Archive for September 2020

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

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

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

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

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 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

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

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

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