Hugel said Tuesday that it has won the first round of lawsuit against the head of the Seoul Food and Drug Safety Office to rescind the latter’s administrative order to revoke the license of its botulinum toxin product, Botulax, and stop its manufacturing and sales.On Feb. 8, the Seoul Administrative
Korea Pharma received the domestic bridging clinical study report (CSR) of its iron deficiency treatment, KP-01, and disclosed it on Monday.The bridge clinical trial of KP-01 was conducted in Korea after the Ministry of Food and Drug Safety approved the investigational new drug (IND) application in
AstraZeneca's third-generation EGFR TKI, Tagrisso (osimertinib), has demonstrated advanced efficacy in treating stage-3 non-small cell lung cancer (NSCLC) in the chemoradiotherapy (CRT) setting. EGFR TKI refers to epidermal growth factor receptor tyrosine kinase inhibitor.AstraZeneca said Monday, lo
GSK's shingles vaccine Shingrix is associated with an increased risk of herpes zoster ophthalmicus (HZO) recurrence, suggesting that patients with a history of the disease should be monitored closely after vaccination, a new study said.Last Thursday, local time, researchers from the University of Ca
HK inno.N's new drug for gastroesophageal reflux disease (GERD), K-CAB, has received marketing authorization in Chile.Through technology transfer or finished product exports, K-CAB has advanced to 18 Latin American countries. In about a year, it quickly achieved results in four countries: technology
ATGC has applied for the domestic approval of its new BTX product ATGC-110, or “Pure-Type Botaluma Injection (clostridium botulinum toxin type A, 150kDa),” for an indication that temporarily improves moderate to severe glabellar wrinkles.ATGC expects Botaluma to be Korea's third pure-type botulinum
Gilead's HIV treatment and prevention drug Truvada (emtricitabine/tenofovir disoproxil fumarate) has survived after a series of twists and turns in the Korean market.According to the minutes of the Central Pharmaceutical Deliberation Committee (CPDC) meeting released by the Ministry of Food and Drug
Daewoong Pharmaceutical said Monday it has established an “AI-based new drug development system,” which preprocesses and databases 800 million molecular models of major compounds that can be immediately utilized for drug development and discovers new drug candidates based on these materials.The comp
Celltrion said Monday that Health Canada has approved an additional indication for the company’s autoimmune disease treatment Remsima SC (infliximab) -- Zymfentra in the U.S. -- for inflammatory bowel disease (IBD).IBD is a chronic, incurable intestinal disease in which the immune system targets the
In recent years, Korea's market for pediatric growth hormone treatments has witnessed a significant surge, with non-reimbursable treatments accounting for 90 percent of the total prescriptions. According to IQVIA, a drug market research firm, the pediatric growth hormone treatment market grew to 238
Hanmi Pharm and GC Biopharma have gotten on track to develop a new treatment for Fabry disease with longer-lasting effects than existing treatments.Hanmi Pharm and GC Biopharma presented two posters on the results of nonclinical studies of LA-GLA (code name HM15421/GC1134A), a candidate for Fabry di
Daewoong Pharmaceutical's Fexuclue is expanding globally as fast as it is effective.Daewoong said Friday that its gastroesophageal reflux disease (GERD) treatment, Fexuclue, has entered or is about to enter the market in 24 countries, including Korea, in just one year and six months since its launch
JW Pharmaceutical said Wednesday that the U.S. Drug Safety Monitoring Board (DSMB) has positively reviewed top-line results from its multinational phase 3 clinical trial of Epaminurad (codenamed URC102) for gout and recommended continuing the trial.On Jan. 31, the DSMB, comprised of U.S. rheumatolog
The management conflict between Hanmi Science, the Hanmi Pharmaceutical Group holding company, and Lim Jong-yoon, the eldest son of the late founder and president of Hanmi Pharmaceutical, is deepening.After Hanmi Science criticized Lim, the latter hit back."Hanmi Pharm's public relations team claims
Celltrion is expanding its market presence in Peru, a key Latin American market, with successful public tender wins.Celltrion’s Truxima 500mg (rituximab) won the tender for the Peruvian Ministry of Health (Centro Nacional de Abastecimiento de Recursos Estratégicos en Salud, CENARES), the largest pub
Dong-A ST and IMBiologics said they have entered into a research collaboration agreement to develop a novel antibody drug candidate.The collaboration involves IMBiologics deploying its ePENDY (enhanced/engineered Pentamer body) platform technology.Unlike the conventional IgG antibody-based modalitie
Sanofi-Aventis Korea has extended the expiration date of its hemophilia A treatment Eloctate (efmoroctocog alfa) in Korea, following a controversy over mislabeling the drug's expiration date.Sanofi said Wednesday that it has received approval from the Ministry of Food and Drug Safety (MFSD) to exten
New drugs with different mechanisms of action have recently entered the ulcerative colitis (UC) treatment market in Korea, heralding fierce competition.Last Friday, the Ministry of Food and Drug Safety (MFDS) approved Lilly's interleukin-23 (IL-23) inhibitor Omvoh (mirikizumab), giving Korean patien
SK chemicals said that it has decided not to proceed with the sale of its pharmaceutical business unit despite having previously signed a non-binding memorandum of understanding (MOU) with Glanwood Private Equity.SK chemicals' business divisions are divided into green chemicals, which produces eco-f
Huons' sales exceeded 500 billion won ($375 million) last year, thanks to increased pharmaceutical exports and efficient management of sales and management expenses.In a public filing on Wednesday, the company disclosed its preliminary consolidated operating results for 2023.According to the disclos