Business

Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen's COVID-19 vaccine candidate

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

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

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,

CureVac initiates Phase 2a clinical trial of COVID-19 vaccine candidate

CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), announced that the first participant has been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV.

New clinical trial for a COVID-19 vaccine authorised in Germany

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has authorised another Phase-1 clinical trial of a vaccine against COVID-19 in Germany. The new vaccine candidate is a so-called vector vaccine. Trials on vaccine candidates in humans are a significant step in the direction of authorising safe and efficacious vaccines against COVID-19.

Johnson & Johnson initiates pivotal global Phase 3 clinical trial of Janssen's COVID-19 vaccine candidate

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

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.

Business

More Pharma News ...