Australia Therapeutic Goods Administration granted provisional registration for Novavax COVID-19 vaccine
On Jan. 19, 2022, Novavaxa announced that Australia’s Therapeutic Goods Administration had granted approval for provisional registration of…
Brazilian Health Regulatory Agency authorized Sorrento phase 2 clinical trial of COVI-MSC in COVID-19l long-hauler patients
On Jan. 18, 2022, Sorrento Therapeutics announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed…
Merck and Ridgeback announced supply agreement with UNICEF for molnupiravir, investigational oral antiviral COVID-19 medicine
On Jan. 18, 2022, Merck and Ridgeback Biotherapeutics announced the signing of a long-term supply agreement with the…
COVAX delivered its 1 billionth COVID-19 vaccine dose
On Jan. 16, 2022, the WHO announced that it had shipped 1.1 million COVID-19 vaccines to Rwanda on…
WHO recommended two new drugs to treat patients with COVID-19
On Jan. 14, 2022, the WHO announced that it had recommended two new drugs for COVID-19, providing yet…
U.S. FDA authorizd InteliSwabﾙ COVID-19 rapid tests for at-home testing for delta variant detection
On Jan. 13, 2022, OraSure Technologies that its InteliSwabﾮ COVID-19 rapid tests detected the Omicron variant as effectively…
DoD awarded contracts to purchase COVID-19 antigen OTC test kits in support of POTUS’ 500 million free at-home COVID-19 Tests
On Jan. 14, 2022, the U.S. Department of Defense, in coordination with the U.S. Department of Health and…
South Korea Ministry of Food and Drug Safety approved Novavax COVID-19 vaccine
On Jan. 12, 2022, Novavax and SK bioscience, a vaccine business subsidiary of Korea-based SK Group, announced that…
Positive results of Pfizer’s phase 3 study exploring co-administration of PREVNAR 20 with Pfizer-BioNTech COVID-19 vaccine released
On Jan. 12, 2022, Pfizer announced positive top-line results from a Phase 3 study describing the safety and…
BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants
On Jan. 11, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
GSK and Vir Biotech announced U.S. government purchase of sotrovimab for treatment of COVID-19
On Jan. 11, 2022, GlaxoSmithKline and Vir Biotechnology announced the US Government had purchased an additional 600,000 doses…
Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19
On Jan. 10, 2022, Novartis Molecular Partners announced that Part A of the EMPATHY clinical trial that compared…
Novavax and Serum Institute filed for Emergency Use Authorization of Novavax’ COVID-19 vaccine in South Africa
On Jan. 10, 2022, Novavax and Serum Institute of India announced a regulatory submission to the South African…
Biden-Harris administration required insurance and group health plans to cover cost of at-home COVID-19 tests
On Jan. 10, 2022, the Biden-Harris Administration announced it was requiring insurance companies and group health plans to…
DoD awarded contract to Revival Health to purchase COVID-19 Antigen OTC kits in support of POTUS’ 500 million free at-home COVID-19 rests
On Jan. 7, 2022, the Department of Defense, in coordination with the U.S. Department of Health and Human…
Humanigen announced target enrollment in phase 2/3 ACTIV-5/BET-B trial of Lenzilumab for treatment of COVID-19 was met
On Jan. 5, 2021, Humanigen announced that target enrollment in the Phase 2/3 ACTIV-5/BET-B study had been achieved….
Pfizer and BioNTech signed global collaboration agreement to develop first mRNA-based shingles vaccine
On Jan. 5, 2022, Pfizer and BioNTech announced a new research, development and commercialization collaboration to develop a…
COVID-19 | FDA | Life Science History | NIH
NRx Pharmac submited EUA Application to US FDA for ZYESAMIﾮ (aviptadil) to treat patients at risk of death from COVID-19
On Jan 5, 2022, NRx Pharmaceuticals announced that it had submitted an application for Emergency Use Authorization (EUA)…
Pfizer provided U.S. Government with additional 10 million treatment courses of oral therapy to help combat COVID-19
On Jan. 4, 2022, Pfizer announced that the U.S. government had committed to purchasing an additional 10 million…
Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older
On Jan. 3, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
Amyris and Immunitybio completed joint venture for next generation Covid-19 RNA vaccine
On Jan. 3, 2022, Amyris and ImmunityBio announced the completion of a previously announced joint venture agreement to…
Lenzilumab treatment response in hospitalized COVID-19 patients correlated with C-Reactive protein levels
On Jan. 3, 2021, Humanigen announced that a manuscript detailing the results of an analysis of CRP levels…
Johnson & Johnson COVID-19 vaccine demonstrated 85 percent effectiveness against hospitalization in South Africa when Omicron was dominant
On Dec. 30, 2021, Johnson & Johnson announced preliminary results from the South African Phase 3b Sisonke study…
NRx Pharma filed Breakthrough Therapy Designation request for ZYESAMIﾮ (aviptadil) in patients at risk of COVID-19 death
On Dec. 29, 2021, NRx Pharmaceuticals announced that it hds filed a new Breakthrough Therapy Designation (BTD) request…
U.S. DoD awarded $136.7 million to MilliporeSigma for domestic production capacity of COVID-19 point-of-care tests parts
On Dec. 29, 2021, the Department of Defense (DoD), on behalf of and in coordination with the U.S….
Novavax and Serum Institute of India received Emergency Use Authorization for COVID-19 vaccine in India
On Dec. 28, 2021, Novavax and Serum Institute of India announced that the Drugs Controller General of India…
COVID-19 vaccine developed by Biological E using Dynavax’s CpG 1018 adjuvant received India DCGI approval for emergency use
On Dec. 28, 2021, Dynavax announced that Biological E had reported that CORBEVAXﾙ, their COVID-19 vaccine which contains…
Biotechnology | COVID-19 | Disease | Genomics
PacBio’s HiFiViral Surveillance Kit Performance not impacted by Omicron mutations
On Dec. 28, 2021, Pacific Biosciences announced that its new HiFiViral SARS-CoV-2 solution had successfully sequenced and captured…
Development of WRAI’s pan-coronavirus vaccine showed promise
On Dec. 28, 2021, researchers at the Walter Reed Army Institute of Research in Silver Spring, Maryland announced…
Moderna announced Switzerland exercised option to purchase seven million additional doses of COVID-19 booster vaccine
On Dec. 27, 2021, Moderna announced that the Swiss Federal Government had exercised its option to purchase an…