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…
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…
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…
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the FDA approved the first generic of glucagon for injection USP, 1 mg/vial packaged…
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…
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…
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…
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…
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…
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…
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…
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…
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 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…
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…
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…
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…
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…
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…
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…