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2025-06-16 07:00
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New RNAi drug 'Rivfloza' gets ODD in KOR
by
Eo, Yun-Ho
Jun 16, 2025 06:04am
The rare genetic disorder treatment 'Rivfloza' has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety recently announced this on its notification board. Rivfloza (nedosiran) is indicated to treat children over 9 years of age and above and adults with 'primary hyperoxaluria type 1 (PH1)' and relatively p
Policy
Atopic dermatitis drug Ebglyss reimbursed from next month
by
Lee, Tak-Sun
Jun 16, 2025 06:03am
With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ¡®Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)¡¯ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis
Policy
Roche¡¯s SMA drug Evrysdi Tab approved in Korea
by
Lee, Hye-Kyung
Jun 16, 2025 06:03am
The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ¡®Evrysdi 5 mg (risdiplam).¡¯ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet fo
Company
Anti-PD-1 immunotherapy 'Zynyz' gets ODD in KOR
by
Eo, Yun-Ho
Jun 16, 2025 06:02am
The checkpoint inhibitor immunotherapy 'Zynyz' has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) has recently announced this through its notification board. It is indicated to treat relapsed or metastatic locally advanced Merkel cell carcinoma (MCC). Zynyz (retifanlimab) obtained U.S.
Company
Denosumab¡¯s reimbursement denials increase due to stricter
by
Moon, sung-ho
Jun 16, 2025 06:02am
Although the government extended the reimbursed period for denosumab-based osteoporosis treatments last year, concerns about reimbursement denials continue in practice. Major medical societies, such as the Korean Endocrinology Society, have reached the point where they have issued guidelines to prevent insurance reimbursement cuts when prescr
Company
Latecomer psoriasis drug Bimzelx enters competition in KOR
by
Whang, byung-woo
Jun 13, 2025 06:03am
The new psoriasis treatment Bimzelx (bimekizumab) has cleared the reimbursement hurdle and is now officially entering Korea¡¯s market competition. With numerous psoriasis treatment options already on the market, the drug is expected to target new patients based on its relatively low drug price. On the 12th, UCB Korea held a press conferenc
Company
New ADC drug Padcev seeks reimb again in Korea
by
Eo, Yun-Ho
Jun 13, 2025 06:03am
The ADC bladder cancer drug Padcev is once again attempting reimbursement listing in Korea. According to Dailypharm coverage, Astellas Pharma Korea recently submitted a reimbursement application for its antibody-drug conjugate (ADC) Padcev (enfortumab vedotin). Accordingly, it will be interesting to see whether the company will be able
Company
Pharma-distributor 'margin war' heats up again
by
Son, Hyung Min
Jun 13, 2025 06:03am
The pharmaceutical industry and distribution industry are in conflict over profit margins. Janssen Korea reportedly notified its training companies of a 2%p reduction in margins and continuing negotiations with individual companies. Some domestic pharmaceutical companies are implementing margin reductions starting this year. Pharmaceutical co
Policy
Ruling party proposes bill for free HPV vaccination
by
Lee, Jeong-Hwan
Jun 13, 2025 06:02am
The Democratic Party of Korea has submitted a bill to the National Assembly to significantly expand the scope of Korea¡¯s National Immunization Program for human papillomavirus (HPV) vaccines. The bill proposes to provide free HPV vaccinations to all males and females aged 12 to 26, regardless of gender or income level. This legislatio
Company
Distributors Association plans "strong response"
by
Son, Hyung Min
Jun 13, 2025 06:01am
The Korean pharmaceutical distribution industry is rallying around the Korea Pharmaceutical Distributors Association in response to Janssen Korea's reduction of&160;distribution margins. Park Ho-young, Chairman of the Korea Pharmaceutical Distributors Association, described Janssen Korea's margin reduction as an&160;arbitrary act&160;rath
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