist in phase 3 clinical trials and distribution in India for Russia’s COVID-19 vaccine, Sputnik V, the company and Russian government announced. Read More
Pfizer reported early safety data yesterday from its phase 3 COVID-19 vaccine trial, saying the vaccine prompted mostly mild to moderate adverse reactions in patients. Read More
A COVID-19 vaccine won’t be widely available nationwide until late in the second quarter or in the third quarter of 2021, Robert Redfield, director of the Centers for Disease Control and Prevention (CDC), said yesterday at a subcommittee hearing of the Senate Appropriations Committee. But President Trump disputes that timeline. Read More
A mid-stage trial of Eli Lilly’s neutralizing COVID-19 monoclonal antibody LY-CoV555 found that the drug reduced the risk of hospitalization in mild-to-moderate COVID-19 patients by 72 percent compared to a placebo. Read More
Health regulators abroad have begun giving the OK for AstraZeneca to resume its phase 3 COVID-19 vaccine trial following a single unexplained patient illness, but the FDA has still not cleared the trial to start back up, with FDA Commissioner Stephen Hahn saying the agency will engage in “very significant work” with the company to unravel the safety issue. Read More