G20 leaders boosted support of the Access to COVID-19 Tools Accelerator
On May 21, 2021, world leaders the Global Health Summit adopted an agenda to overcome the COVID-19 pandemic,…
Japanﾒs Ministry of Health, Labour and Welfare approved Modernaﾒs COVID-19 vaccine
On May 21, 2021, Moderna announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan granted…
Ministry of Food and Drug Safety of South Korea authorized Modernaﾒs COVID-19 vaccine
On May 21, 2021, Moderna announced that the Ministry of Food and Drug Safety of South Korea (MFDS)…
Complete trial results manuscript of Novavax COVID-19 investigational vaccine posted to preprint server medRxiv
On May 21, 2021, Novavax announced that the full results from the Phase 3, randomized, observer-blinded, placebo-controlled trial…
Novavax announced participation in mix-and-match COVID-19 vaccine booster trial in the United Kingdom
On May 21, 2021, Novavax announced participation in a mix-and-match (vaccine interchangeability) COVID-19 vaccine booster trial that led…
Gavi signed agreement with Johnson & Johnson for supply of its COVID-19 vaccine to COVAX
On May 21, 2021, Gavi, the Vaccine Alliance, that it had signed an advance purchase agreement with Johnson…
XPhyto rapid point-of-care COVID-19 PCR test offered for sale in Germany
On May 20, 2021, XPhyto announced that its distribution, storage and logistics partner, Max Pharm has begun the…
Brazilian HRA authorized Sorrento phase 2 pivotal clinical trial of COVI-MSCﾙ in hospitalized COVID-19 patients with ARDS
On May 20, 2021, Sorrento Therapeutics announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed…
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Pfizer and BioNTech announced supplying EU with up to 1.8 billion additional doses of COMIRNATY
On May 20, 2021, Pfizer and BioNTech announced a new agreement with the European Commission (EC) to supply…
Pfizer and BioNTech signed agreement to supply 60 million additional doses of their COVID-19 vaccine to Turkey
On May 20, 2021, Pfizer and BioNTech announced an agreement with Turkeyﾒs Ministry of Health to supply 60…
APEIRON Biologics’ APN01 selected for large-scale U.S. trial in COVID-19
On May 19, 2021, APEIRON Biologics announced the next development steps for APN01 (alunacedase alfa) for the treatment…
Medicago and GSK announced positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate
On May 18, 2021, GlaxoSmithKline and Medicago reported positive interim Phase 2 clinical trial safety and immunogenicity data…
Oxford University and Oracle partnered to speed identification of COVID-19 variants
On May 17, 2021, Oxford University and Oracle announced they had created a Global Pathogen Analysis System combining…
Sanofi and GSK COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in Phase 2 trial
On May 17, 2021, Sanofi and GSK reported that their adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates…
Second-generation COVID-19 vaccine candidate, CV2CoV, demonstrated high immunogenicity in preclinical study
On May 13, 2021, CureVac announced together with its collaboration partner GSK, first preclinical data in a rat…
Moderna announced new supply agreement with Australia for 25 million doses of its COVID-19 vaccine
On May 12, 2021, Moderna announced a new supply agreement with the government of Australia for 25 million…
INOVIO’s Pan-COVID-19 vaccine candidate (INO-4802) induces broad immunity against vviral variants in preclinical studies
On May 12, 2021, Inovio Pharma announced that its next-generation Pan-COVID-19 vaccine candidate, INO-4802, induced potent neutralizing antibodies…
InBios received FDA EUA for COVID-19 POC antigen detection test
On May 12, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
InBios received FDA EUA for COVID-19 POC antigen detection test
On May 12, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
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…
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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…
COVID-19 | FDA | Life Science News | Vaccine
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…