- Policy
- HIRA plans to improve the overall management system
- by Lee, Tak-Sun May 20, 2022 06:11am
- With the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system. Accordingly, it has been confirmed that internal research is being carried out. The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system. However
- Policy
- 34 new global drugs, including Beleodaq, are urgently needed
- by Lee, Tak-Sun May 18, 2022 05:52am
- A study has been released that 34 new drugs, including the peripheral T-cell lymphoma treatment Beleodaq, are urgently needed to be introduced in Korea. These new drugs have not been introduced because they are judged to be insufficient in marketability due to domestic screening permits. KoNECT announced that it will select 34 new drugs th
- Policy
- MFDS promotes RWD analysis of COVID-19 vaccines & txs
- by Lee, Hye-Kyung May 18, 2022 05:51am
- The MFDS (Director Kim Kang-rip) will push for a benefit and risk assessment study from May this year based on data actually used in medical sites after the COVID-19 vaccine and PO treatment were introduced in Korea. This study was prepared to analyze safety information such as the incidence of side effects, vaccine defense effects, and hospi
- Policy
- Discussions on the benefits of migraine txs begin in earnest
- by Lee, Tak-Sun May 16, 2022 06:14am
- As Lilly Korea's Emgality passed the HIRA's Drug Reimbursment Evaluation Committee, discussions on the benefit of the migraine txs are rapidly progressing. Following Emgality, Handok Teva's Ajovy, the same (CGRP) target treatment, is also seeking to enter the benefit. Reyvow of Ildong Pharmaceutical, which was approved in Korea on the 12th
- Policy
- Daewoong’s P-CAB drug Fexclu receives conditional approval
- by Lee, Tak-Sun May 16, 2022 06:14am
- Daewoong Pharmaceutical’s P-CAB class gastroesophageal reflux disease (GERD) treatment ‘Fexclu’ has received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. The committee decided reimbursement was appropriate for the drugs if the company accepts a price below the apprais
- Policy
- MOHW holds a launching meeting of the pharmaceutical team
- by Kim, Jung-Ju May 13, 2022 05:46am
- The MOHW (Minister Kwon Deok-cheol) announced at 3 p.m. on the 12th that it will hold a launching meeting of the mid- to long-term strategic planning team for the pharmaceutical industry to establish the "third comprehensive plan for fostering and supporting the pharmaceutical industry." The government shall prepare a five-year comprehensive
- Policy
- Vaccine consultative body launched
- by Kim, Jung-Ju May 13, 2022 05:45am
- Representative vaccine companies in Korea will launch a "Vaccine consultative body" to establish vaccine sovereignty and enhance international competitiveness, and actively cooperate with the aim of strengthening R&D capabilities in the industry and promoting vaccine commercialization. The MOHW (Minister Kwon Deok-cheol) and the Vaccine Pr
- Policy
- Will Ho-Young Chung be able to enter Cabinet?
- by Lee, Jeong-Hwan May 12, 2022 06:07am
- With the inauguration of the new administration on the 10th, whether the Health and Welfare Minister nominee Ho-Young Chung will be able to enter President Yoon’s Cabinet is now at a crossroads. Industry experts expect that the nominee will be appointed today (12th) after the Minister of Economy and Finance Choo Kyung-ho starts his role
- Policy
- Evusheld will be included in Govnt's supplementary budget
- by Lee, Jeong-Hwan May 12, 2022 06:06am
- The government is setting out to secure a supplementary budget for the introduction of ‘Evusheld (tixagevimab, cilgavimab),’ an antibody combination treatment used to prevent COVID-19 infection in the immunocompromised that see a low effect from vaccinations. With the National Assembly also agreeing on the need to introduce Evusheld, it
- Policy
- “Dualized RWD collection for Kymriah is inefficient”
- by Lee, Tak-Sun May 11, 2022 05:55am
- With the registration of the ultra-expensive one-shot treatment Kymriah, the opinion was raised that a plan should be prepared to ensure the efficiency of the system by standardizing the dualized real clinical data (RWD) collection required by different institutions. That the separate collection of data by the Ministry of Food and Drug S
