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2024-10-22 10:17
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Policy
Dongkook receives reimb for s-amlodipine triple-drug combo
by
Lee, Tak-Sun
Oct 22, 2024 05:52am
Dongkook Pharmaceutical has succeeded in becoming the first Korean company to receive reimbursement for a three-drug combination drug for hypertension that combines the CCB ¡®s-amlodipine,¡¯ ARB ¡®olmesartan¡¯ and diuretic ¡®hydrochlorothiazide¡¯. The combination therapy is expected to be useful for patients whose blood pressure is not ad
Policy
MFDS grants EUA to COVID-19 variant vaccine for infants
by
Lee, Hye-Kyung
Oct 22, 2024 05:51am
The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 21st that it has granted Emergency Use Authorization for 'Comirnaty JN.1 Inj 0.033 mg/mL (bretovameran),' a SARS-coV variant (JN.1) vaccine for infants aged 6 months-4 years. Emergency Use Authorization is a system designed to respond appropriately to
Policy
2nd GIFT drug Nefecon¡¯s approval imminent in Korea
by
Lee, Hye-Kyung
Oct 21, 2024 05:48am
Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug last year, is close to receiving approval in Korea. According to industry sources on the 21st, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Nefecon. The completion of the safety
Policy
How to stabilize supply of national essential medicines
by
Lee, Hye-Kyung
Oct 18, 2024 05:49am
While prescribing drugs by ingredient name and introducing international nonproprietary names (INNs) are being discussed as measures to stabilize the supply of drugs, voices have emerged calling for a system that allows the use of the same ingredient drugs as nationally essential medicines. The issue of stabilizing the supply of not only
Policy
'Can the Yoon administration develop blockbuster drugs?'
by
Lee, Jeong-Hwan
Oct 18, 2024 05:49am
Criticism has been raised that the government's policy to create global blockbuster drugs is not working and has a dark future. It has been pointed out that the difficulty in raising funds to support the R&D costs for pharmaceutical and biotech companies and ventures is causing financial difficulties for bioventures, and that expert hu
Policy
Gov't opposes to suspending reimb¡¤ingredient prescribing
by
Lee, Jeong-Hwan
Oct 17, 2024 05:52am
The government has opposed the proposed measure, which aims to minimize the chaos in prescription¡¤dispensing by suspending insurance reimbursement or blocking prescription code of drugs when substitute drugs are available. Suspending reimbursement of drugs covered by insurance is a temporary measure implemented in the case of administr
Policy
HIRA President, "Copayment ratio needs to be adjusted
by
Lee, Tak-Sun
Oct 17, 2024 05:51am
HIRA President Jung-Gu Kang said that the copayment ratio should be adjusted for anticancer drugs that lack verification of effectiveness. Kang said during the parliamentary audit by the Health and Welfare Committee, "We must lower the patient access hurdle and increase monitoring." Adding, "Especially because we evaluate high-cost drugs
Policy
Alvogen receives approval for its Humira biosimilar in KOR
by
Lee, Hye-Kyung
Oct 17, 2024 05:51am
A fifth Humira biosimilar has been approved in Korea. On the 15th, the Ministry of Food and Drug Safety approved Alvogen Korea's Simlandi pen40mg/0.4mL (adalimumab, recombinant), Simandi Prefilled Syringe Inj 40mg/0.4mL and 80mg/0.8mL.. Simlandi is imported and manufactured on consignment by Alvotech, a subsidiary of Alvogen Korea.
Policy
¡®Will raise ICER threshold for innovative new drugs¡¯
by
Lee, Jeong-Hwan
Oct 16, 2024 05:50am
The government has reaffirmed its policy to flexibly evaluate the ICER (incremental cost-effectiveness ratio) threshold for drugs that demonstrate innovativeness in order to strengthen patient access to new drugs. The intent is to increase the ICER threshold of new drugs based on previously announced criteria such as substitutability, pro
Policy
Govt ¡®is considering measures to overcome Korea Passing¡¯
by
Lee, Jeong-Hwan
Oct 16, 2024 05:50am
The government has responded that it will come up with measures to ensure a stable supply of new drugs, including a dual pricing system, to overcome the so-called ¡®Korea passing¡¯ phenomenon, in which domestic and foreign pharmaceutical companies avoid launching their drugs in the domestic market and target overseas markets first, citing ex
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