A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
BUSINESS
SanBio to Submit Additional Data to Obtain Approval for Lead Cell Therapy
SanBio intends to submit additional data to regulatory authorities for its lead cell therapy candidate SB623 as it continues to aim for approval of this product, which failed to clear the review of a key health ministry panel. “We regret…
To read the full story
Related Article
- SanBio’s Cell Therapy Akuugo Scores Conditional Approval
August 1, 2024
- SanBio Says Its Lead Cell Therapy Could Be Shipped from 2025 If All Goes Well
June 21, 2024
- SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
- SanBio’s Lead Cell Therapy Up for Review Again on June 19
June 14, 2024
- Japan Shelves Decision on SanBio’s Lead Cell Therapy on Quality Concerns
March 26, 2024
- SanBio Chief Baffled by Planned Advisory Session over Lead Cell Therapy
March 21, 2024
- Japan Panel to Discuss Fate of SanBio’s Sakigake Cell Therapy amid Stalled Review
March 19, 2024
- Approval by January Unlikely for SanBio’s Lead Cell Therapy as Production Review Stalls
October 21, 2022
- SanBio’s Sakigake Cell Therapy Finally Filed in Japan for Traumatic Brain Injury
March 8, 2022
- Filing for SanBio’s Sakigake Cell Therapy for TBI Likely to Be Delayed
December 16, 2020
- SanBio to Start Talks with PMDA over Late-Stage Study of SB623 in Ischemic, Hemorrhagic Strokes: COO
September 17, 2020
- SanBio to Focus on Cell Therapy SB623 for Brain Injury, Stroke, Seeking Licensees for Other Indications
July 16, 2020
- Sumitomo Dainippon Pulls Plug on SanBio’s Lead Cell Therapy
December 16, 2019
- SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury
September 20, 2019
- SanBio to Move Ahead with SB623 Development in Stroke after PII Miss: President
March 26, 2019
- SanBio Vows to Continue Development of Stem Cell Therapy SB623 despite Setback: President
February 25, 2019
- Stem Cell Therapy SB623 Misses Key Target in US PIIb Study for Stroke: SanBio, Sumitomo Dainippon
January 30, 2019
- Sumitomo Dainippon, SanBio to Jointly Develop Cell Therapy Agent for Chronic Stroke in North America
September 30, 2014
BUSINESS
- Japan Ethical Drug Sales Up 3.3% in November: Crecon
January 14, 2025
- Haihe Steps into Japan Oncology Space as CEO Sees Growth Potential
January 10, 2025
- Amitiza Most Heavily Pitched Medicine for Hospital Doctors in November: Intage
January 10, 2025
- FDA Accepts Re-Submission of Izervay to Buttress Label
January 10, 2025
- Keytruda Grabs Best-Seller Crown for 15th Month in December: Encise
January 10, 2025
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up…
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…
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…