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Results For "PMDA"

30 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


Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension
Drug Approval | August 24, 2022

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA


Piramal Pharma expands API capabilities at Digwal
News | June 15, 2022

Piramal Pharma expands API capabilities at Digwal

Site has a capital investment program of ~$30 million spent or committed over the last three years to expand capabilities and improve operational efficiencies


Piramal Pharma Solutions new API plant in Canada goes online
Biotech | May 19, 2022

Piramal Pharma Solutions new API plant in Canada goes online

It is part of the company's CAD $30 million capital investment in the Aurora, Canada site


WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


Industry seeks favourable policy for India to move up the pharma value chain globally
Policy | February 27, 2022

Industry seeks favourable policy for India to move up the pharma value chain globally

N Yuvraj, Joint Secretary, Dept of Pharmaceuticals, Satish Reddy, Chairman, Dr Reddy’s Laboratories; Kiran Mazumdar Shaw, Executive Chairperson, Biocon Group; Sanjiv Navangul, MD & CEO, Bharat Serums and Vaccines and Shravil Patel, MD, Zydus Lifesciences discuss the way forward for the India pharma industry


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