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2025-09-09 23:09
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Policy
Amgen¡¯s SCLC drug tarlatamab soon to be approved in KOR
by
Lee, Hye-Kyung
May 26, 2025 05:55am
The approval of Amgen's new drug for small cell lung cancer, tarlatamab (U.S. brand name Imdelltra), is imminent in Korea. According to industry sources on the 23rd, the Ministry of Food and Drug Safety has completed its safety and efficacy review for tarlatamab. The MFDS's completion of the review means a new drug approval will follow
Policy
Myung In¡¯s Nuvigil first generic listed for reimb in Korea
by
Lee, Tak-Sun
May 23, 2025 05:52am
Myung In Pharm¡¯s first generic version of the narcolepsy drug Nuvigil (amodapine) is expected to be sold in earnest following its reimbursement listing in June. Currently, narcolepsy treatments are primarily composed of two ingredients: modafinil and amodafinil. With Mitsubishi Tanabe Pharma's ' 'Wakix (pitolisant)' recently withdrawi
Policy
Govt-ind sees consensus on 'AI-based new drug governance'
by
Lee, Jeong-Hwan
May 22, 2025 06:09am
The current administration has promised support and promotion for the establishment of a national governance system for AI-based new drugs, which the domestic pharmaceutical industry has called for the attention of the presidential election candidates. The National Bio Committee, which reports directly to the president, has selected AI-
Policy
'AI-enabled stem cell for pediatric epilepsy proves effect'
by
Lee, Hye-Kyung
May 21, 2025 06:36am
A new treatment possibility has opened up for pediatric epilepsy patients who have shown little response to existing treatments. The Korea Health Industry Development Institute (President: Soondo Cha) announced on the 19th that Professor Hoon-Chul Kang¡¯s research team at Yonsei University Severance Children's Hospital has successfully disco
Policy
Citus generics price raised, Ameliebou Inj huge price cut
by
Lee, Tak-Sun
May 20, 2025 06:00am
Prices of Citus generic drugs will be raised. As the price of original Citus has been adjusted, the prices of generic drugs that were reimbursement-listed in January have been recalculated. Meanwhile, the price of Samsung Bioepis' Lucentis biosimilar 'Ameliebou Inj' has been substantially cut, resulting in a significant difference from the or
Policy
MFDS to review reference drug application every 2 months
by
Lee, Hye-Kyung
May 20, 2025 05:59am
The change in the procedure for selecting reference drugs for pharmaceutical equivalence tests is being well received by the domestic pharmaceutical industry. The Ministry of Food and Drug Safety recently announced a revision to the 'Guideline for Selecting Reference drugs for Pharmaceutical Equivalence Tests' and is seeking opinions on the c
Policy
GSK starts domestic trial on its B7-H3-targeted ADC
by
Lee, Hye-Kyung
May 19, 2025 05:56am
GSK's antibody-drug conjugate (ADC) drug candidate 'GSK5764227,' designated as a breakthrough therapy by the US FDA last year, will begin clinical trials in Korea. On the 16th, the Ministry of Food and Drug Safety approved GSK's application for a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and clinical a
Policy
New drugs Bimzelx and Adempas reimbursed from June
by
Lee, Jeong-Hwan
May 19, 2025 05:55am
UCB Pharma Korea's Bimzelx and Bayer Korea's Adempas will be reimbursed by national health insurance starting on the first of next month. The Ministry of Health and Welfare announced an amendment to the Details on the standards for application of drug reimbursement (drugs). Bimzelx is a monoclonal antibody drug that targets both interl
Policy
Trodelvy and new drugs reached an agreement with the NHIS
by
Lee, Tak-Sun
May 16, 2025 06:21am
Three new drugs, including the triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan), have completed negotiations with the National Health Insurance Service (NHIS) and are about to be included in the reimbursement list. These drugs passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursem
Policy
CDDC to discuss partial reimb of anticancer drug combos
by
Lee, Tak-Sun
May 16, 2025 06:18am
The Health Insurance Review and Assessment Service announced today (14th) that it held a Cancer Disease Review Committee meeting and discussed the list of drugs eligible for partial reimbursement as anticancer drug combination therapies, as it had recently announced. The reimbursement standard for anticancer drugs will be revised starting ne
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