Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
BUSINESS
Daiichi Sankyo’s TROP2 ADC Now under US FDA Review for Lung Cancer
Daiichi Sankyo and AstraZeneca said on February 19 that the US FDA has accepted for review their application for datopotamab deruxtecan (Dato-DXd), a TROP2 directed antibody drug conjugate (ADC), for certain patients with advanced lung cancer. The application seeks the…
To read the full story
Related Article
- Daiichi Sankyo Replaces FDA Lung Cancer Filing for TROP2-Directed ADC
November 13, 2024
- New Biomarker Analysis Data Out for Daiichi Sankyo’s TROP2 ADC
September 10, 2024
- Daiichi’s TROP2 ADC Accepted for US FDA Review in Breast Cancer
April 3, 2024
- Daiichi Sankyo’s TROP2 ADC Now under Review for Breast Cancer in Japan
March 15, 2024
- EU Regulators Accept Daiichi Sankyo’s TROP2 ADC for Review in Lung, Breast Cancers
March 5, 2024
BUSINESS
- Keytruda Maintains Top-Selling Title in Japan in July-September: IQVIA
November 14, 2024
- Mitsubishi Chemical Looking for “Best Partners” for Pharma Biz: CEO
November 14, 2024
- Lilly Japan Halts Manufacturing of Strattera over Nitrosamine Impurities
November 14, 2024
- Nippon Shinyaku Bags Japan, US Rights to Atsena’s Gene Therapy
November 14, 2024
- Daiichi Sankyo Replaces FDA Lung Cancer Filing for TROP2-Directed ADC
November 13, 2024
For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…