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The FDA’s planned guidance on Emergency Use Authorization (EUA) of COVID-19 vaccines may be released as soon as this week and could include standards making an EUA unlikely before the Nov. 3 presidential election. Read More
Prominent medical journal The Lancet has tightened its publishing requirements for research papers in response to an embarrassing retraction of a study based on questionable data from multiple trials. The journal said it will now require stronger data reviews for papers based on large, real-world datasets. Read More
AstraZeneca has released the trial protocols for the late-stage study of its coronavirus vaccine candidate, AZD1222, amid mounting calls for transparency as its investigation into an adverse event continues. Read More
HHS has clarified that last week’s memo from Secretary Alex Azar will in no way impact the FDA’s decisions on drugs and vaccines although former FDA officials say questions remain. Read More
HHS on Sunday refuted reports that a new departmental memo will take decision-making power away from the FDA regarding the approval of COVID-19 vaccines or therapeutics. Read More
Coronavir, a treatment developed by Russian company R-Pharm for mild-to-moderate COVID-19 infections, is slated to be offered in pharmacies in that country as early as this week. Read More
The corticosteroid dexamethasone has earned the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) for treating COVID-19 patients who require oxygen therapy. Read More
In the European Union’s (EU) latest move to secure supplies of a COVID-19 vaccine, the European Commission (EC) has signed a contract with Sanofi and GlaxoSmithKline (GSK) for 300 million doses of their vaccine candidate. Read More
In a letter to Gilead Sciences, almost a dozen state treasurers accused the company of seeking “unreasonable profits” from its antiviral COVID-19 treatment remdesivir, demanding that it lower the price. Read More
Roche’s late-stage COVID-19 trial of Actemra (tocilizumab) showed the rheumatoid arthritis drug reduced the number of coronavirus patients who progressed to mechanical ventilation, suggesting it might be of benefit as a coronavirus treatment although the drug did not meaningfully lower mortality rates. Read More
Leaders of the House Energy and Commerce committee on Friday lashed out at the Trump administration for allegedly blocking Commissioner Stephen Hahn from testifying about the agency’s COVID-19 response. Read More