Devices & Diagnostics Letter
HHS Says Memo Won’t Take Power From the FDA
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
Read MoreState Treasurers Accuse Gilead of Seeking ‘Unreasonable Profits’ From Remdesivir
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
Read MoreRussian COVID-19 Therapeutic Coronavir to Hit Pharmacy Shelves in Coming Days
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
Read MoreEU Signs COVID-19 Vaccine Supply Deal With Sanofi/GSK
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
Read MoreEMA Expert Group Recommends Dexamethasone for COVID-19
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
Read MoreRoche’s Actemra Cuts Ventilator Need in COVID-19 Patients
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
Read MoreLawmakers Lash Out at White House Over Hahn Testimony on COVID-19
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
Read MoreDiaSorin’s COVID-19 Test Gets European OK for Saliva Samples
The direct molecular test received an initial FDA Emergency Use Authorization in March. Source: Devices & Diagnostics Letter
Read MoreAbbott’s Over-the-Counter Sport Glucose Sensor Gains CE Mark
Athletes place the small round biosensor on the back of an upper arm. Source: Devices & Diagnostics Letter
Read MoreTrump Criticizes FDA Delay of Convalescent Plasma EUA
President Trump is lashing out at the FDA’s decision to hold off issuing an Emergency Use Authorization (EUA) for using convalescent plasma to treat COVID-19 patients. Source: Devices & Diagnostics Letter
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