With few days left until the authorization of Korea’s first homegrown Covid-19 vaccine SKYCovione, the Korean regulatory agency’s enhanced review capabilities are drawing attention.In a meeting with healthcare news reporters on Tuesday, National Institute of Food and Drug Safety Evaluation (NIFDS) D
Daewoong Pharmaceutical said it would develop a chronic skin disease treatment jointly with Scai Therapeutics, a drug delivery platform bio-venture, using transdermal absorption technology.The two companies will apply Scai Therapeutics' proprietary technology to develop a transdermal absorbable form
Bioneer, a company specializing in PCR reagents and equipment, said Wednesday that it has developed the AccuPower Monkeypox Detection Kit to detect monkeypox.The device is based on Bioneer’s patented technology, PyroHotstart. It can amplify the monkeypox virus with high sensitivity to extract the DN
Health officials said the declining trend of Covid-19 has reached its limit, predicting new infections might likely rebound in the short run."We think that the decline in the spread of Covid-19 of the past few weeks has reached its limit," said Im Sook-young, a senior official at the Central Disease
Novartis Korea said Tuesday that it obtained permission from the Ministry of Food and Drug Safety on June 9, to market Scemblix to treat adults with chronic myeloid leukemia who had received two or more tyrosine kinase inhibitors (TKI).Chronic myeloid leukemia is a malignant blood disease caused by
Hanmi Pharmaceutical said it would exclusively distribute Alivecor’s KardiaMobile 6L, a mobile electrocardiograph that can easily measure electrocardiograms using smartphones and stick-type devices, to clinic-level medical institutions nationwide.The device measures the electrocardiogram by touching
Helixmith has decided to postpone announcing the interim results of the U.S. phase 3 clinical trial for diabetic peripheral neuropathy (DPN) using its new gene therapy, Engensis (VM202), until next month, its top manager said.The company had planned to share the results of the Independent Data Monit
Celltrion said it would change its strategy for developing a Covid-19 treatment to respond to the rapidly changing pandemic situations after the emergence of the Omicron variant.For instance, the company will scrap its plan to develop an inhaled cocktail antibody treatment that adds CT-P63, a candid
“The paradigm in healthcare services shifted toward patient-centered care. As a result, the results of patient experience evaluation will directly affect the profits of medical institutions and all medical indices. Therefore, patient experience evaluation will grow more in the future.”So said Kim Sa
GI Innovation said it obtained a substance patent of GI-101, its key immunotherapy candidate, in the U.S.On Monday, the company said it registered the GI-101 patent with a wide range of rights without amino sequence restrictions in the U.S. which accounts for 60 percent of the global biopharmaceutic
Seegene said Tuesday it has developed a diagnostic reagent for the monkeypox virus, Novaplex MPXV Assay, using its AI-based automatic reagent development system, Seegene Digitalized Development System (SGDDS).Since the first discovery of the monkeypox virus in the U.K. last month, the African endemi
The Ministry of Food and Drug Safety (MFDS) said Tuesday it has developed a pulse wave simulation device by applying "human body-imitating technology" to minimize device errors in sphygmographs that measure blood vessel pulsation.A pulse meter measures pulses in blood vessels to predict vascular sti
Dae Hwa Pharm said it applied to the drug regulator for a change in the post-marketing surveillance (PMS) plan for Liporaxel (ingredient: paclitaxel), chemotherapy to extend the September deadline of the drug re-evaluation.The Ministry of Food and Drug Safety’s central pharmaceutical review committe
BL, a new drug developer, said Monday that it has obtained approval for administering patients with BLS-H01, a drug aimed at treating all Covid-19 variants.The Institutional Review Board (IRB) of Gachon University Gil Medical Center approved the phase 2 clinical trial of BLS-H01, a medication for Co
Korea’s new Covid-19 cases hit the lowest level in five-and-a-half months on Monday. However, experts warned a possible resurge this summer could be worse than last year’s, noting the nation has lifted almost all restrictions.The nation’s new virus cases fell below 3,500 on Monday as the Covid-19 pa
“In conducting this study, I met many insiders of the active pharmaceutical ingredient (API) industry, and most of them said, ‘We are like abandoned children,’ or ‘Everyone knows that the pharmaceutical industry can hardly move forward without a competitive API sector. Unfortunately, however, the go
Kalos Medical said Monday that it would start recruiting patients for exploratory clinical trials of DENEX, Korea's first hypertension treatment medical device, in four European countries.The company will conduct the clinical trial at 21 institutions in Greece, Germany, Italy, and Poland, by recruit
A group of nephrologists at Seoul National University Bundang Hospital (SNUBH) has built a model to evaluate the nephrotoxicity of computerized tomography (CT) contrast agents, using 3D tissue chip technology.The research team, led by Professor Kim Se-joong of the Nephrology Department, created a hu
The number of medical tourists visiting Korea expanded 24.6 percent year-on-year in 2021, despite the Covid-19 pandemic, government data showed.However, foreign patients seeking dermatology care decreased, and the proportion of medical tourists visiting the Seoul metropolitan area also fell last yea
The Ministry of Food and Drug Safety released the results of the expert review on SK Bioscience’s SKYCovione (pipeline name: GBP510), the nation’s first homegrown Covid-19 vaccine, and said the data was sufficient to confirm approval.However, some criticized the government, saying it unfairly and pr