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Takeda Announces Approval of Nuvaxovid® COVID-19 Vaccine for Primary and Booster Immunization in Japan - Press Release

− Nuvaxovid Intramuscular Injection, containing Matrix-MTM adjuvant, is the first recombinant protein-based COVID-19 vaccine approved for use in Japan ....

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Takeda Pharmaceutical : Submits New Drug Application for Novavax' COVID-19 Vaccine Candidate in Japan

News Release

Takeda Submits New Drug Application for Novavax COVID-19 Vaccine Candidate

in Japan

. | December 16, 2021 ....

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Syngene International appoints Kush Parmar as an Additional Director

Syngene International appoints Kush Parmar as an Additional Director
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Takeda Announces Approval of Moderna's COVID-19 Vaccine in Japan

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Takeda Announces Approval of Moderna’s COVID-19 Vaccine in Japan
- The Ministry of Health, Labour and Welfare (MHLW) Grants Regulatory Approval of Moderna’s COVID-19 Vaccine (COVID-19 Vaccine Moderna Intramuscular Injection) Following Positive Interim Results in Takeda’s Phase 1/2 Immunogenicity and Safety Clinical Trial
- Interim Results Indicate Immune Response Consistent with Moderna’s Pivotal Phase 3 COVE Trial Results
- Takeda Will Immediately Begin Distribution in Japan
OSAKA, Japan, May 21, 2021 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. The approval is based on positive clinical da ....

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Quantum Leap Healthcare Collaborative Concludes Cenicriviroc Not Likely to Reduce Time to Recovery or Mortality in Critically Ill Patients in I-SPY COVID Trial

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SAN FRANCISCO, April 28, 2021 /PRNewswire/ Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, today announced that cenicriviroc (CVC) has been dropped from the trial due to futility, based on the low likelihood of success. CVC was chosen for testing because it is a CCR2/5 inhibitor, which has been hypothesized to potentially prevent fibrosis linked to the inflammation that accompanies critical illness associated with COVID-19.
The I-SPY COVID Trial is a phase II, open label, adaptive platform trial being conducted in critically ill COVID-19 patients who are receiving high-flow oxygen or mechanical ventilation. The trial was designed to rapidly screen agents to find those with the best chance of reducing time to recovery (defined as reduction in oxygen demand) by approximately 50% and reducing risk of death. The I-SPY COVID Trial identified the initial agents for the study through a unique partner ....

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