Novo Nordisk’s weight-loss medication Wegovy (semaglutide) was approved in Japan in March. While it skipped the May round of reimbursement listing, physicians eagerly await the arrival of what would be the first new obesity drug in three decades. Other companies…
REGULATORY
Shionogi’s COVID Pill Up for 3rd Round of Discussion for Emergency Approval on Nov. 22
Health ministry expert panels will meet on November 22 to re-discuss whether Japan’s first emergency approval should be granted to Shionogi’s oral COVID-19 treatment ensitrelvir. It will be the third such review, this time around with additional PIII data, which…
To read the full story
Related Article
- Japan Govt to Purchase Another 1 Million Courses of Xocova
December 14, 2022
- Japan Should Hone Emergency Approval Scheme Based on Xocova Example
November 28, 2022
- Shionogi Chief Defends Xocova Data, Eager to Prove Benefits in Clinical Settings
November 25, 2022
- Japan Grants 1st Emergency Approval to Shionogi COVID Pill Xocova
November 24, 2022
- Shionogi to Test COVID Pill as Prophylaxis for Household Contacts from December
October 13, 2022
- Shionogi’s COVID Pill Hits Main Goal in PIII, Discussion on Regulatory Path to Follow
September 29, 2022
- Shionogi Eyes PIII Topline Readout for COVID Pill in Aug-Sept., Sticks to H1 Approval Plan
August 2, 2022
- Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy
July 21, 2022
- Japan Shelves Decision on Shionogi’s COVID Pill with Experts at Odds, Another Session Likely Next Month
June 23, 2022
REGULATORY
- Japan Approves Label Expansions for Ultomiris, Skyrizi, Vanflyta
May 26, 2023
- Expert Panel Meeting Canceled Due to Lack of Coordination: MHLW Official
May 26, 2023
- Expedite Introduction of High-Priority Vaccines into National Schedule: Trade Groups
May 25, 2023
- Orphan Tag Granted to Opdivo, Leniolisib, and 6 More APIs
May 24, 2023
- LDP Pharma Study Group Proposes Removing Cap for Social Security Costs
May 23, 2023
President Joe Biden enacted the Inflation Reduction Act (IRA) on August 16, 2022, significantly affecting Medicare prescription drug coverage and introducing targeted changes to Medicaid, the Children’s Health Insurance Program, and private health insurance. In January 2023, the Centers for…
Japan’s health ministry on April 27 presented an outline of a report to be compiled next month by its key…
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…