- Policy
- How Tenelia latecomers lost chances in preferential sales
- by Lee, Tak-Sun Sep 8, 2020 06:11am
- Although Kyungdong Pharmaceutical first received approval on antidiabetic Tenelia’s incrementally modified drug (IMD), the drug is apparently not eligible for the preferential sales right given to the generic market. Regardless of the preferential right, any Tanelia IMDs that successfully evaded the original’s salt base patent can be l
- Policy
- NA burdened as dispute continues despite Gov-KMA agreement
- by Lee, Jeong-Hwan Sep 8, 2020 06:11am
- As the dispute among medical community is deepening regardless of South Korea’s Ministry of Health and Welfare (MOHW) and Korean Medical Association (KMA) settling on an agreement, the National Assembly is now burdened with a grave responsibility to deliver the agreed terms and to fairly execute the medical reform plan. The Young Doct
- Policy
- There is no disadvantage in the long-term Rx due to COVID-19
- by Lee, Hye-Kyung Sep 8, 2020 06:11am
- It has been emphasized once again that there are no disadvantages for appropriate long-term prescriptions within the scope of medically recognized health authorities. It has been clarified that it will not cut down on necessary and appropriate long-term prescriptions so that medical institutions can actively respond to medical gaps due to doc
- Policy
- SCD's Eylea biosimilar was approved for phase III trials
- by Lee, Tak-Sun Sep 7, 2020 06:12am
- SCD Pharm has been approved for a phase III clinical trial of a biosimilar for Eylea (Aflibercept, Bayer), a macular degeneration treatment for the third time in Korea. In June, it was approved for the third phase III clinical trial following Samsung Bioepis and Amgen. It is noted who will succeed in commercialization first in Korea. On th
- Policy
- The MFDS supports ₩25.6 billion for COVID-19
- by Lee, Tak-Sun Sep 4, 2020 06:53am
- The MFDS has established a budget of &8361;25.6 billion next year to support the commercialization of COVID-19 vaccines and K-quarantine products. The MFDS announced on the 2nd that the government budget for 2021 has increased by &8361;45.2 billion (8.1%) from &8361;559.2 billion this year to a total of &8361;604.4 billion. The budget
- Policy
- DREC and Cancer Committee to convene more on-paper meetings
- by Lee, Hye-Kyung Sep 3, 2020 06:29am
- The South Korean government is to alleviate on-paper deliberations related regulation for the first threshold of pharmaceutical reimbursement listing&8212;the Drug Reimbursement Evaluation Committee (DREC) and Cancer Deliberation Committee. The Health Insurance Review and Assessment Service (HIRA) preannounced partially revised manageri
- Policy
- Celltrion's COVID-19 antibody treatment phase I completed
- by Lee, Tak-Sun Sep 3, 2020 06:27am
- The MFDS announced on the 1st that the COVID-19 antibody treatment drug Celltrion is developing has completed phase I clinical administration and is currently under review of phase II/III trial plans. The MFDS announced the progress of the COVID-19 treatment and vaccine clinical trials in the explanatory data. Celltrion's new drug (CT-P59)
- Policy
- IND for AK-216 (Vildagliptin) by Alvogen Korea was approved
- by Lee, Tak-Sun Sep 3, 2020 06:27am
- Alvogen Korea is launching a phase III clinical trial of Vildagliptin, a diabetes treatment of DPP-4 inhibition. It is entering phase III in 9 months after approval of clinical trial I in November of last year. However, the effectiveness with Metformin, not monotherapy, are verified. While generics for Galvus are aiming for an early release
- Policy
- 2021 MOHW budget KRW 90.15 tln--KRW 131 bln on COVID-19
- by Kim, Jung-Ju Sep 3, 2020 06:27am
- South Korea’s Ministry of Health and Welfare (MOHW) has finalized next year’s budget plan with 90 trillion won. The state funding for National Health Insurance (NHI) has been raised to 9.5 trillion won. 131.4 billion won was allocated on providing support on R&D seeking COVID-19 treatment and vaccine. Moreover, the state-led new drug R&D p
- Policy
- HIRA clears all Strensiq pre-approvals from July
- by Lee, Hye-Kyung Sep 2, 2020 06:18am
- Handok’s rare disease treatment Strensiq injection (asfotase alfa) passed the preliminary approval review and processed the first reimbursed administration. Listed for healthcare reimbursement as of June 1, Strensiq is a third drug to be required to receive pre-administration approval for a reimbursed use of the drug. Soliris injection (ecu
