BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, February 13, 2026
Home » Topics » Regulatory » MHLW

MHLW
MHLW RSS Feed RSS

Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 11, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


Read More
K-Sure Chairman and President Jang Young-jin Ryu (right) with KPTA Chairman Ryu Hyung-seon at the MOU signing

Korea pharma group to support exports, Korea-Japan-China trade

Sep. 2, 2025
By Marian (YoonJee) Chu
No Comments
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
Read More
K-Sure Chairman and President Jang Young-jin Ryu (right) with KPTA Chairman Ryu Hyung-seon at the MOU signing

Korea pharma group to support exports, Korea-Japan-China trade

Aug. 29, 2025
By Marian (YoonJee) Chu
No Comments
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
Read More
Concept art for adeno-associated viral-based gene therapy.

JCR’s third deal with Alexion gives rights to AAV capsids

July 15, 2025
By Marian (YoonJee) Chu
No Comments
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.
Read More
Concept art for adeno-associated viral-based gene therapy.

JCR’s third deal with Alexion gives rights to AAV capsids

July 9, 2025
By Marian (YoonJee) Chu
No Comments
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.
Read More
Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 18, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Read More
Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 14, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Read More
Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 4, 2025
By Tamra Sami
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
Read More
Yen currency symbols spilling out of drug capsule

Drug pricing scheme in Japan gets more confusing

Feb. 3, 2025
By Tamra Sami
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
Read More
3D rendering of drug linked to antibody

Japan approves Daiichi Sankyo’s Trop-2 ADC for breast cancer

Dec. 31, 2024
By Tamra Sami
Daiichi Sankyo Co. Ltd.’s trophoblast cell surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (dato-dxd), has been approved in Japan for treating adults with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
Read More
Previous 1 2 3 4 5 6 7 8 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Feb. 13, 2025.
  • Illustration of SCAN in Parkinson’s vs healthy subcortex

    SCAN is core circuit affected in Parkinson’s disease

    BioWorld Science
    Parkinson’s disease (PD) is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder,...
  • Woman and 3D brain

    Astellas’ ASP-2246 shows promise in stroke management

    BioWorld Science
    Astellas Pharma Inc. recently presented data regarding ASP-2246, a drug candidate comprised of an mRNA encoding the transcription factor NeuroD1 encapsulated in...
  • 3D illustration of skin layers

    TL1A is overexpressed in hidradenitis suppurativa

    BioWorld Science
    Despite the availability of advanced therapeutic options, about 40%-50% of patients with hidradenitis suppurativa do not achieve significant improvement in...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for Feb. 10, 2026
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing