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1

Trump, pressured over pandemic, says states will receive 150 million tests

President Donald Trump, under fire over his handling of the coronavirus epidemic, announced that the federal government would ship 150 million rapid tests to U.S. states and warned an increase in positive cases is likely in the days ahead.

4

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.

5

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.

7

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).

10

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.