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.
Sanofi and GSK will provide up to 300 million doses of COVID-19 vaccine to the European Union
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- Category: Sanofi
Sanofi and GSK finalized and signed today an Advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. The vaccine candidate is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established adjuvant technology.
Lilly and Amgen announce manufacturing collaboration for COVID-19 antibody therapies
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- Category: Amgen
Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination.
Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.
More Pharma News ...
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- Sinovac reports preliminary Phase I/II results of COVID-19 vaccine in elderly volunteers
- Pfizer and BioNTech announce data from preclinical studies of mRNA-based vaccine candidate against COVID-19
- Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause
- Biopharma leaders unite to stand with science
- Johnson & Johnson announces that Janssen's COVID-19 investigational vaccine candidate prevents severe clinical disease in pre-clinical studies