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Home » Topics » Regulatory » MOHW

MOHW
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Novo Nordisk to launch Wegovy in South Korea mid-October

Oct. 7, 2024
By Marian (YoonJee) Chu
Danish pharma giant Novo Nordisk A/S is set to launch its blockbuster glucagon-like peptide-1 therapy, Wegovy (semaglutide), in South Korea’s growing obesity therapeutics market next week, a company official confirmed to BioWorld.
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Pharos PHI-101

Pharos Ibio wins MFDS orphan drug designation for AML drug

Sep. 10, 2024
By Marian (YoonJee) Chu
South Korean artificial intelligence-based drug developer Pharos Ibio Co. Ltd. said that the Ministry of Food and Drug Safety (MFDS) granted an orphan drug designation for PHI-101, a second-line therapy for acute myeloid leukemia (AML).
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Pharos PHI-101

Pharos Ibio wins MFDS orphan drug designation for AML drug

Sep. 5, 2024
By Marian (YoonJee) Chu
South Korean artificial intelligence-based drug developer Pharos Ibio Co. Ltd. said that the Ministry of Food and Drug Safety (MFDS) granted an orphan drug designation for PHI-101, a second-line therapy for acute myeloid leukemia (AML).
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Yunovia cleared for Korea phase I trial of small-molecule GLP-1 asset

Sep. 3, 2024
By Marian (YoonJee) Chu
Yunovia Co. Ltd. gained clearance in South Korea to start a multiple ascending dose phase I study for ID-110521156 – a novel, orally available, small-molecule, glucagon-like peptide-1 (GLP-1) agonist.
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Yunovia cleared for Korea phase I trial of small-molecule GLP-1 asset

Aug. 28, 2024
By Marian (YoonJee) Chu
Yunovia Co. Ltd. gained clearance in South Korea to start a multiple ascending dose phase I study for ID-110521156 – a novel, orally available, small-molecule, glucagon-like peptide-1 (GLP-1) agonist.
Read More
K DTx VIVIDBrain

Korea taps into AI, DTx boom with new approvals, investments

April 24, 2024
By Marian (YoonJee) Chu
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
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Samsung Bioepis building

Samsung Bioepis wins nod for Korea’s first Stelara biosimilar

April 12, 2024
By Marian (YoonJee) Chu
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
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Samsung Bioepis building

Samsung Bioepis wins nod for Korea’s first Stelara biosimilar

April 12, 2024
By Marian (YoonJee) Chu
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
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Pills, syringes, financial charts

Curbing ‘financial toxicity’ key to biotech success, expert says

April 9, 2024
By Marian (YoonJee) Chu

“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea.


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Pills, syringes, financial charts

Curbing ‘financial toxicity’ key to biotech success, expert says

April 5, 2024
By Marian (YoonJee) Chu

“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea.


Read More
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