Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
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REGULATORY
- 41,254 ADR Reports Received from Marketing Authorization Holders in FY2012: MHLW
August 13, 2013
- Japan NIH HQ to Orchestrate Allocation of 100 Billion Yen for R&D Budgets, Starting with FY2014 Requests
August 12, 2013
- 1st Committee on Drugs to Discuss Pediatric Indication for Kyowa Kirin’s Nesp
August 12, 2013
- MHLW Diovan Committee: 3 More Universities Give 1st Probe Updates, SMART Data Rapped “Sloppy”
August 12, 2013
- MHLW Taps 12 Experts to Serve on Diovan Study Committee; J-CLEAR’s Kuwajima, JAMS’s Sone on the List
August 9, 2013
- PMDA to Make Public Adverse Reactions Reported by Patients by Year-End
August 8, 2013
- US FDA Advisory Committee Votes Against Approval of Tolvaptan for Treatment of ADPKD
August 8, 2013
- Education Ministry Set Up Task Force for Prevention of Misconduct in Research, Will Discuss Diovan Issue
August 7, 2013
- Gov’t to Establish “Headquarters to Promote Health and Healthcare Strategy” as HQ for Japanese Version of NIH
August 6, 2013
- First Committee on Drugs Recommends Approval for Long-Acting Injectable Schizophrenia Treatment Xeplion
August 6, 2013
- Health Ministry’s Diovan Study Committee to Start on Aug 9, Minister Expects Attendance of Ex-Novartis Employee
August 5, 2013
- EAD Director to Personally Visit Hospitals to Urge Early Price Agreement
August 5, 2013
- Distribution Reform and Perpetuation of Premium for New Drug Development Are Immediate Top-Priority Issues: EAD Director Jo
August 2, 2013
- CSIMC Subcommittee Discusses Revisions of Drug Pricing Rules; Some Reps Oppose Proposed Rewards for Innovation
August 1, 2013
- “No Surprises” in TPP Negotiations; Gov’t Undecided Whether to Hold Briefing for the Drug Industry: PR Counselor Nakagawa
July 31, 2013
- Combination of Insured and Uninsured Treatments to Be a Top Priority Topic in Discussions by Council for Regulatory Reform
July 30, 2013
- PAFSC’s Second Committee Recommends Approval for Bronchial Asthma Treatment Flutiform, Others
July 29, 2013
- Half of All Drugs, Add’l Indications Approved from FY2009 to FY2012 Underwent Clinical Trials at NHO Hospitals
July 29, 2013
- MHLW-MEXT Joint Committee Agrees to Require Researchers to Store Clinical Research Data for Long Periods
July 26, 2013
- MHLW Might Submit Bill on Online OTC Sales to Extraordinary Diet Session: PFSB Head
July 25, 2013
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
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…