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Results For "Pharmaceuticals-and-Medical-Devices-Agency"

15 News Found

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients


Sai Life Sciences receive Certificate of Inspection from Japan PMDA
Biotech | December 02, 2021

Sai Life Sciences receive Certificate of Inspection from Japan PMDA

The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product


Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan
Biotech | November 18, 2021

Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan

It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan


Japan to purchase 150 million doses of Novavax’ Covid-19 vaccine from Takeda
Biotech | September 08, 2021

Japan to purchase 150 million doses of Novavax’ Covid-19 vaccine from Takeda

Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022