- Company
- PCV21 emerges…evidence-based vaccination policies discussed
- by Whang, byung-woo Jul 7, 2025 06:10am
- "To improve pneumococcal disease prevention in Korea, an evidence-based pneumococcal vaccination policy is essential. It's crucial to evaluate the efficacy of existing vaccines and conduct cost-effectiveness assessments for new vaccines based on domestic data." Despite the implementation of the National Immunization Program (NIP), pneumococca
- Company
- PKU drug Sephience receives orphan drug designation in KOR
- by Eo, Yun-Ho Jul 7, 2025 06:10am
- Sephience, a new drug for phenylketonuria (PKU), a rare metabolic disorder, has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced so through a public notice. Specifically, the drug is indicated&160;for the treatment of hyperphenylalaninaemia (HPA) in adult and pediatric patients with ph
- Policy
- Boryung's follow-on Lenvima, 'Lenvanib,' becomes reimbursed
- by Lee, Tak-Sun Jul 7, 2025 06:09am
- Boryung has successfully obtained reimbursement listing for all dosages of 'Lenvanib Cap (lenvatinib mesylate dimethyl sulfoxide),' its follow-on drug to the anti-cancer medication Lenvima (lenvatinib mesylate, Eisai), which is used to treat conditions such as liver cancer. With the patent dispute with the original manufacturer, Eisai, sti
- Policy
- MFDS reviews GMP standards for sterile preparations abroad
- by Lee, Hye-Kyung Jul 7, 2025 06:09am
- With the Ministry of Food and Drug Safety planning to enforce revised GMP standards for sterile drug products reflecting PIC/S international standards in December, it plans to identify research tasks on items that require international harmonization by analyzing the regulatory status of reference countries. Ahead of its re-entry into PIC/S in
- Company
- ‘Need to institutionalize reinvestment of funds into R&D'
- by Kim, Jin-Gu Jul 7, 2025 06:09am
- A recommendation was made for the implementation of a system that reinvests the savings from drug price reductions by pharmaceutical and biotech companies into R&D for new drugs and ensures a fixed price during the early stages of a new drug's market launch. Professor Jeonghoon Ahn of the Department of Convergence Health Sciences at Ewha
- Policy
- MFDS reviews emergency import of 'anakinra'
- by Lee, Hye-Kyung Jul 7, 2025 06:08am
- The Ministry of Food and Drug Safety (MFDS) is reportedly conducting a review of whether to urgently import anakinra (brand name Kineret) for the treatment of severe adverse reactions associated with CAR-T cell therapy. On June 2nd, in response to an official inquiry from specialized journalists, MFDS stated, "MFDS is currently reviewing
- Company
- 'Tecentriq' reattempts at lung cancer adjuvant therapy reimb
- by Eo, Yun-Ho Jul 4, 2025 06:06am
- 'Tecentriq,' immunotherapy for cancer, will be submitted again for expanded insurance reimbursement of adjuvant therapy for lung cancer. According to our press coverage, Roche Korea applied for expanded reimbursement of its PD-L1 inhibitor Tecentriq (atezolizumab) and is awaiting review by the Cancer Disease Review Committee (CDRC) of the
- Policy
- National Office of Investigation announces rebate crackdown
- by Lee, Jeong-Hwan Jul 4, 2025 06:06am
- Amidst the National Police Agency's announcement of a special crackdown on illegal drug rebates following the launch of the new administration, the Ministry of Health and Welfare is also busy assessing the situation. The MOHW plans to actively consult with the National Police Agency if it receives a specific request for cooperation to crac
- Opinion
- [Reporter’s View] NHI finances and reimb expansions
- by Lee, Jeong-Hwan Jul 4, 2025 06:06am
- Striking a balance between improving the financial sustainability of the national health insurance system and enhancing patient access to drugs for rare and intractable diseases is a national issue. The two issues that repeatedly come into conflict have long occupied the attention of all political parties in their search for solutions, ye
- Company
- Will the external reference pricing reevals be resumed?
- by Kim, Jin-Gu Jul 4, 2025 06:06am
- Tensions are rising in the pharmaceutical and biotech industry amid speculation that the external reference pricing reevaluations may be pushed forward again in the second half of this year. The industry is reacting sensitively, as the proposal previously discussed by the consultative body could lead to large-scale drug price cuts if adopted as
