Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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ORGANIZATION Backed by 12 Pharmas, US Nonprofit’s Cloud Platform Now Up and Running to Streamline Regulatory Submissions
March 26, 2024
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BUSINESS Eisai Settles Lenvima Patent Suit with Sun Pharma
March 26, 2024
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BUSINESS EMA Panel Gives Go-Ahead for Xtandi Use in Earlier Setting: Astellas
March 26, 2024
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BUSINESS Boehringer’s Brigimadlin Earns Sakigake Designation
March 26, 2024
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BUSINESS Daiichi Sankyo Files MMR Vaccine in Japan
March 26, 2024
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BUSINESS Hospitalized Cases Tied to Kobayashi Pharma’s Supplements Now Up to 26
March 26, 2024
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BUSINESS Lilly, Nippon Shinyaku Pair Up on Blood Cancer Med in Japan
March 26, 2024
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REGULATORY Japan’s 1st Eylea Biosimilar Approval on Horizon? JAN Now Decided
March 25, 2024
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BUSINESS Daiichi Sankyo Eyes 7 Additional Indications for Enhertu by 2026
March 25, 2024
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BUSINESS Ono Hooks Up with Oxford on Drug Discovery Research
March 25, 2024
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BUSINESS EMA Delays Decision on Leqembi Due to Procedural Issues
March 25, 2024
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BUSINESS Iclusig Gets Additional FDA Nod for Iclusig in Ph+ ALL: Takeda
March 25, 2024
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BUSINESS Novartis, Sandoz Recall Entacapone Products over Carcinogenic Risk
March 25, 2024
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BUSINESS Kobayashi Pharma Recalls Supplements on Reports of Kidney Disorders
March 25, 2024
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REGULATORY Chuikyo Agrees to Exempt PD-1/PD-L1, JAK Classes from Spillover Re-Pricing
March 25, 2024
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REGULATORY Xocova’s Price to Remain Intact after Full Approval, No Change in Clinical Positioning
March 25, 2024
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REGULATORY Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS
March 22, 2024
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REGULATORY Pharma Regulation Panel Wraps Up Debate, Report to Be Finalized Soon
March 22, 2024
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BUSINESS Japan, US CROs to Collaborate to Address Drug Lags/Losses
March 22, 2024
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BUSINESS Astellas Gives 1.5% Pay Raise to Acquire Best Talents
March 22, 2024
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Whenever an excellent employee or leader leaves, it’s a blow to your organization.The departure of staff is an inevitable part of business, but in a fiercely competitive recruitment landscape like Japan, employee retention is a priority.Not only does retaining staff…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…