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2022-07-03 22:54
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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
Policy
Phase 2 of Shinpoong's Pyramax will be conducted again
by
Lee, Hye-Kyung
Jun 16, 2022 05:57am
Shinpoong will conduct phase 2 clinical trials of Pyramax again to prove its safety and effectiveness as a treatment for COVID-19. On the 13th, the MFDS approved a clinical trial to explore the safety and effectiveness of Pyramax in patients with mild or moderate COVID-19. Exploratory clinical trials are clinical trials conducted for the p
Policy
HIRA to review metformin+SGLT2+DPP4 reimb at last
by
Lee, Tak-Sun
Jun 15, 2022 05:51am
The Health Insurance Review and Assessment Service entered the final steps of its reimbursement review for a 3-drug combination therapy that contains metformin, an SLGT-2 inhibitor, and a DPP-4 inhibitor. Reimbursement of the combined use of SGLT-2 and DPP-4 class oral antidiabetic drugs had been continuously raised as an issue by academ
Policy
Policies at a standstill due to absence of MFDS minister
by
Lee, Jeong-Hwan
Jun 15, 2022 05:50am
With the ruling and opposition parties having difficulty coming to an agreement on the composition of the NA leadership, the prolonged policy gap in national disease control and prevention and the pharma-bio industry is intensifying due to the absence of the Minister of Health and Welfare. President Suk-Yeol Yoon¡¯s administration had set
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