Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
REGULATORY
Ronapreve Up for PAFSC Review for Preventive Use on Nov. 4
Chugai Pharmaceutical’s antibody cocktail Ronapreve (casirivimab + imdevimab) could be approved for preventive use in COVID-19 as early as November 4 on the heels of discussions at a key advisory meeting on the day. The health ministry said on October…
To read the full story
Related Article
- Japan Approves Ronapreve to Prevent Symptomatic COVID-19
November 5, 2021
- Ronapreve Clears Key Panel for COVID-19 Prevention, SC Use
November 5, 2021
- Chugai Seeks Japan Nod for Ronapreve in Prophylaxis, Asymptomatic COVID-19
October 12, 2021
- COVID-19 Antibody Cocktail Given to 13,000 in Japan by August-End: MHLW
September 10, 2021
- Chugai to File Antibody Cocktail for COVID-19 Prevention among Close Contact Individuals
August 27, 2021
- Japan Approves COVID-19 Antibody Cocktail, 1st Drug for Mild Cases
July 20, 2021
- Chugai’s Antibody Cocktail Up for PAFSC Review on July 19, 4th COVID-19 Drug If Approved
July 13, 2021
- Chugai Files Regeneron’s Antibody Cocktail in Japan
June 30, 2021
- Chugai Presses on with Japan Development of 3 COVID-19 Drugs, Aims for Antibody Cocktail Filing in 2021: President
May 14, 2021
- Chugai, Japan Govt Cut Supply Deal for COVID-19 Antibody Cocktail
May 11, 2021
- Chugai Eyes Japan Submission for COVID-19 Antibody Cocktail by Year-End
April 23, 2021
- Chugai to Develop Regeneron’s COVID-19 Antibody Cocktail in Japan
December 11, 2020
- Chugai, Roche Discussing Japan Development of Regeneron's COVID-19 Antibody Cocktail
October 16, 2020
REGULATORY
- LDP’s New Fiscal Reform HQ to Release Draft Report by Late May
April 4, 2025
- 3-Party Talks Fail to Reach Specifics on OTC-Like Drugs
April 4, 2025
- Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
April 3, 2025
- JIHS Now Up and Running as Japan Version of CDC
April 3, 2025
- PMD Act Amendment to Enter Diet Debate; Parallel Deliberations Planned for Bill to Scrap Off-Year Revisions
April 3, 2025
Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
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…
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…