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2025-07-19 07:58
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PKU drug Sephience receives orphan drug designation in KOR
by
Eo, Yun-Ho
Jul 7, 2025 06:10am
Sephience, a new drug for phenylketonuria (PKU), a rare metabolic disorder, has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced so through a public notice. Specifically, the drug is indicated&160;for the treatment of hyperphenylalaninaemia (HPA) in adult and pediatric patients with ph
Company
¡®Need to institutionalize reinvestment of funds into R&D'
by
Kim, Jin-Gu
Jul 7, 2025 06:09am
A recommendation was made for the implementation of a system that reinvests the savings from drug price reductions by pharmaceutical and biotech companies into R&D for new drugs and ensures a fixed price during the early stages of a new drug's market launch. Professor Jeonghoon Ahn of the Department of Convergence Health Sciences at Ewha
Company
'Tecentriq' reattempts at lung cancer adjuvant therapy reimb
by
Eo, Yun-Ho
Jul 4, 2025 06:06am
'Tecentriq,' immunotherapy for cancer, will be submitted again for expanded insurance reimbursement of adjuvant therapy for lung cancer. According to our press coverage, Roche Korea applied for expanded reimbursement of its PD-L1 inhibitor Tecentriq (atezolizumab) and is awaiting review by the Cancer Disease Review Committee (CDRC) of the
Company
Will the external reference pricing reevals be resumed?
by
Kim, Jin-Gu
Jul 4, 2025 06:06am
Tensions are rising in the pharmaceutical and biotech industry amid speculation that the external reference pricing reevaluations may be pushed forward again in the second half of this year. The industry is reacting sensitively, as the proposal previously discussed by the consultative body could lead to large-scale drug price cuts if adopted as
Company
Lilly launches Ebglyss in Korea¡¦ sparks competition
by
Son, Hyung Min
Jul 3, 2025 06:12am
The official launch of Lilly's Ebglyss has expanded treatment options for atopic dermatitis patients in Korea. With the arrival of Ebglyss, the number of biological agents available for the treatment of atopic dermatitis in Korea has increased to three. Experts welcomed the emergence of diverse treatment options but emphasized that there i
Company
Will twice-yearly Bayer's 'Eylea' become available in KOR?
by
Eo, Yun-Ho
Jul 3, 2025 06:12am
Twice-yearly administration of 'Eylea,' used to treat eye disease, is anticipated to be possible in South Korea. The Ministry of Food and Drug Safety (MFDS) is conducting a review of the expanded indication for the administration of Bayer Korea's high-dose Eylea (aflibercept) 8 mg at intervals of up to 6-months. The approval is expected i
Company
Pharma tries to flip the returned out-licensing of new drugs
by
Son, Hyung Min
Jul 3, 2025 06:11am
New drug candidates from Korean pharmaceutical companies, which were previously returned after technology transfer, are now re-entering the clinical stage and proving their potential. Attention is focused on whether these candidates will re-label their past failures and demonstrate technological potential. According to industry sources on Jul
Company
SK Bioscience invests billions in the post-pandemic era
by
Chon, Seung-Hyun
Jul 3, 2025 06:10am
SK Bioscience has taken proactive steps to discover new growth engines in preparation for the post-pandemic era. The company has invested KRW 81.5 billion to expand its vaccine plant in Andong and approximately KRW 300 billion for the acquisition of a German CDMO biotech company. The construction of its headquarters, research center, and factory
Company
AbbVie Korea launches new glaucoma treatment 'XEN 63'
by
Whang, byung-woo
Jul 3, 2025 06:08am
AbbVie Korea announced on July 1 that it has launched XEN 63, a new option for glaucoma treatment in patients whose intraocular pressure (IOP) is not controlled by previous glaucoma surgery or existing medicines. With the expansion of the XEN Gel Implant portfolio, including XEN 45, patients now have a wider range of personalized treatment
Company
Leclaza combination therapy takes over Europe
by
Moon, sung-ho
Jul 3, 2025 06:07am
Leclaza (lazertinib), a new lung cancer drug developed by Yuhan Corporation, has been officially included in the European Society for Medical Oncology (ESMO) guidelines. Reflecting the latest clinical study findings, Leclaza in combination with Rybrevant (amivantamab, Johnson & Johnson) has been included as a first-line option in the guidelin
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