As the year 2022 draws to a close, what are managers thinking at the world’s leading pharmaceutical companies and medical device companies? We surveyed 86 managers at these companies to find out what’s on their minds.For many managers, a common…
REGULATORY
Japan to Expedite Review for Shionogi’s COVID-19 Pill: PM
Japanese Prime Minister Fumio Kishida said on February 28 that his government will “prioritize and expedite the evaluation and review” of Shionogi’s recently filed oral COVID-19 treatment S-217622 based on submitted data. S-217622 was filed in Japan on February 25,…
To read the full story
Related Article
- 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 Launches 4th-Dose COVID Jab Trial for Ages 60-Plus
July 27, 2022
- Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy
July 21, 2022
- Shionogi Begins COVID-19 Vaccine Trial in Children Aged 5-11
July 20, 2022
- Japan Shelves Decision on Shionogi’s COVID Pill with Experts at Odds, Another Session Likely Next Month
June 23, 2022
- Shionogi’s COVID Pill Up for PAFSC Review for 1st Emergency Approval
June 16, 2022
- Shionogi’s COVID-19 Vaccine Enters PII/III with Japanese Adolescents
May 17, 2022
- Shionogi’s COVID-19 Pill Improves Respiratory and Feverish Symptoms
April 26, 2022
- Large-Scale Japan Trial for Shionogi Jab Confirms No Major Safety Concerns, Increase in Antibody Titers
April 25, 2022
- Japan Inks Supply Deal for Shionogi’s COVID Pill for 1 Million People
March 25, 2022
- FDA Clears Shionogi’s COVID-19 Pill for Global PIII Study
March 17, 2022
- Shionogi’s COVID-19 Jab Non-Inferior to Pfizer Shot in Japan Booster Trial
March 7, 2022
- Shionogi Files COVID-19 Pill in Japan, Seeks Conditional Approval
February 25, 2022
- Lawmakers Mixed on Use of Conditional Approval for Shionogi’s COVID-19 Pill
February 16, 2022
- MHLW to Consider Conditional Approval for Shionogi COVID Pill: Minister
February 9, 2022
- Shionogi Looks to File COVID Pill in Japan as Early as Next Week
February 8, 2022
- Japan Mulls Early Conditional Approval for Shionogi’s COVID Pill
February 8, 2022
- Japan Won’t Give 3rd-Shot Approval for Shionogi’s Jab with Booster Trial Alone
February 1, 2022
- Shionogi’s COVID-19 Vaccine Enters Japan PIII, AstraZeneca Jab as Control
January 18, 2022
- Shionogi’s COVID-19 Pill Submission Delaying into 2022 as Recruitment Hits Snag
January 6, 2022
- Shionogi Launches Global PIII for COVID-19 Vaccine
December 28, 2021
- Shionogi’s COVID-19 Vaccine Safe and Tolerable, Increases Antibody Titers: Japan PI/II
December 8, 2021
- Shionogi Kicks Off COVID-19 Booster Trial in Japan
December 6, 2021
- Shionogi Wants to Pick Global Partner for Oral COVID-19 Drug by Year-End: President
November 2, 2021
- Shionogi Launches Japan PII/III for COVID-19 Vaccine
October 22, 2021
- Shionogi Chief Expresses Eagerness for COVID-19 Drug Rollout, PII/III to Wrap Up by Year-End
September 30, 2021
- Shionogi Kicks Off Japan PII/III Trial for Oral COVID-19 Drug
September 29, 2021
- Secure Domestic Supply of Oral COVID-19 Med: Komeito to Govt
September 27, 2021
- Shionogi to Begin PII/III Study for Oral COVID-19 Drug on Sept. 27: President
September 24, 2021
- Shionogi Gets New Oral COVID-19 Drug into Clinic in Less than 1 Year, Now Gearing Up for PII/III
September 24, 2021
- All 60 Subjects Given 1st Dose of Shionogi COVID-19 Jabs in Japan PI/PII
August 25, 2021
- Shionogi Kicks Off Japan PI/PII Study of COVID-19 Vaccine Candidate
December 17, 2020
REGULATORY
- Sanofi’s Cemiplimab Backed for Approval, Third PD-1 Inhibitor in Japan
November 29, 2022
- MHLW to Report Responses to Zolgensma Paper Retraction on Dec. 12
November 29, 2022
- MHLW Panel Endorses Teikoku’s Donepezil Tape for Alzheimer’s and More Drugs
November 28, 2022
- LDP Lawmakers’ League Holds Hearing on SaMD Review Status
November 28, 2022
- Japan to Begin Xocova Supply on Nov. 28 ahead of Schedule
November 28, 2022
Debates on the planned FY2023 off-year drug price revision are now entering the final stretch. Healthcare providers and payers have made their conflicting positions clear on the scope of products to be covered by the re-pricing, while the pharma industry…
A Japanese reimbursement policy panel on November 16 saw a continued scuffle between members representing healthcare providers and payers over…
Deloitte Tohmatsu Consulting proposed three drug pricing schemes designed to trigger the consolidation of generic makers on October 27, offering…
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…