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Home » Authors » Haky Moon

Articles by Haky Moon

South Korea continues to boost biopharma sector, tightening review process

Feb. 2, 2016
By Haky Moon
HONG KONG – The Korean Ministry of Food and Drug Safety (MFDS) is shortening the biologics review process for rare and incurable diseases to speed up the approvals and overseas distribution of Korea-developed biopharmaceuticals. Although details of the policy are sketchy and yet to be disclosed, the announcement marks the country’s determination to make biopharmaceuticals a core industry.
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'A lot of firsts,' as Korean firm Viromed advances gene therapy

Feb. 1, 2016
By Haky Moon
HONG KONG – With the successful completion of a phase II study in the U.S. for its flagship product, VM202, for the treatment of critical limb ischemia (CLI), South Korean biopharma Viromed Co. Ltd. is off to a good start this year.
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AEC modeled on European Union: ASEAN growing local med-tech industry via newly launched AEC

Jan. 25, 2016
By Haky Moon

Samsung Bioepis stepping into EU market with Enbrel biosimilar

Jan. 20, 2016
By Haky Moon and Cornelia Zou
HONG KONG – South Korea's Samsung Bioepis Co. Ltd. got the first EU approval for biosimilar etanercept, a win that opens up the European market for a company that is working to become a global top-tier biosimilar maker.
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Samsung Bioepis steps into EU market with Enbrel biosimilar

Jan. 20, 2016
By Haky Moon and Cornelia Zou
HONG KONG – South Korea's Samsung Bioepis Co. Ltd. got the first EU approval for biosimilar etanercept, a win that opens up the European market for a company that is working to become a global top-tier biosimilar maker.
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JVs Allowed to Import Products: Myanmar finally okays med-tech joint ventures with international companies

Jan. 7, 2016
By Haky Moon

Samsung expanding biopharma ambitions, with 'world's largest' production facility

Dec. 24, 2015
By Haky Moon
HONG KONG – Samsung Biologics broke ground this week on its third and largest biopharmaceutical production plant. Once completed, the company expects the KRW850 billion (US$722 million) plant in Incheon, Korea, to be the largest in the world.
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Samsung expanding biopharma ambitions, with 'world's largest' production facility

Dec. 23, 2015
By Haky Moon
HONG KONG – Samsung Biologics broke ground Monday on its third and largest biopharmaceutical production plant. Once completed, the company expects the KRW850 billion (US$722 million) plant in Incheon, Korea, to be the largest in the world.
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Step towards bilateral investment treaty: Commercial accords might well serve to improve US access to Chinese market

Dec. 16, 2015
By Haky Moon

Samsung continues biosimilar expansion with Renflexis approval

Dec. 16, 2015
By Haky Moon
HONG KONG – Marking another step forward for South Korea's leading biosimilar developer, the Ministry of Food and Drug Safety (MFDS) approved domestic sales of Samsung Bioepis Co. Ltd.'s Renflexis (infliximab), a biosimilar of Johnson & Johnson's Remicade (infliximab). This is the second marketing approval for the company this year.
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