Biotechnology | COVID-19 | FDA
Quidel received EUA for moderately complex Solana SARS molecular test for COVID-19 diagnosis
On Dec. 23, 2020, Quidel announced that it had received Emergency Use Authorization (EUA) from the FDA to…
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Serum Institute of India and Dynavax announced first participants dosed in phase 1/2 clinical trial for COVID-19 vaccine
On Dec. 23, 2020, Serum Institute of India and Dynavax jointly announced that the first participants had been…
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VBI Vaccines announced EMA acceptance of MAA for 3-Antigen prophylactic Hepatitis B vaccine
On Dec. 23, 2020, VBI Vaccines announced that the European Medicines Agency (EMA) has accepted the filing of…
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Health Canada authorized Moderna COVID-19 vaccine in Canada
On Dec. 23, 2020, Moderna announced that Health Canada had authorized its vaccine against COVID-19 for the immunization…
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Altimmune provided an update on investigational New Drug Application for phase 1 AdCOVIDﾙ clinical trial
On Dec. 23, 2020, Altimmune announced that the FDA had issued a clinical hold on the Companyﾒs Investigational…
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Tonix Pharmaceuticals announced commercial scale vaccine manufacturing facility in Hamilton, Montana
On Dec. 23, 2020, Tonix Pharmaceuticals announced that it had completed the purchase of an approximately 44-acre site…
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Pfizer and BioNTech to supply the US with 100 million additional doses of COVID-19 vaccine
On Dec. 23, 2020, Pfizer and BioNTech announced a second agreement with the U.S. government to supply an…
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Mink at affected Oregon farm negative for SARS-CoV-2, wildlife surveillance continued
On Dec. 23, 2020, recent tests confirmed mink that tested positive for SARS-CoV-2 at an Oregon farm in…
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Resverlogix announced apabetalone treatment prior to SARS-CoV-2 exposure reduced viral infection
On Dec. 22, 2020, Resverlogix announced published findings in the Proceedings of the National Academy of Sciences (PNAS),…
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NIH neuroscientists isolated promising mini antibodies against COVID-19 from a llama
On Dec. 22, 2020, the NIH researchers announced they had isolated a set of promising, tiny antibodies, or…
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NIH ACTIV Trial of blood thinners paused enrollment of critically ill COVID-19 patients
On Dec. 22, 2020, the NIH researchers announced that three clinical trial platforms working together to test the…
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Biotechnology | COVID-19 | FDA | Therapeutics
Sorrento announced it had submitted an EUA application to the FDA for COVI-STIX rapid test for detection of SARS-CoV-2 antigen
On Dec. 22, 2020, Sorrento Therapeutics announced that an Emergency Use Authorization (EUA) Application had been submitted to…
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Abivax’s Covid-19 phase 2b/3 miR-AGE trial with ABX464 declared National Priority by French government
On Dec. 22, 2020, Abivax announced that the Companyﾒs ongoing ABX464 phase 2b/3 trial in high-risk Covid-19 patients…
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COVID-19 targeted treatment trial launched in Vienna
On Dec. 22, 2020, a phase II clinical trial of a treatment for COVID-19 patients was started at…
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RedHill’s phase 2/3 COVID-19 study of opaganib passed second DSMB with unanimous recommendation
On Dec. 22, 2020, RedHill Biopharma announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva, ABC294640)1…
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CDC’s ACIP updated interim recommendation for allocation of COVID-19 vaccine
On Dec. 22, 2020, the ACIP updated interim vaccine allocation recommendations. In Phase 1b, COVID-19 vaccine should be…
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Cocrystal Pharma selected lead compound for further development against Coronaviruses
On Dec. 22, 2020, Cocrystal Pharma announced the selection of CDI-45205 as the lead compound for further development…
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Singapore approved sale of lab-grown meat in world first
On Dec. 1, 2020, the governmenrt of Singapore announced that it had given U.S. start-up Eat Just the…
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CVS Health began administering COVID-19 vaccines in long-term care facilities
On Dec. 21, 2020, CVS Health announced it had formally launched its COVID-19 vaccination program for long-term care…
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NIH announced support of radical approaches to nationwide COVID-19 testing and surveillance
On Dec. 21, 2020, the NIH announced that it had awarded over $107 million to support new, non-traditional…
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NIH funded eight studies to uncover risk factors for COVID-19-related inflammatory syndrome in children
On Dec. 21, 2020, the NIH announced that it had awarded eight research grants to develop approaches for…
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U.S. Dept. of Veterans Affairs began COVID-19 vaccinations at 128 additional sites
On Dec. 21, 2020, the U.S. Dept. of Veterans Affairs (VA) announced that it had begun COVID-19 vaccinations…
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European Commission approved Aimmune’s PALFORZIA as first-ever treatment for peanut allergy in the EU
On Dec. 21, 2020, Aimmune Therapeutics announced that the European Commission (EC) had approved PALFORZIA [defatted powder of…
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Quidel received Emergency Use Authorization for QuickVue SARS rapid antigen test for COVID-19 diagnosis
On Dec. 21, 2020, Quidel announced that it had received Emergency Use Authorization from the U.S. Food and…
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FDA granted IND approval for phase 2 clinical trial of Innovation Pharmasﾒ Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharma announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
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First patients, including a COVID-19 patient, treated with Abiomed’s ECMO technology
On Dec. 21, 2020, Abiomed announced the first two patients in the world had been treated with the…
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FDA granted IND approval for phase 2 clinical trial of Innovation Pharma’s Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharmaceuticals announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
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Labcorp made Pixel At-Home COVID-19 Collection Kit available through Walgreens Find Careﾮ
On Dec. 21, 2020, LabCorp and Walgreens announced that the Pixel by Labcorpﾙ At-Home COVID-19 Collection Kit is…
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Pfizer and BioNTech received CHMP positive opinion for their COVID-19 vaccine
On Dec. 21, 2020, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
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Pfizer and BioNTech received authorization in the European Union for COVID-19 vaccine
On Dec. 21, 2020, Pfizer and BioNTech announced that the European Commission (EC) had granted a conditional marketing…
