Novavax announced positive preclinical data for combination influenza and COVID-19 vaccine candidate
On May 10, 2021, Novavax announced data from a preclinical study of the company’s combination quadrivalent seasonal flu…
FDA granted Fast Track Designation to CERC-002 for treatment of hospitalized patients with COVID-19
On May 10, 2021, Cerecor announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…
Pfizer and BioNTech received first U.S. EUA of COVID-19 vaccine in adolescents
On May 10, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
INOVIO announced positive data from phase 2 clinical trial evaluating INO-4800 COVID-19 DNA vaccine
On May 10, 2021, Inovio Pharma announced positive safety, tolerability and immunogenicity data from its placebo-controlled and blinded…
WHO listed additional COVID-19 vaccine for emergency use and issues interim policy recommendations
On May 7, 2021, the World Health Organization (WHO) listed the Sinopharm COVID-19 vaccine for emergency use, giving…
Pfizer and BioNTech initiated rolling submission of Biologics License Application for FDA approval of COVID-19 vaccine
On May 7, 2021, Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the…
GSK and Vir Biotechnology announced start of the EMA rolling review of VIR-7831 (sotrovimab) for early treatment of COVID-19
On May 7, 2021, GlaxoSmithKline and Vir Biotechnology announced that the European Medicines Agency (EMA) has started a…
Moderna announced agreement with Switzerland for 7 million booster vaccine doses in 2022 with options
On May 6, 2021, Moderna announced a new supply agreement with the Swiss Federal Government for 7 million…
Novavax and Gavi executed advance purchase agreement for COVID-19 vaccine for COVAX facility
On May 6, 2021, Novavax announced that it had finalized an advance purchase agreement (APA) with Gavi, the…
Pfizer and BioNTech announced supplying COVID-19 vaccine for Olympic athletes at 2020 Tokyo games
On May 6, 2021, Pfizer announced the signing of a Memorandum of Understanding (MoU) with the International Olympic…
Trevena announced TRV027 selected by NIH-funded ACTIV initiative for COVID-19 trial
On May 6, 2021, Trevena announced that TRV027, the Companyﾒs novel AT1 receptor selective agonist, had been selected…
U.S. sent first flight of medical supplies to India for COVID-19 fight
On May 5, 2021, the United States sent its first flight loaded with oxygen cylinders and regulators, N95…
Humanigen reported positive phase 3 results demonstrating Lenzilumabﾙ improved survival without mechanical ventilation with COVID-19
On May 5, 2021, Humanigen announced that results from the lenzilumab Phase 3 study in hospitalized COVID-19 patients…
NEJM published phase 2b clinical trial results demonstrating efficacy of COVID-19 vaccine against B.1.351 variant
On May 5, 2021, Novavax announced the publication of results from the initial primary analysis of a Phase…
Pfizer and BioNTech received Health Canada authorization of COVID-19 vaccine in adolescents
On May 5, 2021, Pfizer and BioNTech announced that Health Canada had expanded the Interim Order authorization for…
Hoth Therapeutics and Virginia Commonwealth University expanded research agreement for COVID-19 therapeutic
On May 5, 2021, Hoth Therapeutics announced it has expanded its sponsored research agreement with Virginia Commonwealth University…
CytoDyn reaches agreement with Albert Einstein Israelite Hospital in Brazil to conduct two COVID-19 trials
On May 5, 2021, CytoDyn announced an agreement to partner with the Albert Einstein Israelite Hospital (AEIH) in…
HDT Bio, Gennova Biopharma announced volunteers dosed in phase I/II trials of COVID-19 RNA vaccine in India
On May 4, 2021, HDT Bio announced that its development partner in India, Gennova Biopharmaceuticals, had begun dosing…
WHO welcomed Sweden’s announcement to share COVID-19 vaccine doses with COVAX
On May 3, 2021, the World Health Organization (WHO) welcomed the Government of Swedenﾒs announcement to share 1…
Eiger announced Peginterferon Lambda added to multi-center phase 3 TOGETHER COVID-19 study in Brazil
On May 3, 2021, Eiger BioPharmaceuticals announced announced that Peginterferon Lambda (Lambda) will be added to the ongoing,…
Data from Vaxart oral COVID-19 vaccine phase I study suggested broad cross-reactivity against Coronaviruses
On May 3, 2021, Vaxart announced that new data obtained from its Phase I COVID-19 trial added to…
Biotechnology | COVID-19 | Diagnostics | FDA
Precipio launched Rapid COVID-19 Antibody test on Amazon platform
On May 3, 2021, Precipio announced that it had successfully launched its COVID-19 rapid antibody test (20 minute)…
Moderna announced supply agreement with Gavi for up to 500 million doses of COVID-19 Vaccine Moderna for COVAX
On May 3, 2021, Moderna announced an agreement with Gavi, the Vaccine Alliance to supply up to 500…
Novavax initiated pediatric expansion for phase 3 clinical trial of COVID-19 vaccine
On May 3, 2021, Novavax announced that it had initiated a pediatric expansion of its Phase 3 clinical…
Gavi signed agreement with Moderna to secure doses on behalf of COVAX Facility
On May 3, 2021, Gavi, the Vaccine Alliance, that it had signed an advance purchase agreement with Moderna…
Moderna announced Emergency Use listing granted by the WHO for its COVID-19 vaccine
On Apr. 30, 2021, Moderna announced that the World Health Organization (WHO) had issued Emergency Use Listing (EUL)…
Lonza and Moderna entered agreement to double drug substance production for COVID-19 vaccine in Visp
On Apr. 29, 2021, Lonza announced the expansion of its collaboration with Moderna to manufacture the drug substance…
NIH announced investment of $29 million to address COVID-19 disparities
On Apr. 29, 2021, the National Institutes of Health announced it was funding $29 million in additional grants…
Large collaboration created cell atlas of COVID-19 pathology
On Apr. 29, 2021, scientists from several hospitals and research centers reported what happens in individual cells of…
Moderna announced an increased global supply for COVID-19 vaccine to up to 3 billion doses in 2022
On Apr. 29, 2021, Moderna announced it was making new funding commitments to increase supply at its owned…