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REGULATORY
- 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
- CSIMC Approves Questionnaire to Determine Impact of FY2012 Medical Fee Revision on Generic Drug Use
July 25, 2013
- Diovan Study Committee to Hold 1st Meeting in Early August: Minister
July 24, 2013
- Stivarga Effectively 1st Drug Offered under Japan’s “Compassionate Use” System
July 23, 2013
- Pilot Program for Japan-Version “Compassionate Use” System to Begin at National Cancer Center
July 23, 2013
- 1st Committee to Discuss Approval of New Products Including Janssen’s Extended Release Schizophrenia Treatment
July 23, 2013
- MHLW OKs AMD Clinical Research Using iPS Cells
July 22, 2013
- MHLW Mulls “Ultra-Orphan” Drug System; Designation Might Become Possible with Pre-Clinical, Healthy Subject Data
July 22, 2013
- US Aims for Lifting of Ban on Mixed Care: Prof. Murakami of Yamagata University
July 22, 2013
- South Korean MOHW Officials Announce Roadmap for South Korea to Become No. 7 Worldwide in New Drug Development by 2020
July 19, 2013
- CSIMC Begins Full-Scale Discussions on FY2014 NHI Price Revision; Generics as Well as Long-Listed Original Drugs May Face Further Price Cuts
July 19, 2013
- eCTD Progresses to Step 4 at ICH in Brussels
July 18, 2013
- 2nd Committee on Drugs to Discuss Approval for Asthma Treatment Flutiform on July 26
July 17, 2013
- MHLW, US FDA to Exchange Information with a View to Standardizing Review Guidelines for Regenerative Medicines
July 17, 2013
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Earlier this month, Health Minister Keizo Takemi called on the top executives of 13 major generic makers to restructure the industry with a product consolidation target of “around five companies per API.” While a variety of restructuring options are conceivable,…
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…
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…