While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…
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REGULATORY MHLW to Boost Orphan Program to Fuel New Drug Development: FY2023 Budget Request
August 23, 2022
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REGULATORY After Repeated Scandals, PMDA Sets Up New Division to Provide GMP Inspection Know-How to Prefectures
August 22, 2022
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REGULATORY Operational Issues of Emergency Approval Scheme Will Be Addressed If Needed: Pharma Bureau Chief
August 19, 2022
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BUSINESS Lagevrio Joins NHI Price List, Normal Distribution to Start Once Ready
August 19, 2022
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BUSINESS Incyte Japan Urges Reward for Innovation in Rare Diseases as Pemazyre Filed for Ultra Orphan Cancer
August 18, 2022
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ORGANIZATION JaDHA Hopes to Issue First Policy Proposal to Solve Digital Health Challenges by Year-End: Chairman
August 17, 2022
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REGULATORY AZ’s Asthma Drug Tezepelumab Up for MHLW Panel Review on August 29
August 17, 2022
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REGULATORY Generic Makers Flock to Samsca’s Heart Failure Market after Patent Invalidated; Gx Listing Expected in December
August 16, 2022
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REGULATORY Authorized Generics Approved for Nexium, Samsca, Lipitor, Careram
August 16, 2022
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REGULATORY First Generics for 5 APIs Approved towards December Listing, with 8 Firms for Nexium
August 16, 2022
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REGULATORY Lilly’s GIP/GLP-1 Receptor Agonist Up for PAFSC Review on August 25
August 15, 2022
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REGULATORY 26 Suspected Violations in Detailing Activities Reported in FY2021: MHLW
August 12, 2022
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BUSINESS Sumitomo Pharma to Rev Up R&D for Regenerative Medicine, CNS towards Later 2030s
August 12, 2022
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REGULATORY Chuikyo OKs Lagevrio, Voxzogo, Enjaymo, and More for August Listing, BioMarin Med with Biggest Peak Sales Outlook
August 10, 2022
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REGULATORY Rybelsus Faces 2.5-2.6% Price Cut in November under CEA Scheme; No Change for Cabometyx
August 10, 2022
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BUSINESS Sumitomo Drops 100 Billion Yen Diabetes Sales Goal as Trulicity Collab Ends
August 10, 2022
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BUSINESS Yen’s Fall Reaps 10 Billion Yen-Plus Gain on Sales for 5 Japan Makers, Takeda Gets 8.8 Billion Yen: April-June
August 9, 2022
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BUSINESS Pfizer Seeks Japan Nod for Omicron-Adapted Bivalent Jab
August 9, 2022
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BUSINESS Single-Wholesaler Distribution Unlikely to Constitute Antimonopoly Law Violation: Expert
August 8, 2022
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REGULATORY LDP Project Team to Make Proposals for Japan-Moderna Deal
August 8, 2022
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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…
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…