Japan became first country to approve Regeneron antibody cocktail (casirivimab and imdevimab) for treatment of COVID-19
On Jul. 20, 2021, Regeneron announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) had approved Regeneron’s…
Biotechnology | COVID-19 | FDA
U.S. FDA granted Priority Review for Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
On Jul. 16, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had granted…
Corvus discontinued phase 3 study of mupadolimab for COVID-19 due to vaccine effectiveness in reducing hospitalizations
On Jul. 15, 2021, Corvus Pharmaceuticals announced that it had discontinued its Phase 3 study of mupadolimab for…
iBio reported successful preclinical immunization studies with next-gen nucleocapsid COVID-19 vaccine
On Jul. 15, 2021, iBio announced that preclinical studies of IBIO-202, its subunit vaccine candidate that targets the…
Hologic obtained European CE Mark for use of saliva samples with COVID-19 test
On Jul. 14, 2021, Hologic announced that it had obtained a CE Mark for the use of saliva…
Relief Therapeutics reported that partner, NRx Pharma, and Quantum Leap announced treatment of severely ill COVID-19 patients
On Jul. 13, 2021, RELIEF THERAPEUTICS reported that its collaboration partner, NRx Pharmaceuticals, and Quantum Leap Healthcare Collaborativeﾙ…
U.S. FDA announced revisions JNJ COVID-19 Vaccine fact sheets to include information pertaining to Guillain-Barre Syndrome
On Jul. 13, 2021, the Food and Drug Administration (FDA) revisions to the vaccine recipient and vaccination provider…
Moderna announced supply agreement with Argentina for 20 million doses of its COVID-19 vaccine
On Jul. 12, 2021, Moderna announced a supply agreement with the government of Argentina for 20 million doses…
10 million doses of mRNA-based COVID-19 vaccine supplied to Taiwan Region
On Jul. 12, 2021, BioNTech announced that Fosun Industrial Co. had reached advance procurement agreements for the mRNA-based…
Gavi signed agreements with Sinopharm and Sinovac for immediate supply to COVAX
On Jul. 12, 2021, Gavi, the Vaccine Alliance, announced that it had signed advance purchase agreements with Sinopharm…
UKﾒs MHRA accepted Humanigenﾒs submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
On Jul. 9, 2021, Humanigen announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in Jun….
NIH study associated COVID-19 surged with mortality increases for patients
On Jul. 8, 2021, the National Institutes of Health (NIH) announced that a new study authored by scientists…
Rice, Rutgers announced development of inhalable COVID-19 vaccine spray
On Jul. 7, 2021, Rice University announced a study to develop an inhalable COVID-19 vaccine. The project led…
WHO recommended interleukin-6 receptor blockers for COVID-19 and urged producers to join efforts to rapidly increase access
On Jul. 6, 2021, the World Health Organization announced updated patient care guidelines to include interleukin-6 receptor blockers,…
Dynavax and Biological E announced agreement of Dynavax’s CpG 1018 adjuvant for Biological E’s COVID-19 vaccine candidate
On Jul. 6, 2021, Dynavax Technologies and Biological E announced the execution of a commercial supply agreement of…
U.S. FDA authorized an EUA for the Janssen COVID-19 vaccine manufacture at Emergent facility
On Jul. 2, 2021, the Food and Drug Administration (FDA) authorized the use, under the emergency use authorization…
Moderna announced Recipharm site in France manufacturing COVID-19 Vaccine following approval by EMA
On Jul. 1, 2021, Moderna confirmed that following the European Medicines Agency’s (EMA) Committee for Human Medicines (CHMP)…
HDT Bio received notice to proceed from FDA for U.S. phase 1 clinical trial of RNA COVID-19 vaccine
On Jul. 1, 2021, HDT Bio announced the U.S. Food and Drug Administration had reviewed the companyﾒs Investigational…
Ateaﾒs AT-527 oral antiviral drug candidate reduced viral replication in hospitalized patients with COVID-19
On Jun. 30, 2021, Atea Pharmaceuticals announced positive interim results from the global Phase 2 study evaluating AT-527…
Biotechnology | COVID-19 | Diagnostics | NIH
NIH-funded screening study builds case for frequent COVID-19 antigen testing
On Jun. 30, 2021, the National Institutes of Health announced a highly anticipated study that compared rapid antigen…
CureVac announced final data from phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV
On Jun. 30, 2021, CureVac announced results from the final analysis of its 40,000 subject international pivotal Phase…
XPhyto supplied 10 test centers in Berlin with 25-minute COVID-19 PCR test
On Jun. 30, 2021, XPhyto announced that it had signed a master supply agreement with Beovita and Tackleberries,…
Novavax published results of UK phase 3 clinical trial demonstrating high levels of COVID-19 vaccine efficacy
On Jun. 30, 2021, Novavax announced the publication of results from the final analysis of a pivotal Phase…
Gavi signed agreement with Clover Biopharmaceuticals for supply to COVAX
On Jun. 30, 2021, Gavi, the Vaccine Alliance, that it had signed an advance purchase agreement with Clover…
Fostamatinib selected for NIH ACTIV-4 COVID-19 clinical trial
On Jun. 29, 2021, Rigel Pharma announced that fostamatinib, the Company’s novel oral spleen tyrosine kinase (SYK) inhibitor,…
Adjuvant developed with NIH funding enhanced efficacy of Indiaﾒs COVID-19 vaccine
On Jun. 29, 2021, the National Institutes of Health announced that an adjuvant developed with its funding had…
Moderna provides a clinical update on neutralizing activity of COVID-19 vaccine on emerging variants
On Jun. 29, 2021, Moderna announced new results from in vitro neutralization studies of sera from individuals vaccinated…
Moderna announces Emergency Use Authorization for its COVID-19 vaccine granted by Government of India
On Jun. 29, 2021, Moderna announced that the government of India had issued a registration certificate and a…
VBI Vaccines announced initial positive phase 1 data for its eVLP vaccine candidate against COVID-19
On Jun. 29, 2021, VBI Vaccines announced positive Phase 1 data from its Phase 1/2 trial of the…
First trial participants vaccinated with Oxford COVID-19 variant vaccine
On Jun. 28, 2021, the University of Oxford in partnership with AstraZeneca began vaccinations for a new phase…