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2025-02-07 04:14
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Twice yearly HIV drug 'lenacapavir' receives ODD
by
Eo, Yun-Ho
Jan 7, 2025 06:05am
Twice yearly injectable 'lenacapavir' for HIV prevention has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) recently announced this through the new year's first orphan drug designation notification. The drug is indicated 'In combination with other antiretroviral therapy, for treatment of p
Policy
Dong-A ST first to pay the raised new drug approval fee?
by
Lee, Hye-Kyung
Jan 7, 2025 06:05am
With the new drug approval fee raised to KRW 410 million on Jan. 1 this year, the industry is eyeing whether Dong-A ST will become the first to apply for marketing authorization and pay the raised new drug approval fee. According to industry sources on the 7th, Dong-A ST applied for a prior consultation before applying for marketing authoriza
Company
AstraZeneca Korea recertified Innovative Pharma Company
by
Whang, byung-woo
Jan 7, 2025 06:05am
AstraZeneca Korea announced today that it has successfully extended its certification as a 2024 Innovative Pharmaceutical Company by the Ministry of Health and Welfare. This marks the third consecutive recertification since the company was first certified in 2018, and recognizes the company's steady R&D investments and achievements made t
Product
Will doctor-pharmacist conflict reignite?
by
Kim JiEun
Jan 7, 2025 06:05am
With candidate Joo Soo-ho, who advocates for the selective dispensing of drugs, advancing to the runoff election for the new president of the Korean Medical Association, a potential conflict between the medical community and the pharmaceutical association is expected. In the 43rd presidential election of the Korean Medical Association, wh
Opinion
[Reporter's View] Switching of drugs reimbursable
by
Eo, Yun-Ho
Jan 6, 2025 05:57am
When a patient chooses one medication and switches to another, reimbursement does not cover the latter. Non-reimbursable drug switching has been a long-standing issue in South Korea. At the end of last year, a long-standing issue in one field was resolved. The Ministry of Health and Welfare (MOHW) granted approval for drug switching for p
Policy
Zolgensma shows 94% effect during post-evaluations
by
Lee, Tak-Sun
Jan 6, 2025 05:56am
The spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) showed promising results suited to its high price. The use of the once-daily, one-shot treatment, which has an insurance cap set at KRW 2, requires a post-marketing evaluation to measure its cost-effectiveness. According to industry sources on the 5th, Z
Company
1st RSV preventive inj 'Beyfortus' can be prescribed
by
Eo, Yun-Ho
Jan 6, 2025 05:56am
The first injectable antibody drug approved in South Korea to prevent respiratory syncytial virus (RSV), 'Beyfortus,' is now available for prescription at general hospitals. According to industry sources, Sanofi Korea's Beyfortus (nirsevimab) has passed the drug committees (DC) of medical centers, including Seoul National University Hospi
Company
Balversa may be prescribed at general hospitals in Korea
by
Eo, Yun-Ho
Jan 6, 2025 05:56am
The new bladder cancer drug Balversa may now be prescribed in Korea¡¯s Big 5 tertiary hospitals in Korea. According to industry sources, Janssen Korea's FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul Na
Policy
MFDS¡¯s 2nd GIFT drug Nefecon applies for reimbursement
by
Lee, Tak-Sun
Jan 6, 2025 05:56am
Nefecon (micronized budesonide), the only drug approved by the U.S. FDA to treat lgA (immunoglobulin A) nephropathy, has applied for domestic health insurance reimbursement coverage in Korea. The drug was approved in November last year as its 2nd GIFT (Global Innovative Drug Fast Track) drug, MFDS¡¯s fast track program. According to in
Company
Lily's 'Jaypirca' launches in KOR
by
Whang, byung-woo
Jan 3, 2025 06:28am
Lily Korea announced on January 2 that Jaypirca (ingredient name: pirtobrutinib), a treatment for mantle cell lymphoma (MCL), was launched in South Korea on December 26. To date, Jaypirca is the first reversible Bruton's tyrosine kinase (BTK) inhibitor of any kind. Jaypirca was approved by the Ministry of Food and Drug Saftey (MFDS) i
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