- Policy
- A bill to revise some of the Jeju Special Law
- by Lee, Jeong-Hwan Sep 9, 2021 05:55am
- The bill banning the opening of for-profit hospitals and pharmacies in Jeju is aimed at preventing controversy over the Greenland International Medical Center by deleting special provisions on the opening of foreign medical institutions and foreign-only pharmacies. The plan aims to eliminate controversy that could cause confusion in the do
- Policy
- Proposal of a bill to abolish special cases for Jeju
- by Lee, Jeong-Hwan Sep 8, 2021 06:05am
- A bill has been proposed by the National Assembly to abolish special cases for the opening of Jeju for-profit hospitals. The move is aimed at resolving the controversy over the establishment of for-profit hospitals by deleting special cases for opening foreign medical institutions. On the 7th, Representative Wi Sung-gon of Democratic Party
- Policy
- 3 companies voluntarily recall varenicline products
- by Lee, Jeong-Hwan Sep 8, 2021 06:05am
- Results of the safety investigation conducted by the Ministry of Food and Drug Safety on the N-nitroso-varenicline (NNV) impurity that was found in the smoking-cessation aid varenicline showed that the impurity’s risk of harming the human body was very low. However, all drugs that contain over ‘733ng (nanograms)/day’ of NNV will be
- Policy
- GSK's Shingrix has been granted
- by Lee, Tak-Sun Sep 8, 2021 06:05am
- GSK's shingles virus vaccine has been approved in Korea. As a result, competition between MSD and SK Bioscience is expected to take place for the lead in the market. The MFDS approved GSK's gene recombinant shingles vaccine Shingrix on the 6th. This product is a vaccine used to prevent shingles in adults over the age of 50 and those who a
- Policy
- Roche’s Herceptin+Perjeta combo is approved in Korea
- by Lee, Tak-Sun Sep 7, 2021 05:53am
- Roche’s developed a fixed-dose combination using two of its breast cancer treatments, Herceptin (trastuzumab) and Perjeta (pertuzumab). The Ministry of Food and Drug Safety approved Roche Korea’s ‘Phesgo (trastuzumab/pertuzumab) on the 6th. Trastuzumab and pertuzumab are commonly used ingredients for breast cancer. The original bra
- Policy
- The request for Zolgensma's benefit is growing
- by Lee, Jeong-Hwan Sep 7, 2021 05:53am
- Although only one intravenous administration has proven to be nearly cured of spinal muscular dystrophy (SMA), the administration costs about &8361;2.5 billion, increasing the demand for insurance benefits for Zolgensma (Onasemnogene Abeparvovec), which is called an "extremely high-priced one-shot treatment. Following the U.S. and Japan,
- Policy
- Letrozole for ovulation-inducing use is not allowed
- by Lee, Hye-Kyung Sep 7, 2021 05:53am
- An application to use Letrozole (Bretra, Femara, Letrozole) as non-reimbursment has been rejected. The HIRA is receiving applications in advance for the use of non-reimbursement from the MFDS to prevent the use of drugs that lack medical grounds or are concerned about safety. According to The HIRA's recent details of "disapproval of use fo
- Policy
- Insurance benefit denied for 3 Soliris and 1 Ultomiris cases
- by Lee, Hye-Kyung Sep 6, 2021 05:58am
- Last month, ‘Soliris (eculizumab)’ and ‘Ultromiris (ravulizumab),’ which both require prior approval to be administered with reimbursement, saw mixed results in the rate of approval of their preliminary applications. In July, the Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee deliberated reimb
- Policy
- JAK Inhibitors increases heart attack
- by Lee, Tak-Sun Sep 6, 2021 05:58am
- The health authorities warned that taking JAK inhibitors, which are used as a treatment for rheumatoid arthritis, could cause serious heart problems such as heart attacks. The target items are Tofacitinib, Baricitinib, and Upadacitinib, which have been actively used in the market recently, so medical professionals will need to examine them mo
- Policy
- The Committee discusses the permission for Mifegymiso
- by Lee, Tak-Sun Sep 5, 2021 08:25pm
- Mifegymiso, which Hyundai has applied for permission, will be discussed at the Central Pharmaceutical Advisory Committee, the MFDS' legal advisory body. The Central Pharmaceutical Advisory Committee's consultation is expected to determine whether Mifegymiso will conduct a bridging study in Korea. The MFDS will hold a meeting at the Cen
