The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
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- Will Legal Regulation Propel or Stymie Clinical Research? “Risk-Based” Approach Holds Key
January 13, 2015
- Can Pharmas and Wholesalers Work to Dispel “Negative Primary Margins on Sales”?
December 22, 2014
- April-Sept. Earnings Signal Watershed in Japan’s Shift to Generics
December 15, 2014
- Wonder Drug? Savior? Avigan Clinical Trial for Ebola May Not Provide Clear-Cut Answer
December 5, 2014
- Torii Eager to Carve Out New Market with Japan’s 1st Sublingual Allergen Immunotherapy
November 25, 2014
- Was Weak Yen a Plus for April-Sept. Earnings? Profits Partly Canceled Out by Higher R&D, Import Costs
November 18, 2014
- JPWA’s Uniform Tax Representation Will Benefit Wholesalers and Customers Alike
November 10, 2014
- Can a More-Open ICH Maintain “Tri-Polar” Leadership? - Key Focus at Lisbon Meeting
November 5, 2014
- Ex-Health Minister Tamura’s Clout Likely to Grow in Nagatacho
October 14, 2014
- MHLW Has Trick Up Its Sleeve to Skirt 3 Straight Years of “Full-Scale” NHI Price Revisions
October 6, 2014
- Revised PAL to Embrace “Deeper” Safety Measures, Yet Also Escape Clauses to Ease Company Burdens
September 29, 2014
- Series of CRPC Drugs Make Japan Debut, Expanded Indications Key to Success
September 24, 2014
- Picture of Future Regulations on Investigator-Led Clinical Research Emerging
September 9, 2014
- With No Pilot at Helm, Pharma Industry Embroiled in Confusion with Voluntary Funding Disclosures
September 1, 2014
- Wholesalers’ Q1 Earnings Remain Positive, Medical Fee Cut Rule Seen to Boost Accuracy of Financial Results in Sept.
August 25, 2014
- Japanese Drug Makers Working to Increase Pace of Drug Discovery by Optimizing Operations at Research Centers
August 18, 2014
- PMDA Sets Target Review Times for Partial Changes to Generic Approval - A New Way to Underpin Stable Supply
August 4, 2014
- Competition Fuels Personalized Medicine Market, First-Line Positions Eyed for Xalkori, Alecensa
July 28, 2014
- Can New Fast-Track Review System Perk Up Drug Makers’ Development Drive in Japan?
July 7, 2014
- June Reimbursement Listing Could Mark Watershed in Japan Generic Market
July 1, 2014
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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…