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Results For "Japan"

352 News Found

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


AGC and Medinet sign agreement for cell therapy CDMO business
News | September 12, 2024

AGC and Medinet sign agreement for cell therapy CDMO business

A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan


Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9
Clinical Trials | September 11, 2024

Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9


Briefs: Ami Organics and Dr. Reddy’s Laboratories
Drug Approval | September 09, 2024

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.


Roche’s PiaSky approved in the EU for treatment of people with PNH
Drug Approval | September 03, 2024

Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Mitsubishi Chemical's clinical study demonstrates effectiveness of probiotic on intestinal environment
News | September 01, 2024

Mitsubishi Chemical's clinical study demonstrates effectiveness of probiotic on intestinal environment

H.coagulans is, unlike other general lactobacillus, characterized by spore formation, giving it resistance to acid and heat


Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Fasenra approved in China for the treatment of severe eosinophilic asthma
Drug Approval | August 25, 2024

Fasenra approved in China for the treatment of severe eosinophilic asthma

Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile