Peer-reviewed report on Moderna COVID-19 vaccine published
On Dec. 30, 2020, the National Institutes of Health (NIH) announced that the investigational vaccine known as mRNA-1273…
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Biotechnology | COVID-19 | FDA | NIH | Therapeutics
Medigen Vaccines obtained TFDA phase 2 IND approval for COVID19 vaccine
On Dec. 30, 2020, Medigen Vaccine Biologics announced that it had obtained TFDA Phase 2 IND approval of…
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UK medicines regulator approved Oxford University/AstraZeneca COVID-19 vaccine
On Dec. 30, 2020, the COVID-19 vaccine developed by Oxford University/AstraZeneca was given regulatory approval by the UK…
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Mateon global study for OT-101/ TGF-inhibitor against COVID-19 treated its first patient
On Dec. 30, 2020, Mateon Therapeutics announced that it had enrolled and treated its first sentinel Part 1…
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Recipharm and Moderna finalized agreement for aseptic drug manufacturing and fill-finish for countries outside the U.S.
On Dec. 30, 2020, Moderna announced that they had reached an agreement to support formulation and fill-finish a…
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Regeneron announced encouraging data from COVID-19 antibody cocktail trial in hospitalized patient
On Dec. 29, 2020, Regeneron announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the…
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Emergent and Mount Sinai Health System announced clinical program to evuate COVID-HIG product candidate
On Dec. 29, 2020, Emergent BioSolutions and Mount Sinai Health System announced initiation of the clinical program to…
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Moderna confirmed discussions with government of South Korea to supply 40 million doses of COVID-19 vaccine
On Dec. 29, 2020, Moderna confirmed that the Company was engaged in discussions with the government of South…
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UNMC participated in COVID-19 vaccine study, planned to enroll 1,000
On Dec. 29, 2020, University of Nebraska Medical Center (UNMC) and Nebraska Medicine announced participation in a clinical…
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Novavax initiated PREVENT-19 pivotal phase 3 efficacy trial of COVID-19 vaccine in the U.S. and Mexico
On Dec. 28, 2020, Novavax announced initiation of PREVENT-19, its pivotal Phase 3 study in the U.S. and…
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Soligenix announced $15 million NIH SBIR award advancing COVID-19 vaccine development
On Dec. 28, 2020, Soligenix announced that the National Institute of Allergy and Infectious Diseases (NIAID), had awarded…
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AIM ImmunoTech announced availability of ME/CFS clinical trial of drug Ampligen for enrollment to COVID-19 ‘Long Haulers’
On Dec. 24, 2020, AIM ImmunoTech announced that the post-COVID-19 ‘Long Hauler’ portion of the active AMP-511 Expanded…
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INOVIO announced publication of phase 1 data from COVID-19 DNA vaccine candidate in The Lancet
On Dec. 24, 2020, Inovio Pharmaceuticals announced publication of peer-reviewed Phase 1 clinical data from the first cohort…
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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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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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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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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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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 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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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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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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Biotechnology | COVID-19 | Diagnostics | Genomics | Vaccine | WHO
New SARS-CoV-2 variant identified through viral genomic sequencing in United Kingdom and Northern Ireland
On Dec. 21, 2020, the WHO reported that authorities of the United Kingdom of Great Britain and Northern…
