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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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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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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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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Additional DOD locations selected to support COVID-19 vaccine clinical trials
On Dec. 29, 2020, the U.S. Department of Defense (DOD) announced that the Womack Army Medical Center was…
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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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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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Biotechnology | Disease | FDA | Therapeutics
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the U.S. Food and Drug Administration approved the first generic of glucagon for injection…
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The Serum Institute of India launched India’s first indigenously developed pneumococcal vaccine
On Dec. 28, 2020, Serum Institute of India announced the launch of India’s first indigenously developed pneumococcal vaccine…
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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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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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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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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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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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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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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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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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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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Merck announced agreement with US Government for doses of Investigational biological therapy for COVID-19 patients
On Dec. 23, 2020, Merck announced an agreement with the U.S. Government to support the development, manufacture and…
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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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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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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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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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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 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…
