- Opinion
- [Reporter's View] KRW 400m drug approval fee
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Now, the new drug approval fee in South Korea costs KRW 410 million. On September 9th, 2024, the Ministry of Food and Drug Safety (MFDS) issued an administrative notice of 'Revision to the Regulation of Fees for Pharmaceutical Approval.' The revision specifies details of increasing the new drug approval fee to KRW 410 million and reducing th
- Product
- Wegovy outpatient prescriptions ↓…pharmacy burden↑
- by Jung, Heung-Jun Feb 12, 2025 06:13am
- Wegovy, whose sales suffered due to inventory shortage in pharmacies, has now become an intractable inventory four months after its launch in Korea. Wegovy is a self-injectable drug that requires refrigeration and is a non-returnable product. Each unit costs tens of thousands of won, so pharmacies bear a heavy burden if it becomes a dead
- Policy
- P3T for Sanofi’s Itepekimab in rhinosinusitis approved
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Sanofi Aventis' biological drug 'Itepekimab' is entering Phase III trial in Korea to secure an indication for chronic rhinosinusitis following chronic obstructive pulmonary disease (COPD). On the 10th, the Ministry of Food and Drug Safety approved Sanofi’s 52-week Phase III randomized, double-blind, placebo-controlled, parallel-group cli
- Company
- Will 'Verzenio' be reimb for early breast cancer in 2025?
- by Eo, Yun-Ho Feb 12, 2025 06:13am
- The industry eyes whether 'Verzenio,' with expanding reimbursement challenges, will obtain results this year. According to sources, Lilly Korea's CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the upcoming Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) for its
- Policy
- Boryung’s Lenvima generic approved in Korea
- by Lee, Hye-Kyung Feb 11, 2025 06:03am
- Boryung has received approval for a generic version of the liver cancer treatment 'Lenvima Cap (lenvatinib).' It received approval as an incrementally modified drug (new salt version) and added a 12 mg dose, which is not available with the original drug. The Ministry of Food and Drug Safety (MFDS) approved three items on the 6th, includin
- Company
- 'Lorviqua' accepts DREC condition…negotiations to start
- by Eo, Yun-Ho Feb 11, 2025 06:02am
- The final review process is about to begin for expanded reimbursement of the non-small cell lunger cancer treatment 'Lorviqua' as a first-line treatment. According to industry sources, Pfizer Korea accepted the condition of 'accepting the drug price below the evaluated amount' suggested by the Drug Reimbursement Evaluation Committee (DREC
- Company
- Mitsubishi Tanabe Pharma sold to private equity fund
- by Whang, byung-woo Feb 11, 2025 06:02am
- The sale of Japanese pharmaceutical company Mitsubishi Tanabe Pharma to a global private equity firm is expected to bring changes to its Korean branch as well. Although the company is being sold, it is not being sold by business unit, so its effect on the overall market is expected to be small. Rather, the sales are expected to increase suppo
- Policy
- KAPO ‘CDDC should pass Keytruda’s reimb extension agenda’
- by Lee, Tak-Sun Feb 11, 2025 06:02am
- A patient group has called for the immediate expansion of the coverage of the immuno-oncology drug 'Keytruda'. With the National Health Insurance Service's Cancer Disease Deliberation Committee scheduled to meet on the 12th, the group is asking for the establishment of reimbursement standards to strengthen patient access to treatment. In
- Opinion
- [Reporter’s View] Trodelvy makes way to reimb in KOR
- by Eo, Yun-Ho Feb 10, 2025 05:51am
- The wait was worth it. The triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan-hziy) has passed the Drug Reimbursement Evaluation Committee review, nearly 15 months after passing the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review. The most promising aspect of the news
- Company
- OliX licenses out RNA-based MASH drug technology to Lilly
- by Feb 10, 2025 05:50am
- OliX, a company developing RNA-based new drugs, has transferred its metabolic dysfunction-associated steatohepatitis (MASH) and obesity drug candidate to the multinational pharmaceutical company Eli Lilly. On the 7th, OliX announced that it had signed a joint development and technology export agreement with Lilly for its MASH and obesity
