Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine
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- Category: Sanofi
Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.
Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility.
Russian application of Sputnik V vaccine for WHO vaccine prequalification among the first applications submitted
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The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world's first registered vaccine against the coronavirus Sputnik V, which is based on a well-studied platform of human adenoviral vectors. The Russian Federation has become one of the first countries to apply to WHO for prequalification of its vaccine against the novel coronavirus infection. Novavax provides Phase 3 COVID-19 vaccine clinical development update
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Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. Johnson & Johnson prepares to resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 vaccine candidate in the U.S.
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- Category: Johnson & Johnson
Johnson & Johnson is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.
The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway.
Moderna announces supply agreement with the Ministry of Public Health to supply Qatar with mRNA vaccine against COVID-19 (mRNA-1273)
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Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna's vaccine candidate against COVID-19, to support the Ministry's ongoing efforts to secure early access to a safe and effective COVID-19 vaccine for the people of Qatar. FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial
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- Category: AstraZeneca
Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.
The Food and Drug Administration (FDA) authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.
CureVac reports positive preclinical data for its COVID-19 vaccine candidate, CVnCoV
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CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced data from preclinical studies of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T cell activation. More Pharma News ...
- Moderna completes enrollment of Phase 3 COVE study of mRNA vaccine against COVID-19 (mRNA-1273)
- Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies
- Regeneron's REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients
- Gilead Sciences signs joint procurement agreement with the European Commission for Veklury® (remdesivir)
- COVID-19 Long-Acting AntiBody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials
- Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen's COVID-19 vaccine candidate
- Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19