COVID-19 Long-Acting AntiBody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials
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- Category: AstraZeneca
AstraZeneca's long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US that are due to begin in the next weeks. The LAABs have been engineered with AstraZeneca's proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration.
Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen's COVID-19 vaccine candidate
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- Category: Johnson & Johnson
Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators.
Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19
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- Category: GlaxoSmithKline
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalisation.
BioNTech and Pfizer initiate rolling submission to European Medicines Agency for SARS-CoV-2 vaccine candidate BNT162b2
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies' vaccine development program against COVID-19. The EMA's decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults,
COVID-19 vaccine AZD1222 clinical trial resumed in Japan, follows restart of trials in the UK, Brazil, South Africa and India
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- Category: AstraZeneca
The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
A standard review process triggered a voluntary pause to vaccination across all global trials on 6 September to allow review of safety data by an independent committee.
Johnson & Johnson initiates pivotal global Phase 3 clinical trial of Janssen's COVID-19 vaccine candidate
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- Category: Johnson & Johnson
Johnson & Johnson (NYSE: JNJ) (the Company) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company's Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.
Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine
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- Category: GlaxoSmithKline
Sanofi and GSK have signed agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said: "Today's announcement showcases our unwavering commitment to develop a COVID-19 vaccine that is available to everyone when it comes to market.
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- Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial
- COVID-19 vaccine AZD1222 clinical trials resumed in the UK
- CureVac expected to receive up to 252 million euros from the German Federal Ministry of Research for further COVID-19 vaccine development and production capacity expansion
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