Icure Pharmaceutical's good manufacturing practice (GMP) violations have led to widespread administrative penalties.According to the Ministry of Food and Drug Safety, Chong Kun Dang and Dongkook Pharmaceutical's pain-relieving patch Kefem Plaster and Sarafen Plaster received a three-month administra
JW Pharmaceutical is drawing attention by reapplying for the global phase 3 clinical trial of its gout treatment candidate, epaminurad (URC102).The company said in a public filing Monday that it has submitted the renewed application to the Taiwan Food and Drug Administration (TFDA).JW Pharmaceutical
Korean pharmaceutical companies and distributors supplied about 89 trillion won ($68.2 billion) worth of drugs last year, an increase of 10.2 percent from 2021.In particular, the production of Covid-19 vaccines and cold medicines increased significantly.The Health Insurance Review and Assessment Ser
Local doctors have expressed concerns about Eli Lilly Korea's notice about an upcoming shortage of Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist that treats type 2 diabetes.Lilly Korea recently sent out a notice to local doctors stating that the company expects to experience a shorta
Samil Pharmaceutical, a Korean drugmaker, is expanding its business in the central nervous system (CNS) field after acquiring domestic sales rights for Sandoz Korea's products.Earlier in May, Sandoz, a Novartis' generics and biosimilars business unit, said it will wind down its Korean operations. At
EuBiologics said on Monday that its Covid-19 vaccine, EuCorVac-19, confirmed safety and efficacy based on phase 3 interim results and plans to apply for marketing authorization in the Philippines this month.EuCorVac-19 is a recombinant protein vaccine using the company’s proprietary immune boosting
SK bioscience said on Tuesday that it signed a research collaboration agreement with the Peter Doherty Institute for Infection and Immunity for global influenza prevention and response.The Doherty Institute, one of the world's top three sources of influenza strains, is affiliated with the University
Enhertu (trastuzumab deruxtecan or T-DXd), a next-generation antibody-drug conjugates (ADCs), has recently been listed in the Korean and European clinical treatment guidelines for Asians, winning recognition as a breast cancer treatment in Asian countries.The Korean Breast Cancer Society recently re
The global influenza vaccine market is experiencing a significant revival as the Covid-19 pandemic gradually subsides. The influenza virus, which causes seasonal flu, poses a significant threat each year, resulting in substantial morbidity and mortality globally.With Covid-19 now relatively under co
AstraZeneca's anti-CTLA-4 immunotherapy Imjudo (tremelimumab) has won approval from the Ministry of Food and Drug Safety for the first-line treatment of liver cancer, making the first dual immunotherapy available in Korea.The ministry on Friday approved Imjudo as the "first-line treatment of adult p
CHA Advanced Research Institute and CHA Biotech signed an agreement with GenKOre to develop gene therapeutics for sickle cell anemia and beta-thalassemia (β-thalassemia).Under the agreement, joint research combining CHA Biotech’s viral vector technology and GenKOre’s gene transfer technology will be
Celltrion and Jeil Health Science, which entrusted ICURE with the production of patch-type drugs, received a three-month administrative suspension of manufacturing operations due to ICURE's GMP violations.According to the Ministry of Food and Drug Safety, Celltrion and Jeil Health Science, an affili
SK bioscience , a Korean vaccine maker, said it has begun construction of its global research and process development (R&PD) center in Songdo, Incheon.The subsidiary of Korean conglomerate SK Group, plans to complete the construction of the R&PD center by the first half of 2025.Upon completion, the
While most CEOs would feel responsible for their company's financial condition, GeneOne Life Science CEO Park Young-geun is facing backlash for allegedly raising his salary while the company is losing money.GeneOne Life Science has been in a deficit for the past 18 consecutive years and retail inves
MSD's Keytruda (pembrolizumab) failed to demonstrate efficacy as perioperative adjuvant therapy in patients with operable locally progressive gastric and gastroesophageal junction adenocarcinoma.Global MSD, known as Merck in North America, on Tuesday (local time) unveiled the top-line results of the
Fine Investment Corp. is in advanced talks to acquire Boryung Biopharma for an undisclosed sum. The deal is expected to be announced soon, pending the completion of due diligence and negotiations over the purchase price.Fine Investment plans to acquire a 100 percent stake in Boryung Biopharma, inclu
Korean drug manufacturers are taking voluntary action by recalling or suspending the sales of tamsulosin, citing potential impurity concerns.Tamsulosin is a drug used to treat urination disorders such as benign prostatic hyperplasia (BPH). Astellas Korea's Harnal-D Cap. is the top-selling drug, and
SPASS, a Korean company specializing in artificial intelligence (AI) medical solutions, said its AI-based sepsis diagnosis solution, SpassageQ, has received FDA 510(k) clearance, also known as pre-market notification, local news reports said.The approval of the AI-based sepsis diagnosis software, Sp
SK bioscience said on Monday that it received WHO Emergency Use Listing (EUL) of its Covid-19 vaccine,SKYCovione.This makes SKYCovione the 12th Covid-19 vaccine granted an EUL by the World Health Organization (WHO). The WHO EUL is an assessment for listing three categories of medicines including vac
Bristol Myers Squibb (BMS) Korea held a press conference on Monday to celebrate the approval of Camzyos, an obstructive hypertrophic cardiomyopathy (oHCM) treatment, and highlight the clinical value of the EXPLORER-HCM trial, which led to the drug's approval.Camzyos is a treatment that selectively i