- Policy
- Conditional approval on Celltrion COVID-19 treatment advised
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The South Korean health authority’s panel of experts verified the clinical results and advised an approval of Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona with a condition to conduct Phase III trial. The panel recommended the drug to be used to alleviate the mild to moderate COVID-19 symptoms in adult patients.
- Policy
- Yuhan's Lazertinib was approved
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The new drug Lazertinib developed by Yuhan for the treatment of non-small cell lung cancer has obtained approval from the MFDS. The technology was transferred to the global pharmaceutical company Janssen and is currently undergoing licensing procedures in other countries such as the United States. It is the first country in the world to obtai
- Policy
- COVID-19 vaccination to start in February
- by Lee, Jeong-Hwan Jan 20, 2021 06:01am
- “COVID-19 vaccination begins at the end of February and early March, and will form herd immunity in November at the latest. If side effects occur only after the vaccination, the government will be fully responsible. I am urged to inoculate, and if the national anxiety increases and the need to take an initiative, as the president, I will not
- Policy
- NMO drugs ready for Korean market release within this year
- by Lee, Tak-Sun Jan 19, 2021 06:02am
- A group of rare disease neuromyelitis optica (NMO) treatments are preparing for the South Korean market. NMO is a chronic disease with a no specific treatment. Recently, however, a number of treatments for the disease have passed the U.S. Food and Drug Administration (FDA) and they are now readying for the South Korean health authority’
- Policy
- 68% to “wait and see” before COVID-19 vaccination
- by Jan 18, 2021 06:14am
- Apparently, six out of 10 people in South Korea are intending to ‘get inoculated after confirming the outcome’ of the COVID-19 vaccine. Only 28.6 percent answered they would ‘get inoculated as soon as possible.’ As requested by a public survey research firm KSTAT Research, Professor You Myung Soon at Seoul National University Grad
- Policy
- Celltrion announced results of external clinical trials
- by Lee, Tak-Sun Jan 18, 2021 06:13am
- The MFDS will hold a verification advisory group meeting on the 17th to evaluate the appropriateness of the clinical trial results for COVID-19 treatment Rekirona developed by Celltrion. And it plans to announce the results on the 18th. After the verification advisory group meeting, the Central Pharmaceutical Affairs Review Committee and t
- Policy
- Will COVID-19 vaccine by SK be released first?
- by Lee, Tak-Sun Jan 15, 2021 06:11am
- Among AstraZeneca's COVID-19 vaccines that have been applied for approval from the MFDS, it is highly likely that the vaccine that SK Bioscience is consigning and producing will be distributed for the first time in Korea. Recently, the MFDS has reported that item approval and lot release can be reviewed in duplicate to speed up the market
- Policy
- Tamiflu for oral suspension has withdrawn
- by Lee, Tak-Sun Jan 15, 2021 06:10am
- Roche's original influenza treatment Tamiflu for oral suspension is withdrawn from the domestic market due to the expiration of the product license. Generics for Tamiflu for oral suspension occupied in advance. As of the 13th, the MFDS withdrew Tamiflu for oral suspension 6mg/ml (Oseltamivir) from Roche Korea due to the expiration of the p
- Policy
- Indications for Forxiga include CHF
- by Kim, Jung-Ju Jan 15, 2021 06:10am
- As the indication for AstraZeneca’s SGLT-2 inhibitor Forxiga 10mg (Dapagliflozin) has been extended to chronic heart failure, it is clearly covered in the benefit. On the 12th, the MOHW announced a partial amendment to the 'Pharmaceutical Reimbursement Listing Standard and Method', which establishes the reimbursement standards for additio
- Policy
- COVID-19 vaccine budget KRW 857.1 Bln received
- by Kim, Jung-Ju Jan 14, 2021 06:15am
- The South Korean health authority is fully readying for COVID-19 vaccination starting off from February as they have first secured the budget for the vaccine purchase and expenditure for inoculation. The Korea Disease Control and Prevention Agency (KDCA) announced on Jan. 12 the vaccine purchasing budget and inoculation expense budget of
