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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Reston Ebolavirus spreads efficiently in pigs
On Dec. 21, 2020, the U.S. National Institutes of Health (NIH) announced a study published in the Proceedings…
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…
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…
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…
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…
CDC’s ACIP announced interim recommendation for use of Moderna COVID-19 Vaccine
On Dec. 19, 2020, after a transparent, evidence-based review of available data, the Advisory Committee on Immunization Practices…
Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY
On Dec. 19, 2020, Pfizer and BioNTech announced they supplying an additional 100 million doses of COMIRNATY the…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved first adjuvant therapy for most common type of lung cancer
On Dec. 18, 2020, the the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) as the…
National Research Council of Canada supported development of 4 COVID-19 therapeutic candidates
On Dec. 18, 2020, the National Research Council of Canada (NRC) announced it was providing advisory services and…
FDA issued Emergency Use Authorization for second COVID-19 vaccine
On Dec. 18, 2020, the FDA issued an emergency use authorization (EUA) for the second vaccine for the…
Lilly began pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico
On Dec. 18, 2020, Eli Lilly announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in…
EC exercised option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate
On Dec. 18, 2020, Moderna announced that the European Commission (EC) had exercised its option to purchase an…
Moderna announced FDA authorization of Moderna COVID-19 vaccine in U.S.
On Dec. 18, 2020, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
CDC Advisory Committee on Immunization Practices recommended vaccination with Moderna’s COVID-19 vaccine
On Dec. 18, 2020, Moderna announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on…