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Biogen Files New Drug Application for Aducanumab in Japan

Today, Biogen and Eisai, Co., Ltd. announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and ...
Dec 10

Astellas receives approval of EVRENZO in Japan for the treatment of anemia of chronic kidney disease

This approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis...
Nov 27

Novartis expands Kymriah manufacturing footprint in Asia

first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia...
Oct 31

Takeda collaborates with Moderna to supply COVID-19 vaccine in Japan

Takeda expands COVID-19 vaccine supply in Japan through partnership with Moderna and Government of Japan ...
Oct 29

HUYA Bioscience announces orphan drug Designation for HBI-8000 in Japan

HBI-8000 for Monotherapy Adult T-cell Leukemia-Lymphoma ATL ...
Oct 01

Novavax and Takeda Announce collaboration for Novavax’ COVID-19 vaccine candidate in Japan

Novavax partners with Takeda for manufacturing and marketing covid vaccine in Japan...
Aug 08

Pfizer & BioNTech will supply Japan with 120 M doses of their vaccine

...
Aug 01

Teijin receives marketing approval for Merz’s Xeomin, Botulinum toxin

Marketing approval for Merz’s Xeomin Botulinum toxin Type A in Japan...
Jun 29

Sun Pharma announces Japan MHLW approval of ILUMYA

ILUMYA is one of the key specialty products of Sun Pharma...
Jun 29

Gilead Sciences collaborates with Indian Companies for Remdesivir

Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead Sciences manufacturing process for remdesivir to enable them ...
May 13

New Data at ESMO 2019 for Merck Highlight Focused Clinical Development and Commitment to Patient Care

New subgroup analyses for first-line treatment of advanced renal cell carcinoma with BAVENCIO®* (avelumab) in combination with axitinib...
Sep 23

Updated Results for Investigational Therapy Tepotinib Presented at WCLC 2019

Results include progression-free survival and overall survival data from Phase Ib/II INSIGHT study Phase II INSIGHT 2 study now open for enrollment for ...
Sep 12

Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations

Investigational oral MET inhibitor has previously received SAKIGAKE 'fast-track' regulatory designation in Japan - MET exon 14 skipping alterations and MET amplifications are present in ...
Sep 11

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