- Policy
- MFDS-EMA, temporary confidentiality agreement for COVID-19
- by Lee, Jeong-Hwan Jul 2, 2020 06:08am
- The MFDS announced on the 30th that it had temporarily signed a confidentiality agreement with the European Medicines Agency (EMA) when exchanging information for the diagnosis, prevention and treatment of related infectious diseases including COVID-19. This agreement has the significance of establishing a close information exchange system
- Policy
- Pharmaceutical coverage list updated with Xolair and Akave
- by Kim, Jung-Ju Jul 2, 2020 06:08am
- As an allergic asthma treatment Xolair injection (omalizumab) was newly listed, the detailed criteria for healthcare reimbursement was also updated. Also the reimbursement standard on hypertension and hyperlipidemia combination drug added new ‘fimasartan plus atorvastatin’ combination due to the new listing of Akave tablet. Korea’
- Policy
- α-GPC can be adjusted in advance up on to clinical plan
- by Lee, Tak-Sun Jul 1, 2020 05:56am
- The MFDS announced its position for the first time in the clinical re-evaluation of 'Choline alfoscerate', a brain function improving agent. The MFDS said there were no procedural issues related to this evaluation, and the duration or number of tasks will be decided after the clinical plan is received. However, it emphasized that approval
- Policy
- MFDS lifts nizatidine sales ban, Alvogen cancels license
- by Lee, Tak-Sun Jul 1, 2020 05:54am
- Alvogen Korea has reportedly cancelled the item license on its nizatidine drug, although its sales ban for containing the unacceptable level of cancerous NDMA was listed. The case proves lifting the sales ban and a company’s will to sell the product are two different matters. On June 25, Korea’s Ministry of Health and Welfare (MOHW
- Policy
- Korea Passing Novartis Xolair listed for reimbursement
- by Kim, Jung-Ju Jun 30, 2020 06:10am
- The Korean health authority has decided to grant healthcare benefit from next month on Xolair (omalizumab), the controversial ‘Korea Passing’ drug that withdrew the reimbursement application amid the pricing negotiation to avoid lowering the global price, from next month. The listing of the novel severe asthma treatment Xolair took t
- Policy
- “KRW 10 bln COVID-19 vaccine budget plan unclear and vague"
- by Lee, Jeong-Hwan Jun 30, 2020 06:09am
- The voice of criticism is raised against weak and vague ‘budget plan on COVID-19 treatment and vaccine manufacturing facility establishment support (R&D)’ worth 10 billion won the Korean government included as a part of the third contingency budget plan. They point out a detailed business plan has to be set down first as the budget can be
- Policy
- Insurance benefits of Dupixent PFS 300mg will be possible
- by Lee, Hye-Kyung Jun 30, 2020 06:08am
- After the approval of the MFDS on April 1, insurance benefits of 'Dupixent PFS 300mg (dupilumab)' will be possible when the adolescent patients are over 18 years old. As a patient with chronic severe atopic dermatitis who is over 18 years of age and has symptoms that persist for more than 3 years, ▲ it is not adequately regulated even
- Policy
- α-GPC clinical reevaluation requires ₩50 billion
- by Lee, Tak-Sun Jun 29, 2020 06:13am
- The industry estimates the cost of clinical re-evaluation of the brain function improving agent 'Choline alfoscerate' to &8361;50 billion. This is the amount calculated when conducting clinical trials for all licensed indications. As the amount is large, the cost per company will be determined according to the number of companies participati
- Policy
- SNUH started a clinical trial of Remdesivir+Baricitinib
- by Lee, Jeong-Hwan Jun 29, 2020 06:12am
- Seoul National University Hospital announced on the 25th that it will be conducting a follow-up clinical trial of Remdesivir, which has proven effective as a treatment for COVID-19. This is a clinical trial that seeks drug efficacy and safety when Remdesivir is administered alone or when Baricitinib & Remdesivir are administered. Seou
- Policy
- Boryung's Akave will be newly listed
- by Kim, Jung-Ju Jun 26, 2020 06:42am
- Boryung's Akave 30/10mg will be newly listed next month. This drug is a combination of Fimasartan and Atorvastatin. Guerbet Korea's 14 listed pharmaceutical products, such as Lipiodol ultra liquid (Iodized oil), have a lower price. The MOHW confirmed and revised the list of drug benefits and the upper limit. It will take effect from July 1st.
