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Home » Topics » COVID-19

COVID-19
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EMA Reviewing Remdesivir for COVID-19 Patients Who Don’t Require Supplemental Oxygen

February 24, 2021
The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen. Read More

Pfizer Requiring Some Latin American Nations to Put Up Assets in Exchange for Vaccine Deals, Report Says

February 24, 2021
Pfizer has allegedly demanded that certain Latin American governments put up assets as collateral in order to secure supply deals of its COVID-19 vaccine, a nonprofit investigative news organization in the UK has claimed. Read More

FDA Drug Recalls Rise in 2020, New Report Says

February 24, 2021
Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Read More

Coronavirus Vaccine Makers Testify Before House Subcommittee, Promise Supply Boost

February 24, 2021
COVID-19 vaccine makers appearing yesterday before a U.S. House subcommittee pledged to lawmakers they would meet — and in some cases accelerate — their vaccine supply commitments, as the federal government and states clamor for more doses one year into the pandemic. Read More
CE mark

Cue Health’s COVID-19 Test Receives CE Mark

February 24, 2021
The test consists of a single-use test cartridge, a lower nasal swab and a reusable, battery-powered cartridge reader that delivers the results to the mobile app. Read More

Fujifilm May Restart Avigan Trial for COVID-19

February 23, 2021
Fujifilm is reportedly considering restarting a study evaluating its antiviral Avigan (favipiravir) for treating COVID-19 patients, after the drug suffered a setback in late 2020. Read More

COVID-19 Relief Bill Clears House Budget Committee

February 23, 2021
The House Budget Committee yesterday cleared the pending $1.9 trillion COVID-19 relief legislation, which includes a one-time $500 million in additional FDA funding for coronavirus-related support, paving the way for the bill to be taken up by the House Rules Committee later this week. Read More

GSK, Sanofi Kick Off Phase 2 Vaccine Trial Following December Delay

February 23, 2021
GlaxoSmithKline (GSK) and Sanofi have launched a phase 2 study evaluating their adjuvanted recombinant COVID-19 candidate, after delaying the trial by more than two months. Read More

Novavax Finishes Enrollment for U.S. Phase 3 COVID-19 Vaccine Trial

February 23, 2021
Novavax has announced that it has completed enrolling 30,000 participants in its late-stage U.S./Mexico pivotal trial of its COVID-19 vaccine, bringing its recombinant protein-based vaccine hopeful one step closer to potential FDA authorization. Read More

FDA Outlines Data Required for Modifying COVID-19 Vaccines Against Viral Variants

February 23, 2021
The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending Emergency Use Authorizations (EUAs), noting that it doesn’t expect large-scale trials will be needed for the altered versions. Read More
Partner Up, blocks

Becton Dickinson, Scanwell Health Partnering on COVID-19 Rapid Home Test

February 23, 2021
The companies said they are working on enabling the test to automatically report results to public health agencies. Read More

J&J Files for WHO Emergency Use Listing of Its COVID-19 Vaccine

February 22, 2021
Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program. Read More
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