- Policy
- Atopic dermatitis drug Ebglyss reimbursed from next month
- by Lee, Tak-Sun Jun 16, 2025 06:03am
- With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ‘Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)’ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis
- Policy
- Roche’s SMA drug Evrysdi Tab approved in Korea
- by Lee, Hye-Kyung Jun 16, 2025 06:03am
- The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ‘Evrysdi 5 mg (risdiplam).’ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet fo
- Policy
- Ruling party proposes bill for free HPV vaccination
- by Lee, Jeong-Hwan Jun 13, 2025 06:02am
- The Democratic Party of Korea has submitted a bill to the National Assembly to significantly expand the scope of Korea’s National Immunization Program for human papillomavirus (HPV) vaccines. The bill proposes to provide free HPV vaccinations to all males and females aged 12 to 26, regardless of gender or income level. This legislatio
- Policy
- Measures to reduce industry burden for stronger GMP
- by Lee, Hye-Kyung Jun 12, 2025 06:04am
- With the Ministry of Food and Drug Safety set to enforce the revised GMP standards for aseptic drugs reflecting the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards from December, measures are being prepared by the industry to reduce its burden. Ahead of its rejoin into PIC/S in 2023, the MFDS announced the “Regu
- Policy
- Qlaris starts Phase II trial for its glaucoma drug in KOR
- by Lee, Hye-Kyung Jun 12, 2025 06:03am
- Qlaris Bio, a US biotech company, is conducting a Phase II clinical trial in Korea for 'QLS-111,' a drug candidate for primary open-angle glaucoma (POAG) and ocular hypertension (OHT). On the 5th, the Ministry of Food and Drug Safety approved a randomized, active-controlled, multicenter, double-blind, preliminary study to evaluate the saf
- Policy
- Speculation high over the new Minister of Health and Welfare
- by Lee, Jeong-Hwan Jun 10, 2025 06:05am
- Speculation is rife over who will become the first Minister of Health and Welfare in Lee Jae-myung's administration. Eun-kyeong Jeong, former Commissioner of the Korea Disease Control and Prevention Agency, who served as the chief campaign advisor for Democratic Party candidate Jae-myung Lee, is widely expected to be appointed as the nex
- Policy
- BMS’s next-gen targeted drug repotrectinib approved in KOR
- by Lee, Hye-Kyung Jun 9, 2025 05:51am
- BMS Pharmaceuticals' ‘Augtyro Cap (repotrectinib),' which is regarded a next-generation targeted therapy for lung cancer, has been approved in Korea. On the 5th, the Ministry of Food and Drug Safety granted marketing authorization for 2 items - Augtyro Cap 40 mg and 160 mg. Specifically, repotrectinib is indicated as: ▲treatment for
- Policy
- Lee 'will strengthen public nature of medical sector'
- by Lee, Jeong-Hwan Jun 5, 2025 06:10am
- With the election of President Lee Jae-Myung, the legal community predicts that the government will strengthen its public policy in the healthcare and pharmaceutical biotechnology sectors. The areas of AI-based digital healthcare industry, rare and intractable disease coverage, and regional essential medical infrastructure will see new op
- Policy
- Lee Jae-Myung elected as president of South Korea
- by Lee, Jeong-Hwan Jun 5, 2025 06:10am
- With the election of Lee Jae-myung of the Democratic Party (Candidate No. 1) as the 21st President of South Korea, momentum is expected to build for key healthcare policies. These include the establishment of a National Medical Reform Public Opinion Committee to resolve conflicts between the medical community and the government, the promotion
- Policy
- Premium pricing for 11 linagliptin products ends on the 9th
- by Lee, Tak-Sun Jun 4, 2025 06:19am
- As one year has passed since the entry of generic versions of the DPP-4 inhibitor diabetes treatment Trajenta (linagliptin), the price ceiling of 11 products that received pricing premiums will be adjusted on the 9th. Three products that entered the market in March following the expiration of the first generic exclusivity period will also
