Top of the morning to you, and a fine one it is. A shiny sun and cool breezes are enveloping the Pharmalot campus, where the short person is sleeping in and the official mascot is searching for things to chew on. This means we are free to fire up the coffee kettle and brew another cup of stimulation. The neurons need all the help they can get, you know? Meanwhile, here are a few items of interest to help you get going. And by the way, we are hosting a chat today at 1 p.m. ET to discuss the state of the pharmaceutical industry, such as it is. So turn on and tune in. Meanwhile, have a great day …
The FDA plans to release guidance outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the virus, The Wall Street Journal reports. No vaccine would be approved unless a company “clearly demonstrated” proof of safety and effectiveness through a clinical study, and would not be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.
Drug makers raised prices on 245 drugs since the first U.S. Covid-19 case was reported on Jan. 20, The Hill writes, citing a report released by an advocacy group. Of the price hikes, 61 were for drugs being used to treat the virus and 30 are in clinical trials. The price hikes are on par with increases the previous two years. The report found that 44 inpatient drugs have seen price increases during the pandemic, including 20 drugs commonly used in intensive care units: sedatives, steroids, blood pressure medications, and blood thinners.
Huzzah, if true!? FDA is NOT looking for a secondary endpoint with a COVID-19 vaccine: “would not be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.”
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