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 Kokando Told to Suspend Business for Up to 36 Days over Decades-Long Violations
November 14, 2022
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REGULATORY Zero Coefficient Rule Hits All 10 Premium-Granted Drugs Priced by Cost Formula in FY2022
November 11, 2022
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REGULATORY Skyrizi Auto-Doser Peak Sales Put at 30-Plus Billion Yen, Mounjaro Not on Roster: November Listing
November 10, 2022
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BUSINESS Lilly CEO Sees Donanemab’s Accelerated Nod in Coming Months, Japan Approval in 2024
November 9, 2022
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REGULATORY MOF Proposes Transition to Normal Framework for COVID Vaccines, Therapeutics
November 8, 2022
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REGULATORY MOF Renews Its Push for Full Drug Price Revision in FY2023
November 8, 2022
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BUSINESS Cartagena Act Stalls Gene Therapy Development in Japan; Pfizer, FIRM Calling for Deregulation
November 7, 2022
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BUSINESS Moderna Forging Ahead with mRNA Vaccine Programs for Difficult Viruses; CMV, HIV Jabs in Pipeline: CSO
November 4, 2022
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ORGANIZATION Priority of Japan Investment Lowered at 27% of Multinational Firms: JPMA Poll
November 2, 2022
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BUSINESS Average Price Gap for 2023 Revision Looks to Be a Bit Lower than 7.6%: Wholesalers
November 1, 2022
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REGULATORY Aricept’s Lewy Body Dementia Indication to Be Modified after Post-Launch Trial Miss
October 31, 2022
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REGULATORY Ex-Bureaucrats, Academics Trade Barbs over Macroeconomic Indexing; Will MOF Allow Rise in Drug Cost?
October 28, 2022
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ORGANIZATION Japan Needs New Forum for Top-Level Dialogue Including Global CEOs: PhRMA Chair
October 28, 2022
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BUSINESS Cancer-Savvy New CMO Eager to Extend Astellas’ Oncology Portfolio, Bag Speedy Approval
October 28, 2022
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REGULATORY Chuikyo to Discuss 2023 Off-Year Re-Pricing with Its Implementation as Premise: MHLW
October 27, 2022
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REGULATORY LDP to Launch Lawmakers’ League on Medical Adhesive Patches
October 27, 2022
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REGULATORY Pfizer Assesses Cancer Risk from Amoxan as “Acceptable” at “1 in 200,000 People”
October 26, 2022
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REGULATORY Commodity Prices Are Rising, That’s Why Full Drug Re-Pricing Needed in 2023: MOF Official
October 25, 2022
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REGULATORY Moderna’s BA.4/5 COVID Jab Up for PAFSC Review on Oct. 31
October 25, 2022
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BUSINESS Genmab to Branch Out into 2nd Disease Area beyond Cancer, Specifics to Be Unveiled Next Year: CEO
October 24, 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…