The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
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REGULATORY MHLW to Strengthen Focus on Dementia with Budget Request for FY2013
June 22, 2012
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REGULATORY 60% Rule Applied for 3 APIs in June’s Generic Listing
June 22, 2012
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REGULATORY PMDA’s Science Committee Holds 1st Meeting; Will Work to Improve Review Quality through Exchanges with Researchers
June 20, 2012
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ORGANIZATION Products from 2nd Round of Development Requests Now Eligible for PDSC Subsidies
June 19, 2012
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REGULATORY DPJ Approves Draft Bill to Establish 3rd-Party Organization; Will Seek Discussions with Opposition
June 18, 2012
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BUSINESS Top 100 Products in FY2011: Pronounced Growth for ARB Combinations with Declining Sales of Monodrugs
June 15, 2012
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BUSINESS Sanofi, Hisamitsu to Form JV for Allergy-Related OTCs, Seen Eyeing Allegra OTC Launch
June 14, 2012
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REGULATORY Ryukaikon’s Working Team Prepares to Start Operations by End of June; Beginning with Exchange of Opinions between JPWA, NPhA
June 13, 2012
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BUSINESS Sawai Considers Leveraging “MSs with MR Qualifications” with Medipal Group
June 12, 2012
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BUSINESS University of Tokyo Hospital to Take Over Development of Takeda’s AD Treatment Candidate
June 11, 2012
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REGULATORY Expert Subcommittee Begins Discussions on Pricing of Long-Listed Drugs with Focus on Differences from Generic Prices
June 8, 2012
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BUSINESS Mr Mark Swindell Appointed Head of Specialty Care: Pfizer Japan
June 7, 2012
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ORGANIZATION JAPMS to Establish Working Group on Improvement of Drug Distribution
June 6, 2012
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BUSINESS Volume Discounts Are Naturally Expected in Price Negotiations: President Otani of Ain Pharmaciez
June 5, 2012
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REGULATORY DPJ’s Proposal on 5-Year Innovation Strategy Calls for Subsidies to Reduce Consultation, Review Fees
June 4, 2012
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BUSINESS Ono Pharmaceutical to Collaborate with UK Company in Research of Drug Targets for Allergic Diseases
June 1, 2012
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REGULATORY DPJ Proposal to Amend PAL Would Mandate Reporting of Package Inserts
May 31, 2012
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BUSINESS Kyorin Holdings to Boost Manufacturing System with Transfer of MSD Plant
May 30, 2012
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REGULATORY MHLW Sets Up Office for Promotion of Medical Innovation to Realize New 5-Year Strategy
May 29, 2012
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BUSINESS Sanofi-aventis Applies for Switch OTC Allegra, PAFSC Committee to Review on June 7
May 28, 2012
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As Japan moves into elaborate discussions on the potential reform of its cost-effectiveness assessment (CEA) in FY2024, members of a…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
The Japanese government on September 12 approved Moderna’s updated monovalent COVID-19 vaccine directed at the Omicron XBB.1.5 strain, following its…
IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
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…