The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
BUSINESS
Keytruda/Padcev Filed in Japan for 1st Line Bladder Cancer Treatment: MSD, Astellas
A combination therapy of MSD’s PD-1 inhibitor Keytruda (pembrolizumab) and Astellas Pharma’s antibody drug conjugate Padcev (enfortumab vedotin) has been filed for Japanese regulatory approval for the first-line treatment of bladder cancer. The drugs’ label expansions were announced by the…
To read the full story
Related Article
- Japan Panel OKs BMS ROS1 Inhibitor, Janssen Bispecific, JN.1-Targeted Nuvaxovid
September 2, 2024
- Padcev-Keytruda Approved in Europe for 1st Line Bladder Cancer
August 29, 2024
- BMS’ ROS1 Inhibitor, Janssen’s Bispecific Up for Review on Aug. 30
August 20, 2024
- Padcev-Keytruda Nears EU Nod for 1st Line Bladder Cancer
July 30, 2024
- Padcev/Keytruda Accepted for Chinese Review for 1st Line Bladder Cancer Use
March 29, 2024
- Japan Awards Priority Review for Keytruda/Padcev in Bladder Cancer: Astellas
February 19, 2024
- Astellas/Pfizer Seeks 1st Line Bladder Cancer Use for Padcev/Keytruda in EU
January 30, 2024
- Padcev/Keytruda Combo Nabs FDA Nod for 1st Line Bladder Cancer
December 19, 2023
- Padcev/Keytruda Combo Gets FDA Priority Review for Bladder Cancer
December 4, 2023
- Padcev/Keytruda Combo Wins US Accelerated Nod for First-Line Bladder Cancer: Astellas
April 5, 2023
BUSINESS
- Astellas Snags Rights to Sangamo’s AVV Capsid for Neurological Diseases
December 20, 2024
- Xocova to Be Re-Filed in South Korea with Additional Data
December 20, 2024
- JCR Commences PIII Study for Once-Weekly Growth Hormone Therapy
December 20, 2024
- Insomnia Med Quviviq Now Available in Japan: Nxera/Shionogi
December 20, 2024
- PeptiDream Gets Milestone from Novartis on PI Launch
December 20, 2024
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…
Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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…
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…
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…