- Policy
- “Mooncare a success…37 million people saved ₩9 tril.
- by Lee, Jeong-Hwan Aug 13, 2021 05:57am
- President Moon Jae-in said the government will continue and accelerate its efforts to further broaden the NHI coverage in 2022 as in this year. Moon also stated that 37 million people in Korea were able to save a total of 9.2 trillion won in medical costs during the 4 years since Mooncare was implemented. Also, he personally announced
- Policy
- Regkirona's indication expansion has been requested
- by Lee, Tak-Sun Aug 13, 2021 05:57am
- Celltrion's COVID-19 antibody therapy Regkirona is pushing for an expansion of indications based on global phase 3. Regkirona was conditionally approved to submit a clinical trial result report for therapeutic confirmation in February and was used only in patients with mild to secondary COVID groups. Celltrion submitted a report on the result
- Company
- SGLT-2 inhibitor Forxiga lands in Korea with CKD indication
- by Eo, Yun-Ho Aug 12, 2021 06:05am
- An SLGT-2 inhibitor is soon expected to be available for use in chronic kidney disease (CKD) patients in Korea. According to industry sources, the indication of AstraZeneca’s diabetes treatment ‘Forxiga(dapagliflozin)’ will be expanded to ‘the treatment of chronic kidney disease in patients at risk of progression with and without type
- Policy
- With Ultomiris, 9 items require prior approval for reimb.
- by Lee, Hye-Kyung Aug 12, 2021 06:05am
- Improvements are expected to be made to the ‘pre-approval' system that may be actively used in the process of reimbursement listings for ultra-high-priced drugs. Starting with the stem cell transplantation procedure in 1992, the Health Insurance Review and Assessment Service (HIRA) has been operating the pre-approval system to deliberate in
- Policy
- A review of Hemlibra's benefit without ITI is under way
- by Lee, Hye-Kyung Aug 12, 2021 06:05am
- The HIRA is reviewing the benefit criteria for JW Pharma's hemophiliac injection Hemlibra (Emicizumab). Currently, patients aged 1 and older and under 12 years of age may be re-administered if they fail the Immune Tolerance Induction (ITI) or if they meet the ITI target criteria (Trial 2020-164, 2020. 6.1.), or if they are unable to try,
- Policy
- President called for stronger health insurance coverage
- by Kang, Shin-Kook Aug 12, 2021 06:04am
- President Moon called Yong-Ik Kim, President of NHIS and Sun-min Kim, Executive Director of the HIRA to discuss the results of measures to strengthen health insurance coverage and supplement the people's benefits at meeting with his senior secretaries on the 9th. President Moon ordered, "In case of not receiving medical benefits due to c
- Company
- Eybelis can be prescribed at general hospitals
- by Eo, Yun-Ho Aug 11, 2021 05:58am
- The new glaucoma treatment ‘Eybelis’ that has been released can now be prescribed at general hospitals in Korea. According to industry sources, Santen Pharmaceutical Korea’s selective EP2 receptor Eybelis Ophthalmic Solution (Omidenepag Isopropyl) has recently passed the review of drug committees (DC) in two of the ‘Big 5’ major hospi
- Policy
- # of subjects in Phase 3 of SK's COVID vaccine is 93
- by Lee, Tak-Sun Aug 11, 2021 05:58am
- When looking at SK Bioscience's clinical plan for "GBP510," which entered phase 3 for the first time as a vaccine developed in Korea, the number of people tested in Korea was 93. This is only 2.3% of 3,990. The MFDS recommends that domestic test subjects recruit more than 10% of the total subjects for domestic development vaccines, which i
- Company
- Changes after Pfizer and Moderna vaccines' full approval
- by Aug 11, 2021 05:58am
- Expectations are rising that COVID-19 vaccines of multinational pharmaceutical companies such as Pfizer-BioNTech and Moderna will receive full regulatory approval early next month. If the vaccines are formally approved, what changes will we see in the current landscape where people worldwide are already receiving vaccinations under the EUA?
- Policy
- South Korea recovered Sartan products with AZBT impurities
- by Lee, Tak-Sun Aug 11, 2021 05:58am
- The recovery of Sartan medicines containing 'AZBT' has also begun in Korea. Three products containing Irbesartan, manufactured in 2021, were voluntarily recovered by related pharmaceutical companies. Starting in Canada in May, recovery of Sartan containing AZBT is spreading around the world to Europe and Asia. The MFDS announced on the 6th
