GC Cell said that its U.S. affiliate, Artiva Biotherapeutics, has received fast-track designation from the U.S. FDA for their investigational lupus nephritis treatment, AlloNK (development code name: AB-101).The fast track designation is intended to facilitate the development and expedite the review
AbbVie's oral migraine prophylaxis Aquipta (atogepant) met its primary endpoint in a phase 3 clinical trial of patients who failed prior oral prophylaxis, reducing the average number of migraine days per month.AbbVie Korea said Friday that the full results of the phase 3 ELEVATE study were published
A typhoid conjugate vaccine developed by SK bioscience has received the World Health Organization's (WHO) Pre-Qualification (PQ) certification, a green light to enter new overseas markets.SK bioscience said Friday that its typhoid conjugate vaccine, SKYTyphoid Multi-Injection (NBP618 in the project
Janssen has been delaying the Korean launch of its FGFR (fibroblast growth factor receptor) inhibitor Balversa (erdafitinib) for over a year, making many watchers wonder what's happening.Janssen received approval for Balversa on Nov. 24, 2022, from the Ministry of Food and Drug Safety (MFDS).Balvers
At a government-business meeting early this week, the Ministry of Food and Drug Safety (MFDS) announced its intention to support exporting Korean medical products based on regulatory harmonization. Welcoming the move, pharmaceutical companies made several requests to open the way for exporting their
The Korea Research-based Pharmaceutical Industry Association (KRPIA) announced that it has appointed Bae Kyung-eun, General Manager of Sanofi-Aventis Korea, as the 15th chairperson of the association.This decision was made during the association's board meeting, marking a new chapter in KRPIA's lead
Genuv, an innovative drug discovery venture, has been selected to receive funding from the Alzheimer's Drug Discovery Foundation (ADDF) in the United States.The ADDF, supported by the Estée Lauder family and the Bill & Melinda Gates Foundation, selects Alzheimer's projects worldwide based on their t
Dongkook Pharmaceutical said it signed a memorandum of understanding with Oncovix to commercialize functional materials at its headquarters office in Cheongdam-dong, southern Seoul, last Friday.Through this agreement, the two companies will jointly develop new drugs with antibacterial and anti-infla
Korean medical experts have welcomed the introduction of Pfizer’s Zavicefta (ingredient: ceftazidime/avibactam), a new antibiotic treatment for infections caused by multi-drug resistant organisms, including carbapenem-resistant Enterobacteriaceae (CRE).During a press conference organized by Pfizer K
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