- Policy
- The benefit discussion for Steglatro was excluded
- by Lee, Tak-Sun Jun 22, 2022 05:58am
- While the HIRA is discussing the standard for combination therapy benefits for SGLT-2-suppressing diabetes treatments, only Steglatro (MSD Korea) has been excluded from the combination of TZD affiliates, drawing attention. While the combination of DPP-4 inhibitors between families is recognized, the combination between TZD families is differenti
- Policy
- Report of severe skin SE such as rash of Phenytoin
- by Lee, Hye-Kyung Jun 21, 2022 05:55am
- Precautions for severe skin abnormalities will be newly established in the anticonvulsant Phenytoin. The Drug Safety Evaluation Division of the MFDS has prepared a change (proposal) in domestic drug permits based on the results of the EMA's review of drug safety information. The changes will be checked by the pharmaceutical industry and
- Policy
- The HIRA launched a benefit review for Tabrecta
- by Lee, Tak-Sun Jun 21, 2022 05:54am
- There are not many patients with MET mutation, but the prognosis is bad, so a treatment is urgently needed. It was found that the HIRA began a benefit review for targeted treatments for MET mutants, which appear in 3-4% of all non-small cell lung cancer patients. The MET mutation target anticancer drug landed in Korea in November last year
- Policy
- Drug price cut refund bill’s fate depends on LJC Chair
- by Lee, Jeong-Hwan Jun 20, 2022 06:04am
- Industry expectations are rising on the prospect that the constitution of the NA leadership in the second half of the year will directly affect the fate of the Bill to recover and retrieve drug price cuts. If the People Power Party, which had been criticizing the inadequacy of the bill, takes Chair of the Legislation and Judiciary committe
- Policy
- Hanmi obtains generic exclusivity for Dapalon Duo
- by Lee, Hye-Kyung Jun 20, 2022 06:03am
- Hanmi Pharmaceutical obtained generic exclusivity rights for its SGLT-2 antidiabetic combination drug ‘Dapalon Duo SR Tab (Dapagliflozin Bis L-proline/ Metformin Hydrochloride),’ a generic version of ‘Xiguo XR Tab (Dapagliflozin Propanediol Hydrate/ Metformin Hydrochloride). The Ministry of Food and Safety recently granted marketing a
- Policy
- BA-linked listed drugs are about to be re-evaluated
- by Lee, Tak-Sun Jun 20, 2022 06:03am
- Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance. The MOHW announced that it would directly con
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 20, 2022 06:02am
- The MFDS (Director Oh Yoo-kyung) announced on the 15th that it will change the efficacy, and indication precautions of "JAK Inhibitor", which is used as a treatment for inflammatory diseases. Patients can be used the same as before, but high-risk patients such as those aged 65 or older, high-risk cardiovascular groups, and risk of malignancy
- Policy
- The KDCA is pushing for the introduction of Tecovirimat
- by Lee, Jeong-Hwan Jun 20, 2022 06:02am
- The KDCA announced on the 14th that it will hold a joint meeting of related ministries to introduce 500 people of the antiviral drug Tecovirimat in July to respond to monkeypox. Kwon Joon-wook, head of the National Institute of Health, made this announcement at a briefing on COVID-19. The KDCA plans to hold a meeting of the monkeypox task
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 16, 2022 05:58am
- It was confirmed that the opinions of the Central Pharmaceutical Affairs Council members were also mixed over the limited use of Janus kinase Inhibitors, which is used as a treatment for inflammatory diseases. The MFDS announced on the 15th that high-risk patients aged 65 or older, high-risk cardiovascular groups, and malignant tumors will be
- Policy
- Listing period for new drugs to be reduced up to 60 days
- by Kim, Jung-Ju Jun 16, 2022 05:57am
- The government will reduce the new drug reimbursement listing procedures by up to 60 days to reinforce accessibility to new drugs. Also, the government plans to expand pharmacoeconomic evaluation (PE) exemptions, a mechanism that plays a key role in the deliberations made on the reimbursement adequacy of new drugs. This is a specified pla
