- Company
- Industry eyes myelofibrosis drug Ojjaara’s reimb progress
- by Eo, Yun-Ho Nov 22, 2024 05:55am
- Interest is gathering on the insurance reimbursement of Omjjara, a targeted therapy for myelofibrosis. According to industry sources, GSK Korea is preparing to submit a reimbursement application for its myelofibrosis drug, Ojjaara (momelotinib) in Korea. The company is expected to submit its application next month (December).&160; Spe
- Company
- Latecomer psoriasis treatment 'Bimzelx' launches
- by Whang, byung-woo Nov 22, 2024 05:55am
- UCV Korea has launched Bimzelx (ingredient: bimekizumab) for treating psoriasis and is set to challenge the market. Although existing psoriasis treatments have taken a share of the market, the company will target unmet needs based on the drug's new mechanism. UCB Korea held a media session on November 20 to celebrate the launch of Bimz
- Policy
- Korea’s 2nd GIFT drug Nefecon is approved in KOR
- by Lee, Hye-Kyung Nov 22, 2024 05:55am
- Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug, has been approved in Korea. The Ministry of Food and Drug Safety approved Nefecon on the 18th. Nefecon is used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who
- Opinion
- [Desk's View] Re-evaluation of eye drops
- by Lee, Tak-Sun Nov 22, 2024 05:55am
- The government has established reimbursement criteria for single-use ophthalmic solutions, including hyaluronic acid eye drops for conditions like dry eye syndrome. A year has passed after the primary result of the re-evaluation regarding the reimbursement appropriateness for hyaluronic acid eye drops were released in September 2023. When
- Company
- ‘Global Bio M&A Trends: Fewer New Drugs, More CDMOs’
- by Kim, Jin-Gu Nov 22, 2024 05:55am
- The global pharma-bio M&A trend is showing a distinct trend of 'risk aversion'. Due to the macroeconomic impact, investments in stable areas became more active, while investments in high-risk, high-return areas have plummeted.&160; This explains the sharp decline in M&A related to new drug development, which is high-risk and the increase in
- Opinion
- [Contribution] On MFDS’s new drug approval fee hike
- by Whang, byung-woo Nov 21, 2024 05:46am
- The Ministry of Food and Drug Safety recently announced a significant rise in its new drug approval fee to KRW 410 million. In Korea, the new drug approval fee had remained very low at KRW 8.83 million for decades, compared to the US FDA's KRW 5.3 billion, the European EMA's KRW 490 million, and the Japanese PMDA's KRW 430 million.&160;
- InterView
- ‘Improve new drug access to treat rheumatoid arthritis'
- by Son, Hyung Min Nov 21, 2024 05:46am
- “Rheumatoid arthritis is not just a painful disease, but a disease that can cause direct damage to the joints. Patients need to start treatment with good treatments in a timely manner, but their access to new drugs is still limited. Switching between JAK inhibitors should be allowed freely so patients can receive personalized treatment.”
- Policy
- CKD drug Kerendia seeks indication expansion in KOR
- by Lee, Hye-Kyung Nov 21, 2024 05:46am
- Bayer Korea's Kerendia (finerenone), which is used to treat adult patients with chronic kidney disease with type 2 diabetes, will enter Phase III clinical trials in Korea to expand its indication. On the 20th, the Ministry of Food and Drug Safety (MFDS), approved a ‘randomized clinical trial to determine the efficacy and safety of finere
- Company
- New CGRP antagonist 'eptinezumab' expected to be marketed
- by Eo, Yun-Ho Nov 21, 2024 05:46am
- Yet another CGRP antagonist drug for migraine is expected to be marketed. Lundbeck's 'eptinezumab (Vyepti),' a CGRP antagonist for the preventive treatment of migraine, showed positive results in the global Phase 3 clinical trial in Asia involving Koreans. The drug is expected to enter South Korea quickly based on this result. Lundbec
- Policy
- Strengthed regulations on human drug use in vet clinics
- by Lee, Jeong-Hwan Nov 20, 2024 06:08am
- A bill that requires frontline pharmacies to record detailed distribution details on human specialty drugs sold to veterinary hospitals has passed the Bill Review Subcommittee review. Although there was a lot of disagreement over the bill between the professions subject to the regulation - the pharmacists and the veterinarians - the Healt
