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2025-10-27 10:25
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Policy
New drug Zavicefta Inj, and more completed drug pricing nego
by
Lee, Tak-Sun
Jan 23, 2024 06:02am
The two drugs Pfizer Korea¡¯s ¡®Zavicefta Inj¡¯ and ¡®Dulackhan Easy Syrup,¡¯ which were in negotiations for a drug pricing increase due to short supply, have reached agreements in negotiations with the National Health Insurance Service (NHIS), and they are expected to receive reimbursements starting next year. The chronic kidney diseas
Policy
Samsung Bioepis receives approval for its Soliris biosimilar
by
Lee, Hye-Kyung
Jan 23, 2024 06:02am
Samsung Bioepis has received approval for its Epysqli (eculizumab),¡¯ a biosimilar of the ultra-high-priced rare disease treatment Soliris (eculizumab) in Korea. At the same time, it was granted first generic exclusivity until October 19th of this year, allowing Samsung Bioepis to market its biosimilar exclusively for the next nine months
Company
SGLT2i+DPP4i combos' performance falls short of expectations
by
Kim, Jin-Gu
Jan 23, 2024 06:02am
A large number of 'SGLT-2 inhibitor (SGLT2i)+DPP-4 inhibitor (DPP4i)' combinations entered the market after Korea¡¯s insurance reimbursement was extended to cover ¡®SGLT-2 inhibitor + DPP-4 inhibitor¡¯ combinations, however, their sales performance in the first year is falling short of expectations. Of the major products that have been on
Policy
Korean patients pay ₩10.5M for ₩300M Luxturna
by
Lee, Tak-Sun
Jan 23, 2024 06:02am
Luxturna (voretigene neparvovec-rzyl, Novartis), the first gene therapy for Inherited Retinal Dystrophy (IRD), is set to be reimbursed from the 1st of next month and is expected to significantly reduce the burden of those suffering from IRD in Korea. Although the price limit for Luxturna had been set at KRW 325.8 million per vial, the out
Company
Will Verzenio secure expansion for early breast cancer?
by
Eo, Yun-Ho
Jan 23, 2024 06:02am
¡®Verzenio¡¯, which faced difficulties in expanding its reimbursement standards last year, is now drawing attention to see if it will pass the review this time. According to industry sources, Lily Korea¡¯s CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the Health Insurance Review and Assessment Service (HIRA)
Policy
Luxturna, Kerendia, & Raspirin will get new reimb standards
by
Lee, Jeong-Hwan
Jan 22, 2024 05:49am
New reimbursement standards will be established for Novartis¡¯s Luxturna, a one-shot retinal dystrophy treatment, Hanmi Pharmaceutical¡¯s Raspirin Cap, and Bayer¡¯s Kerendia Tab 10 mg, as they are set to be listed for reimbursement. Reimbursement standards will be set for Takeda¡¯s Obizur, a treatment for acquired hemophilia A, and Pfiz
Company
Sotatercept receives orphan drug designation in Korea
by
Eo, Yun-Ho
Jan 22, 2024 05:49am
Sotatercept, a new drug candidate for pulmonary arterial hypertension (PAH), has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced the drug¡¯s designation in the first orphan drug designation announcement it made in the new year. Sotatercept, which is being developed by Merck, is being re
Company
First oHCM drug Camzyos applies for reimb in Korea
by
Eo, Yun-Ho
Jan 22, 2024 05:49am
The first-ever obstructive hypertrophic cardiomyopathy (oHCM) treatment, ¡®Camzyos,¡¯ is being reviewed for reimbursement in Korea. According to industry sources, BMS Korea has recently applied for the reimbursement listing of its new obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten). Therefore, whether the drug
Policy
Forxiga withdraws from the Korean mkt despite reimbursement
by
Lee, Tak-Sun
Jan 22, 2024 05:48am
The SGLT-2 inhibitor ¡®Forxiga Tab,¡¯ which its company plans to withdraw from the Korean market in the first half of the year, will now be reimbursed for chronic heart failure. However, the withdrawal of the drug from the market has put a damper on the reimbursement expansion. Even if it is reimbursed from next month, there will inevitab
Policy
P3T for chin fat reduction injection ¡®AYP-101¡¯ approved
by
Lee, Hye-Kyung
Jan 19, 2024 05:45am
A Phase III trial for Amipharm's 'AYP-101', an injectable drug for submental fat reduction, will be conducted in Korea. On the 16th, the Ministry of Food and Drug Safety approved a Phase III clinical trial to ¡®evaluate the efficacy and safety of AYP-101 in reducing submental fat in adults with moderate-to-severe convexity or fullness ass
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