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…
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…
Bausch Health’s DEXAVEN received new indication in Poland to treat patients with SARS-CoV-2
On Dec. 30, 2020, Bausch Health announced that the Office for Registration of Medicinal Products, Medical Devices and…
NIH study uncovered blood vessel damage and inflammation in COVID-19 patientsﾒ brains but no infection
On Dec. 30, 2020, the NIH researchers announced that an in-depth study of how COVID-19 affects a patientﾒs…
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…
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…
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…
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…
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…
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…
AIM ImmunoTech announced availability of ME/CFS clinical trial of drug Ampligen for enrollment to COVID-19 ﾑLong Haulersﾒ
On Dec. 24, 2020, AIM ImmunoTech announced that the post-COVID-19 ﾓLong Haulerﾔ portion of the active AMP-511 Expanded…
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…
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…
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…
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…
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…
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…
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…
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),…
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…
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…
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…
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…
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…
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…
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…
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…
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)…
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)…