Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter

The direct molecular test received an initial FDA Emergency Use Authorization in March. Source: Devices & Diagnostics Letter

Athletes place the small round biosensor on the back of an upper arm. Source: Devices & Diagnostics Letter

Sinopharm has announced that it will launch another phase 3 trial of its experimental COVID-19 vaccine candidate, this time in Peru, following a greenlight from the Peruvian health regulator. Source: Devices & Diagnostics Letter