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Korea To Limit Olmutinib Usage, Monitor All Patients

 
• By Jung Won Shin

After distributing safety letters on several cases of serious adverse skin reactions that occurred during the clinical development of Hanmi’s olmutinib, South Korean authorities have decided to limit the EGFR inhibitor to consenting patients and are closely monitoring its use.

South Korea’s Ministry of Food and Drug Safety has decided to limit the usage of Hanmi Pharmaceutical Co. Ltd.'s EGFR inhibitor olmutinib only to patients who agree to use the drug after receiving thorough explanations from doctors on possible side effects including serious adverse skin reactions.

Olmutinib, which was approved in the country in May and launched for the first time globally in the country earlier this year, as Olita, is used in terminal non-small cell...

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MetaVia Sees Obesity Opportunities Despite Challenging US Market

 
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Despite new challenges related to obesity drug insurance coverage in the US, MetaVia's CEO is confident in the company's novel contender, which unlike rival GLP-1 therapies doesn’t require dose titration.

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Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
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South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
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Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
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