- Opinion
- [Reporter's View] Strengthening GMP for sterile drugs
- by Kim, Jin-Gu May 19, 2025 05:56am
- The government has reaffirmed its existing position on strengthening GMP standards for sterile finished drug products in December. The Ministry of Food and Drug Safety recently met with sterile drug factory managers and stated that there will be no postponement of the enforcement of the “Regulations on Drug Manufacturing and Quality Control
- 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
- Company
- Hanmi 'Rolvedon' reports US sales gain ₩18B in Q1
- by Chon, Seung-Hyun May 19, 2025 05:55am
- 'Rolvedon,' a treatment for neutropenia that Hanmi Pharmaceutical licensed out, continues to be popular in the U.S. market. Although the growth trend has stalled due to price reduction in the U.S., Rolvedon recorded over US$ 10 million in sales for six consecutive years. Rolvedon's cumulative sales amounted to KRW 200 billion in two years and si
- Company
- Ebglyss may be prescribed in general hospitals in Korea
- by Eo, Yun-Ho May 16, 2025 06:21am
- The new drug Ebglyss for atopic dermatitis may be prescribed in general hospitals in Korea. According to industry sources, Lilly Korea's interleukin (IL)-13 inhibitor Ebglyss (lebrikizumab) has passed the Drug Committees (DCs) of 9 medical institutions nationwide, including tertiary hospitals like Asan Medical Center and Sinchon Severance
- 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
- InterView
- Hemlibra shows long-term efficacy and safety in hemophilia
- by Kim, Jin-Gu May 16, 2025 06:19am
- &160;“The hemophilia patients’ only desire is to lead a normal life like everyone else. Hemlibra (emicizumab) has been found to be effective in preventing bleeding and safe in long-term follow-up studies. Moreover, it demonstrates clear bleeding prevention effects even during high-intensity exercise, significantly helping patients lead no
- 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
- Company
- AZ 'Imfinzi' leads the paradigm shift in cholangiocarcinoma
- by Whang, byung-woo May 16, 2025 06:18am
- "Introduction of Imfinzi in cholangiocarcinoma treatment can be seen as a critical advance. That a new therapy offering the possibility of long-term survival has appeared after 12 years is highly encouraging." As new treatment options for cholangiocarcinoma are introduced, a paradigm shift is said to be brought to this area, which was previou
- Policy
- Gov't begins patient advocacy service for medical incidents
- by Lee, Jeong-Hwan May 15, 2025 06:24am
- The Ministry of Health and Welfare (MOHW) will start implementing the 'patient advocacy service,' which provides a legal representative matching service for mediating disputes to strengthen the rights of patients who are victims of medical incidents, effective this month (May). The service supports the conflict between a patient and a medi
