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J&J’s Single-Dose Covid-19 Vaccine Generates Strong Immune Response, Early Data Shows

Days after Johnson & Johnson moved JNJ-78436735 into Phase III development, the company posted an interim analysis of a Phase I/IIa trial that showed a single dose of the novel coronavirus vaccine candidate induced a strong neutralizing antibody response in nearly all participants and was well-tolerated.


FDA Action Alert: Aquestive, Eton and Mesoblast

The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.


FDA Approves Fetroja for Treatment of HABP/VABP

The U.S. Food and Drug Administration approved a supplemental New Drug Application for Shionogi & Co. Ltd.’s Fetroja (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).


Positive Covid-19 test rates top 25% in some U.S. Midwest states

The number of tests coming back positive for Covid-19 is topping 25% in several states in the U.S. Midwest as cases and hospitalizations also surge in the region, according to a Reuters analysis.


The Global Cost of Containing Covid-19

Will the solitary path the United States is on, insulate it from further Covid-19 pandemic-related damage? Christopher Snyder, a professor of economics at Dartmouth University, believes the answer depends largely on the eventual vaccine’s level of efficacy.