Pharma & Bio
Technology
SK Biopharm Rallies on Opakalim Bet; Xcell Hits Intraday Upper Limit [K-Bio Pulse]
On Aug. 26, SK Biopharmaceuticals jumped 8.53% after announcing a licensing deal worth up to $795 million for its late-stage epilepsy drug candidate Opakalim, regaining the 90,000-won level following …
Technology
SK BIOPHARMACEUTICALS Soars 8% on 1.1 Trillion Won New Drug Deal… Xcell Therapeutics Inc. Hits Intraday High [Bio Spotlight]
On the 26th, buying interest surged in the biotech and healthcare sector, driven by companies seeking new growth engines. SK BIOPHARMACEUTICALS(326030)saw its stock price—which had recently been under…
Technology
Rejuran Injected into My Face—Still Not Approved in the U.S.?
PharmaResearch(214450)is seeking U.S. Food and Drug Administration (FDA) medical device approval for its flagship product, “Rejuran,” but is expected to face significant hurdles before actually enteri…
Technology
Seegene Inc., Whose 70% of Revenue Came from COVID-19 and Respiratory Diseases… Reduces ‘Winter Dependency’ Through GI and HPV Tests
Seegene ( Seegene Inc.(096530)), whose revenue was heavily concentrated in respiratory diagnostics during the COVID-19 pandemic, is now cultivating non-respiratory products—such as gastrointestinal (G…
Technology
Kim Nam-yong, CEO of Curiox: "More Order Contracts and Advance Payment Agreements with Global Companies Are Expected"
“We recently secured an equipment order worth 510 million won from a global pharmaceutical company in the cell and gene therapy (CGT) sector. We are currently in active discussions with more than 10 g…
Lifestyle
Sillajen Hits Upper Limit on FDA Orphan Drug Designation, Hanmi Pharma Plunges [K-Bio Pulse]
While South Korea’s pharmaceutical and biotech sector traded lower across the board, Sillajen stood out by hitting the daily upper price limit. In contrast, Hanmi Pharmaceutical and Hanmi Science, whi…
Lifestyle
SillaJen Hits Daily Price Limit After FDA Orphan Drug Designation; Hanmi Pharmaceutical Plummets Just One Day After Technology Transfer [Bio Spotlight]
While the domestic pharmaceutical and biotech sector showed a generally weak performance, SillaJen drew attention by hitting the daily price limit. In contrast, Hanmi Pharmaceutical and Hanmi Science,…
Lifestyle
[Exclusive] Ministry of Food and Drug Safety: “Confirmed that ‘SeraQ’ promotional materials plagiarized another company’s raw material data”… False and Exaggerated Advertising Uncovered
It has been confirmed that the Ministry of Food and Drug Safety (MFDS) has initiated administrative sanctions and legal proceedings against Company M, a multi-level marketing firm, for false and exagg…
Technology
Samsung and BMS Join the Bispecific Antibody-Drug Conjugate (ADC) Race… IntoCell, Inc. Remains Cautious
#IntoCell, Inc. has drawn attention by expressing a somewhat skeptical stance toward bivalent antibody-drug conjugates (ADCs), which are garnering global attention as next-generation cancer treatments…
Technology
U.S. FDA to Revise Guidelines for Drug Containers… Samsung and Celltrion’s Biosimilars Also Affected
The first page of the draft “Guidance for Industry on Container Closure Systems (CCS) for Human Drugs and Biological Products.” (Graphic: Generative AI)
The U.S. Food and Drug Administration (FDA)…