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2025-11-04 13:29
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'Will accelerate innovation through AI and clinical focus'
by
Hwang, byoung woo
Oct 21, 2025 06:20am
¡°AI is now at the heart of drug development. We must make our clinical support system more flexible and manage budgets more efficiently.¡± At the 2025 European Society for Medical Oncology (ESMO)&8212;one of the world¡¯s largest cancer conferences&8212;Dr. Yeong-Min Park, Director of the Korea Drug Development Foundation (KDDF), stressed t
Company
Pluvicto demonstrates first-line efficacy in prostate cancer
by
Hwang, byoung woo
Oct 21, 2025 06:19am
Novartis¡¯ radioligand therapy Pluvicto (lutetium vipivotide tetraxetan; [©ö&8311;&8311;Lu]Lu-PSMA-617) has demonstrated a clinically meaningful benefit as first-line treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC). This is considered the first Phase III evidence confirming Pluvicto's potential to extend beyo
Company
Eliquis 13%, Xarelto 49% of DOAC Generics mkt
by
Kim, Jin-Gu
Oct 21, 2025 06:19am
In Korea¡¯s direct oral anticoagulant (DOAC) market, Eliquis (apixaban) generics have regained a 13% market share within a year of re-entering the market. However, that figure remains roughly half the level prior to their withdrawal. By contrast, Xarelto (rivaroxaban) generics have continued to expand their presence, reaching a 49% market sha
Policy
Parliamentary inspection of the MFDS to highlight
by
Lee, Jeong-Hwan
Oct 21, 2025 06:19am
During the upcoming parliamentary inspection of the Ministry of Food and Drug Safety (MFDS), the National Assembly is expected to highlight the need to increase the number of reviewers and support the formation of dedicated teams to provide customized approval services, all aimed at shortening the review period for domestically developed new
InterView
"GI Innovation challenges melanoma"
by
Hwang, byoung woo
Oct 21, 2025 06:18am
GI Innovation is accelerating its entry into the global market. The company unveiled clinical data for its new immunotherapy drug candidate, 'GI-102,' at the ESMO Congress 2025 (European Society for Medical Oncology). GI-102 is drawing attention for its potential to overcome resistance, as it showed clinical improvement, including tumor shri
Company
'Rezurock' for cGVHD enters NHIS drug price negotiation
by
Eo, Yun-Ho
Oct 20, 2025 06:08am
'Rezurock,' a treatment for the treatment of chronic graft-versus-host disease (cGVHD), has entered the last stage for insurance reimbursement listing. Sanofi Korea and the National Health Insurance Service (NHIS) are currently under negotiations for the drug pricing of the ROCK2 inhibitor 'Rezurock (belumosudil). Rezurock is a pharma
Company
Enhertu redefines the standard in early-stage breast cancer
by
Hwang, byoung woo
Oct 20, 2025 06:08am
The antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan, T-DXd) has taken center stage as a new cornerstone in the treatment strategy for early-stage breast cancer. Both the DESTINY-Breast05 and DESTINY-Breast11 trial results that were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin showed signi
Company
'Keytruda+Padcev' proposed as a new standard trt for MIBC
by
Hwang, byoung woo
Oct 20, 2025 06:07am
Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) have demonstrated synergistic effects in muscle-invasive bladder cancer (MIBC), opening up new possibilities. Analysis suggests that the combination of enfortumab vedotin and pembrolizumab may shift the perioperative standard of care for MIBC patients who are ineligible for or refuse ci
Company
Alecensa achieves 81-month median overall survival
by
Hwang, byoung woo
Oct 20, 2025 06:07am
Roche's ALK inhibitor Alecensa (alectinib) has demonstrated long-term survival benefits exceeding 7 years in patients with ALK-positive advanced non-small cell lung cancer (NSCLC). In the final overall survival (OS) analysis of the Phase III ALEX study, Alecensa showed a clear survival benefit over existing treatments, reaffirming its status
Company
Ipsen's Bylvay is officially launched in Korea
by
Son, Hyung Min
Oct 20, 2025 06:06am
&160;Ipsen Korea is introducing a treatment for progressive familial intrahepatic cholestasis (PFIC), an extremely rare hereditary liver disease, to the domestic market. This launch opens new hope for pediatric patients who previously had no treatment option beyond liver transplantation. Bylvay has been selected as the first product unde
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