- Opinion
- [Reporter’s View] Real test begins for K-CDMOs
- by Son, Hyung Min Sep 15, 2025 06:01am
- In the midst of global supply chain restructuring, Korea’s CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) industries are emerging as new growth drivers for the biopharmaceutical sector. The shift away from China is acting as an opportunity factor, while independent achievements base
- Company
- MSD vs Medihelpline PMS contract dispute goes on trial
- by Eo, Yun-Ho Sep 12, 2025 06:19am
- A legal battle is looming between multinational pharmaceutical company MSD Korea and CRO firm Medihelpline over payment disputes related to a PMS outsourcing contract. According to Dailypharm coverage, MSD recently filed a lawsuit against Medihelpline, demanding the return of part of the advance payments made under a PMS outsourcing contract.
- Policy
- HIRA to disclose all off-label drug approval/disapprovals
- by Lee, Tak-Sun Sep 12, 2025 06:19am
- All approval decisions regarding off-label drugs will be disclosed on the official website from now on. Currently, only non-approved general drugs are listed publicly, but going forward, both approved and non-approved cases will be made available in order to reduce the administrative burden on medical institutions submitting applications.
- Company
- Anticipation for the survival-extending effects of Fruzaqla
- by Hwang, byoung woo Sep 12, 2025 06:18am
- A new option has emerged for fourth-line metastatic colorectal cancer (CRC) treatment. Previously, there were no more drugs available to use, increasing expectations in clinical practice. In Korea, the survival-extending effect of Fruzaqla (fruquintinib) is evaluated as a potential solution to the unmet needs of CRC patients. The number of p
- Policy
- MOHW will reform system for certifying innovative companies
- by Lee, Jeong-Hwan Sep 12, 2025 06:18am
- The Ministry of Health and Welfare (MOHW) plans to announce a legislative notice in October for reforms to the Korea Innovative Pharmaceutical Company certification system, aiming to implement the changes in January next year. The reform plan includes converting the certification system into a point-based structure and establishing separa
- Policy
- Improvement to the post-marketing management for pharma
- by Lee, Tak-Sun Sep 11, 2025 06:11am
- A comprehensive discussion regarding the post-marketing management program of pharmaceuticals, including actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement, is anticipated once research results become available at the end of this year. Improvement plans to the actual transaction price-b
- Policy
- Generic dispensing, collusion ban pass legislative committee
- by Lee, Jeong-Hwan Sep 11, 2025 06:11am
- On September 10, the National Assembly’s Legislation and Judiciary Committee passed two amendments to the Pharmaceutical Affairs Act. One expands the post-notification method for generic substitution at pharmacies to include information systems operated by the Ministry of Health and Welfare and the Health Insurance Review and Assessment Ser
- Company
- Greenlight for launching KRAS inhibitors for lung cancer
- by Son, Hyung Min Sep 11, 2025 06:10am
- Next-generation KRAS inhibitors are emerging as a new game-changer in the lung cancer treatment market. While first-generation KRAS inhibitors, such as Amgen's Lumakras and BMS's Krazati, have been commercialized, concerns have risen regarding their limitations in terms of resistance and restricted indications. As a result, global pharmaceut
- Company
- ‘HIV Is No Longer a Target of Discrimination'
- by Hwang, byoung woo Sep 11, 2025 06:09am
- While advances in antiretroviral drugs have made human immunodeficiency virus (HIV) a manageable chronic disease, experts point out that social awareness remains stagnant. Amid the reality that the suicide risk among infected individuals in Korea is nearly twice as high as among non-infected individuals, academia, patient groups, and industry
- Company
- Could Spravato resolve treatment-resistant depression?
- by Hwang, byoung woo Sep 11, 2025 06:09am
- As Korea ranks first in suicide rates among OECD countries, the need for treatment support for ‘treatment-resistant depression’ is being emphasized. Experts stress the need for alternatives in treating treatment-resistant depression, a condition known to have a sevenfold higher risk of suicide attempts compared to general depression. On
