- Policy
- KDCA “All hands on deck to seek COVID-19 vaccine"
- by Kim, Jung-Ju Sep 16, 2020 06:25am
- The first director of Korea Disease Control and Prevention Agency (KDCA) Jeong Eun-kyeong stated the government agency would provide all possible support for seeking vaccine and treatment to completely overcome the COVID-19 crisis. Also, she added the rare disease designation and R&D for disease testing and treatment would be expanded as
- Policy
- Crovalimab by Roche is conducting phase III in Korea
- by Lee, Tak-Sun Sep 15, 2020 06:27am
- Soliris (Eculizumab), which has recorded high sales as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare disease, is undergoing phase III clinical trial in Korea. It is Crovalimab, excavated by Chugai in Japan and developed by Roche. On the 11th, the MFDS approved a phase III IND for 'RO7112689' submitted by IQVIA Korea. RO
- Policy
- Famvir licensed by Ildong is now manufactured locally
- by Lee, Tak-Sun Sep 15, 2020 06:26am
- Ildong Pharmaceutical is anticipating Famvir profit to improve as the drug licensed out by Novartis would be manufactured in South Korea. A shingles treatment Famvir is an original famciclovir drug that Novartis received approval to market in South Korea in year 2002. In 2018, Ildong Pharmaceutical acquired the sales rights over Famv
- Policy
- New osteoporosis drug Evenity passed deliberation
- by Lee, Hye-Kyung Sep 15, 2020 06:26am
- Amgen Korea's bone formation promoting and bone resorption inhibitor Evenity PFS (Romosozumab) passed the deliberation. On the 11th, the HIRA (President, Sun Min Kim) released the results of the deliberation on the adequacy of medical benefits for the drugs applied for decision deliberated by the '9th Pharmaceutical Benefits Advisory Comm
- Policy
- Fluarix Tetra, full-scale competition for flu vaccines
- by Lee, Tak-Sun Sep 14, 2020 06:15am
- The quadrivalent flu vaccine 'Fluarix Tetra', which was first introduced in Korea in 2015, was approved by the Ministry of Food and Drug Safety, and began to compete in the market in earnest. GSK's Fluarix Tetra is a representative imported vaccine that has been ranked at the top since its launch in 2015. However, it is expected to act as
- Policy
- GSK withdraws adult TD vaccine from Korea
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- GSK will stop supplying the adult TD vaccine 'Td-pur', which was imported and sold in Korea. The company said there was no additional import after November 30. Until now, adult TD vaccines have been dependent on imports, but GC Pharma succeeded in localizing them in 2016. With GSK's supply discontinuation of Td-pur, the localization of GC
- Policy
- First drug for ultra rare Batten disease Brineura approved
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- The first treatment for a pediatric rare disease, Batten disease, has received the South Korean health authority’s approval. As Batten disease is an inherited metabolic disorder that can cause loss of sight, the new treatment could give hopes to the patients and their families. Ministry of Food and Drug Safety (MFDS) has approved Brineura 1
- Policy
- The MOHW’s new budget focuses on new drugs·COVID-19 trial
- by Lee, Jeong-Hwan Sep 10, 2020 06:23am
- While the budget plan of the MOHW for 2021 was released, it was found that the new budget focused on the treatment field, such as the national new drug development project and non-clinical support for COVID-19 treatment and vaccine. The new budget for the national new drug development project was ￦150.5 billion, and the new budget for non
- Policy
- MFDS to shorten fast-track review by a month
- by Lee, Tak-Sun Sep 10, 2020 06:23am
- With the latest reorganization effective from Aug. 31, South Korea’s Ministry of Food and Drug Safety (MFDS) has formed ‘Fast-track Review Division’ and ‘Preliminary Consulting Division’ under National Institute of Food and Drug Safety Evaluation (NIFDS) to expedite the review process on innovative new drugs. The pharmaceutical indu
- Policy
- Kang Do-tae & Jeong Eun-Kyeong were promoted
- by Kim, Jung-Ju Sep 9, 2020 05:49am
- Kang Do-tae, the current head of the Planning and Coordination Office (51, Seoul National University, Master of Public Administration), was appointed as the first multiple vice minister to lead the health sector of the Ministry of Health and Welfare. The next Vice Minister, Kang Do-tae, the first multiple Vice Minister of the MOHW, is in c
