Incyte announced results of phase 3 study of Ruxolitinib (Jakafi) as treatment for patients with COVID-19 associated cytokine storm
On Dec. 14, 2020, Incyte announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of…
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Moderna confirmed supply agreement to supply Singapore with mRNA vaccine against COVID-19
On Dec. 14, 2020, Moderna confirmed that the Company had concluded an agreement with the Ministry of Health…
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Data from phase 1/2 study further characterized immune response with lead COVID-19 vaccine candidate
On Dec. 14, 2020, Pfizer and BioNTech announced additional data on neutralizing antibody and T cell responses from…
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Antibody study suggested COVID-19 infections underestimated
On Dec. 14, 2020, a months long study to determine the number of Houstonians carrying COVID-19 antibodies revealed…
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FDA approved first intentional genomic alteration in domestic pigs for both human food, potential therapeutic uses
On Dec. 14, 2020, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in…
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AstraZeneca acquired Alexion Corp for $39 billion
On Dec. 12, 2020, AstraZeneca and Alexion Pharmaceuticals announced an agreement for AstraZeneca to acquire Alexion. Alexion shareholders…
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CDC’s ACIP issued interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in persons aged =16 years for prevention of COVID-19.
On Dec. 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of…
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Amarin reported encouraging efficacy and safety results from VASCEPA pilot study treating COVID-19 infected outpatients
On Dec. 12, 2020, Amarin announced clinical results from the CardioLink-9 Trial, the first results of a study…
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CDC recommended vaccination with Pfizer and BioNTech COVID-19 vaccine for ages 16 years and older
On Dec. 12, 2020, Pfizer and BioNTech announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted…
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US FDA issued Emergency Use Authorization for first COVID-19 vaccine
On Dec. 11, 2020, the FDA issued the first emergency use authorization (EUA) for a vaccine for the…
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Baricitinib plus remdesivir showed promise for treating COVID-19
On Dec. 11, 2020, the combination of baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, reduced time to…
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AI test ruled out a COVID-19 diagnosis within one hour in Emergency Departments
On Dev. 11, 2020, the University of Oxford reported that an Artificial Intelligence test had been shown to…
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UK COVID-19 infections survey revealed changes to pandemic over time
On Dev. 11, 2020, the University of Oxford reported that data from the National COVID-19 Infection Survey, done…
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COVID-19 | FDA | Therapeutics
Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJM
On Dec. 11, 2020, Eli Lilly and Incyte announced The New England Journal of Medicine had published the…
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USDA confirmed COVID-19 in a snow leopard at a Kentucky zoo
On Dec. 11, 2020, the USDA’s National Veterinary Services Laboratories announced the first confirmed case of SARS-CoV-2 (the…
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U.S. Government exercised 1st option for additional 100 million doses of Moderna’s COVID-19 vaccine
On Dec. 11, 2020, Moderna announced that the U.S. government has exercised its option to purchase an additional…
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GABA-enriched tomato first CRISPR-edited food to enter market launched in Japan
On Dec. 11, 2020, Sanatech Seed Co, and sales partner Pioneer EcoScience, announced the commercial sales of Sicilian…
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US Dept of Veterans Affairs announced initial plans for COVID-19 vaccine distribution
On Dec. 10, 2020, the U.S. Dept. of Veterans Affairs (VA) announced a preliminary plan for distributing COVID-19…
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Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 10, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
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European CHMP adopted positive opinion for HEPLISAV-Bﾮ hepatitis B adjuvanted vaccine
On Dec. 10, 2020, Dynavax Technologies announced that the European Medicines Agency (EMA) Committee for Medicinal Products for…
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ImmunityBio’s hAd5 T-Cell COVID-19 vaccine candidate showed complete protection of airways
On Dec. 10, 2020, ImmunityBio announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates…
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Moderna announced first participants dosed in phase 2/3 study of COVID-19 vaccine candidate in adolescents
On Dec. 10, 2020, Moderna announced that the first adolescent participants had been dosed in the Phase 2/3…
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Pfizer and BioNTech received FDA Advisory Committee vote supporting EUA for COVID-19 vaccine in the US
On Dec. 10, 2020, Pfizer and BioNTech announced that the FDA Vaccines and Related Biological Products Advisory Committee…
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Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 9, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
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LabCorp received FDA Authorization to make at-home COVID-19 collection kits available rhrough retail
On Dec. 9, 2020, LabCorp announced that the FDA had granted Emergency Use Authorization (EUA) for the Pixel…
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Virologist Michael Houghton awarded Nobel Prize in Physiology or Medicine for the discovery of Hepatitis C virus
On Dec. 8, 2020, University of Alberta virologist Michael Houghton was awarded a share of the 2020 Nobel…
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First peer-reviewed results of phase 3 human trials of University of Oxford vaccine demonstrated efficacy
On Dev. 8, 2020, University of Oxford and AstraZeneca researchers present a pooled analysis of Phase 3 trials…
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Switzerland exercised increased option for 7.5 million doses of mRNA vaccine against COVID-19 (mRNA-1273)
On Dec. 8, 2020, Moderna announced the Swiss Federal Government had increased its confirmed order commitment from 4.5…
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FDA accepted for priority review the BLA for Pfizerﾒs investigational 20-valent pneumococcal conjugate vaccine
On Dec. 8, 2020, Pfizer announced that the FDA accepted for priority review a Biologics License Application (BLA)…
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Chimerix announced FDA acceptance of NDA for brincidofovir as a medical countermeasure for smallpox
On Dec. 7, 2020, Chimerix announced the U.S. Food and Drug Administration (FDA) had accepted the filing of a…
