For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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REGULATORY
- MHLW to Revise Label Format, Possibly Scrap “Relative Contraindications” and “Careful Administration” Sections
March 3, 2016
- Show Us Your True Self during Surprise Manufacturing Inspections: PMDA Official
March 3, 2016
- FY2016 NHI Pricing Reform to Bring “1 Victory, 1 Defeat, 1 Draw” for Industry: MHLW Official
March 3, 2016
- MHLW Official Calls for Surprise Checks during Notified Inspections
March 2, 2016
- MHLW OKs 38 New APIs in 2015
March 2, 2016
- MHLW’s Onishi Urges Pref. Officials to Prep for Drug Price Survey toward 2017 Revision
March 2, 2016
- Japan Generic Use Rate at 59.7% in October 2015: MHLW
March 2, 2016
- MHLW to Boost Confirmation Process for Review Panel Members’ Claims on Money Received from Drug Makers
March 1, 2016
- MHLW Approves Add’l Indications for Halaven, Rituxan; Opdivo Now OK’ed for Previously Treated Patients
March 1, 2016
- MHLW Panel Backs Orphan Drug Designation for Opdivo for Hodgkin’s Lymphoma
February 29, 2016
- MHLW Advisory Panel Supports Novartis’s Ceritinib, AZ’s Osimertinib
February 29, 2016
- PMDA Reviewing Risks of Intestinal Obstruction for Loxoprofen
February 29, 2016
- Kaketsuken Allowed to Ship Japanese Encephalitis Vaccine
February 29, 2016
- Drug Makers, Distributors Rolling Up Their Sleeves for Mandatory Barcode Labeling
February 26, 2016
- MHLW Grants Orphan Designation to Takeda’s MM Drug Ixazomib
February 26, 2016
- MHLW Panel Backs Approval of Sanofi’s Antiepileptic Drug, OKs Cymbalta’s New Indication by Unanimous Vote
February 25, 2016
- Industry Must Find Logical Reasons to Dodge Re-Pricing amid Growing Pressure on Huge Sellers
February 24, 2016
- Possible Price Slash for Big-Sellers Looms as 2017 Tax Hike Nears; All Eyes on Opdivo
February 24, 2016
- MHLW Taskforce on Vaccines and Blood Products Holds 2nd Meeting
February 23, 2016
- Pricing Debate Spills Over into MHLW Safety Panel, Member Warns Opdivo Costs Could Jeopardize State Finances
February 22, 2016
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Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
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…