Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate
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- Category: GlaxoSmithKline
Today, Sanofi and GlaxoSmithKline plc (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global randomized, double-blind, placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa and Latin America.
Pfizer and BioNTech to supply the European Union with up to 1.8 billion additional doses of COMIRNATY®
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses.
European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan
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- Category: AstraZeneca
AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and older, to prevent COVID-19 caused by SARS-CoV-2.
Takeda announces approval of Moderna's COVID-19 vaccine in Japan
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- Category: Takeda
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna's mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan.
Novartis reaches milestone delivery of 1 billion courses of antimalarial treatment
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- Category: Novartis
Novartis announced that it has delivered one billion courses of antimalarial treatment since 1999. More than 90% of this artemisinin-based combination therapy (ACT) was supplied without profit to malaria-endemic countries around the globe.
Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial
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- Category: Sanofi
The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks.
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- Moderna announces emergency use listing granted by the World Health Organization for its COVID-19 vaccine