- Company
- Ziihera receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 20, 2025 05:54am
- The first HER2 bispecific antibody drug Ziihera has received an orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced so through the first orphan drug designation in the new year. Its specific indication is for the treatment of adult patients with previously treated unresectable locally advanc
- Company
- [Reporter' View] Results from J.P. Morgan Conference
- by Lee, Seok-Jun Jan 20, 2025 05:53am
- The Annual J.P. Morgan Healthcare Conference (hereafter J.P. Morgan Conference) has ended. It is the largest funding event in the pharmaceutical and biotech industry and is held in January every year. Many Korean companies have also participated in the event, to the extent that many key R&D people in the Korean pharmaceutical and biotech ind
- Opinion
- [Reporter's View] Improving rare disease care environment
- by Eo, Yun-Ho Jan 17, 2025 05:54am
- A few patients can only make a small noise. Despite the need for the improvement of the rare disease treatment environment, which has risen year after year, the voice of its patients that implore difficulties has never ceased to exist. In particular, there are cases where a drug is available, but due to the small number of eligible patien
- Policy
- Drug expenditures surge due to the use of high-priced drugs
- by Lee, Tak-Sun Jan 17, 2025 05:53am
- Drug expenditures have risen significantly in 2023 due to the rising cost of high-priced anticancer drugs and rare disease treatments. Due to the aging population increasing the expenditures spent on treating chronic diseases, an urgent need has arisen to come up with a measure to reduce drug expenditures. According to the National Health Ins
- Company
- Expanded reimb for 'Zejula'
- by Son, Hyung Min Jan 17, 2025 05:53am
- Following the reimbursement expansion of Zejula for ovarian cancer, patient access to treatment has been improved. Experts suggest that Zejula will be more widely used in clinical practices based on demonstrated benefits in efficacy and safety in long-term treatment studies. On January 16, Takeda Pharmaceutical Korea held a press conferen
- Policy
- Pulmonary fibrosis drug 'Ofev' under consideration for reimb
- by Lee, Tak-Sun Jan 17, 2025 05:53am
- As 'Ofev Soft cap (nintedanib),' a treatment for pulmonary fibrosis, has been approved for reimbursement appropriateness, latecomer drugs are projected to enter the market quickly. Following the expiration of Ofev's usage patent, latecomer companies are anticipated to prepare for launching their drugs. According to industry sources on J
- Policy
- Innovative Pharmaceutical Company certification to change
- by Lee, Jeong-Hwan Jan 17, 2025 05:53am
- The Ministry of Health and Welfare will improve the certification system for innovative pharmaceutical companies to a 'certification evaluation score system' that will increase the proportion of new drug research and development (R&D) and change the disqualification criteria to a point-based score system. The MOHW plans to issue an admin
- Company
- Ultomiris is reimbursed for aHUS in Korea
- by Son, Hyung Min Jan 16, 2025 06:14am
- Ultomiris has been reimbursed in Korea for atypical hemolytic uremic syndrome (aHUS) since January. While experts have welcomed the news of its reimbursement, they have also raised the need for systematic improvements to the stringent conditions for reimbursement, including the preliminary review requirement. On the 10th, AstraZeneca Kore
- Company
- Last year's pharma export sales recorded KRW 11T
- by Kim, Jin-Gu Jan 16, 2025 06:14am
- Last year's export sales of Korea-made pharmaceuticals amounted to US$ 7.5 billion (approximately KRW 11 trillion), up 29% from the previous year. Analysis indicates that a significant increase in biopharmaceutical exports of Samsung Biologics and Celltrion has contributed to the growth. The largest exported country was the United State
- Company
- Elahere receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 16, 2025 06:13am
- The new ovarian cancer drug Elahere has received an orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through the first orphan drug designation announcement of the new year. Specifically, the drug is indicated as monotherapy in adult patients with folate receptor-alpha (FR
