- Policy
- The approval of Atozet’s generics was also difficult
- by Lee, Tak-Sun Feb 4, 2021 06:09am
- It has become difficult for generic companies of MSD's hyperlipidemia complex Atozet to approve items in January. If the approval was obtained in January, the drug for data-based re-evaluation commissioned by Chong Kun Dang and the timing of the registration were the same, so that within 20 drugs could be applied. However, it is known that th
- Policy
- Re-evaluation of benefits, scheduled to be conducted annuall
- by Kim, Jung-Ju Feb 3, 2021 06:09am
- At the end of last year, the government is about to begin the main evaluation of the five active ingredients following the pilot project of reevaluation of the adequacy of registered drugs for Choline alfoscerate (reevaluation of the benefits of registered drugs). It seems to have taken into account the time taken for the procedure, such as revi
- Policy
- Samyang Biopharm started to develop generic for Votrient
- by Lee, Tak-Sun Feb 2, 2021 06:25am
- It was found that a domestic pharmaceutical company started developing Votrient’s generic for Novartis' blockbuster kidney cancer treatment. Generic for Votrient is attracting attention in that there are no commercialized items yet. The MFDS approved the bioequivalence test protocol of Samyang Biopharm’s SYO-1987 on the 28th of last
- Policy
- Administration of AZ vaccine to the elderly is appropriate
- by Lee, Tak-Sun Feb 2, 2021 06:25am
- The MFDS’ verification advisory group composed of domestic experts presented an opinion that there was no reason to exclude the administration of AstraZeneca's COVID-19 vaccine to the elderly. In addition, it was evaluated that the inoculation was performed twice at the standard dose, and the inoculation interval was appropriate for 4 to 12
- Policy
- Clinical data for the elderly for the AZ vaccine are lacking
- by Kim, Jung-Ju Feb 1, 2021 11:52pm
- The detailed schedule and plan for vaccination in Korea was announced, and a limited vaccination discussion continues overseas due to the lack of clinical data for AstraZeneca (AZ)'s COVID-19 vaccine, and the results of the review by licensing authorities are drawing attention later. The MFDS will take all these into account and conduct a
- Policy
- Can COVID-19 vaccine by the COVAX be quickly introduced?
- by Lee, Tak-Sun Jan 27, 2021 06:15am
- The health authorities said that it is possible to quickly introduce COVID-19 vaccine supplied from the COVAX Facility. This is because the MFDS has been participating in the COVAX Facility vaccine joint review since October at the request of the WHO. Pfizer's vaccine was pre-verified on the 31st of last month when the WHO approved Emergen
- Policy
- AZ’s Vaccine Verification Advisory Committee Meeting held
- by Lee, Tak-Sun Jan 27, 2021 02:24am
- An advisory group meeting to verify the safety and effectiveness of AstraZeneca's COVID-19 vaccine will be held on the 31st of this month. In this meeting, external experts will participate in the clinical trial data. In addition, the Central Pharmaceutical Affairs Review Committee for COVID-19 treatment developed by Celltrion will be held
- Policy
- Nexavar's price drops by 30% & Teribone inj ↑31%
- by Kim, Jung-Ju Jan 25, 2021 06:22am
- The price of Bayer Korea's anticancer drug Nexavar 200mg (Sorafenib tosylate) will be reduced by 30% next month. It is a government control. After that, at the end of the year, the benefits that have been given the premium will end and fall further. The price of Dong-A ST's postmenopausal osteoporosis treatment Teribone inj 56.5μg (teriparat
- Policy
- GemVax dementia drug candidate is reviewed for PSP
- by Lee, Tak-Sun Jan 21, 2021 06:14am
- It is considering clinical trials to verify the new drug candidate GV1001, which GemVax is developing as a treatment for Alzheimer's disease, for the rare disease progressive supranuclear pals. However, the Central Pharmaceutical Affairs Review Committee, an expert advisory body from the MFDS, has postponed the judgment that additional da
- Policy
- Paclitaxel + Carboplatin + RT will be reimbursed
- by Lee, Hye-Kyung Jan 21, 2021 06:13am
- Paclitaxel+Carboplatin+RTprior chemotherapy, which required prior approval from the Director of the HIRA, will be reimbursed for anticancer therapy The HIRA announced that it plans to announce an amendment to the announcement of drugs prescribed/administered to cancer patients containing the above contents, and that opinion inquiry will b
