5th Korea-Japan Joint Pharmaceutical Symposium: Enhancing Collaboration and Regulatory Innovation in the Biopharmaceutical Industry
The Bio Pharmaceutical Society of Korea Announces the 5th Korea-Japan Joint Pharmaceutical Symposium In an effort to support the growth and collaboration of the biopharmaceutical industries in Korea and Japan, the Bio Pharmaceutical Society of Korea, led by Chairman Noh Yeon-hong, has announced the upcoming ‘5th Korea-Japan Joint Pharmaceutical Symposium’. The event, organized by both […]
Cell in Cells Receives Approval for Clinical Trial of Organoid Skin Regeneration Treatment
Cell in Cells Receives IND Approval for Organoid Skin Regeneration Treatment Jae-jin Cho, CEO of Cell in Cells, announced on the 16th that the company has obtained approval for its clinical trial plan (IND) from the Food and Drug Safety Administration. This approval is for their first pipeline, a new drug candidate called TRTP-101, which […]
Daewon Pharmaceutical Resumes Production of Chol Daewon Kids Pen Syrup After Ban Lifted
Daewon Pharmaceutical to Resume Manufacture and Sale of Chol Daewon Kids Pen Syrup Lifting of Ban Prompts Swift Action Daewon Pharmaceutical, under the leadership of CEO Baek Seung-yeol, has announced its intention to recommence the manufacture and sale of ‘Chol Daewon Kids Pen Syrup’. The decision comes in the wake of the Ministry of Food […]
Industry Speculation Surrounds Potential Scope of GMP Suitability Decision Cancellation for Korea Hutex Pharmaceuticals
Scope of Cancellation for GMP Suitability Decision on Hutex Pharmaceuticals Raises Industry Concerns There is growing anticipation within the industry regarding the scope of the cancellation of the first Good Manufacturing Practice (GMP) suitability decision for Korea Hutex Pharmaceuticals. The main question is whether the cancellation will apply to the entire large-scale dosage form or […]
Medtronic’s ‘DLP Pediatric One-Piece Artery Cannulae’ Designated as Urgently Needed Rare Medical Device for Cardiopulmonary Surgery
Medtronic’s ‘Vascular Tubes and Catheters for Cardiopulmonary Surgery’ Granted Urgently Needed Rare Medical Device Designation On the 31st, the Food and Drug Safety Administration designated four newly developed products by Medtronic as ‘urgently needed rare medical devices’. Among these products is the ‘DLP Pediatric One-Piece Artery Cannulae’, a crucial tool for cardiopulmonary surgery. Understanding the […]
Digital Tinnitus Treatment Device Begins Clinical Trial for FDA Approval
New Clinical Trials Approved for Medical Devices in July The Ministry of Food and Drug Safety has granted approval for 14 clinical trials of medical devices this month. Among these, 10 trials are confirmed as confirmatory clinical trials in order to obtain licenses for the devices. The approved trials include the development of skin cancer […]
Balancing Global L/O and Traditional Pharmaceutical Exports: Challenges for Korean New Drug Development
The Significance of Pharmaceutical Exports in the Korean Biopharmaceutical Industry The Korean biopharmaceutical industry faces numerous challenges, with one of the key hurdles being global technology export. Due to limitations in funding and manpower, the most pragmatic approach for Korean new drug development bioenterprises is licensing and outsourcing (L/O) their technologies. While this may limit […]
Examining the Problem of Arbitrary Pharmaceutical Manufacturing: Causes, Consequences, and System Improvements
Concerns mount over arbitrary drug manufacturing and its impact on public health Introduction Despite strengthened inspections and increased administrative punishments, pharmaceutical companies continue to be exposed for violations in drug manufacturing and quality control (GMP). One of the most concerning issues is the practice of ‘random manufacturing’ where medicines produced differ from the approved formulations, […]
Sanofi-Aventis Korea receives item approval for ‘Genpozyme Inj’ to treat rare disease ASMD
Sanofi-Aventis Korea, under the leadership of CEO Bae Eun-eun, has recently obtained item approval from the Ministry of Food and Drug Safety for its groundbreaking treatment, ‘Genpozyme Inj.’ This significant development marks a major breakthrough in the field of rare diseases. One such rare condition that this treatment targets is Acid Sphingomyelinase Deficiency (ASMD). ASMD […]
Korea Hutex Pharmaceuticals Faces Punitive Penalty for GMP Suitability Award Cancellation
Korea Hutex Pharmaceuticals Faces Punitive Penalty for GMP Violations The Ministry of Food and Drug Safety has taken action against Korea Hutex Pharmaceuticals for violating the Pharmaceutical Affairs Act. As a result, the manufacture and sale of six items from the company have been suspended. These items include Recutin Tab, Loxacin Tab, Eddy Tab, Zalnagel […]
