The first FGFR inhibitor for bladder cancer, Balversa (erdafitinib), will soon be launched in Korea.According to industry sources on Monday, Janssen Korea is gearing up to release Balversa without reimbursement in late March.Balversa is an FGFR (fibroblast growth factor receptor) inhibitor approved
Celltrion once again demonstrated the competitiveness of its Remsima SC at the 2024 European Crohn's and Colitis Organization (ECCO) congress in Stockholm, Sweden, from last Wednesday to Saturday by receiving favorable reviews from overseas medical professionals.At the ECCO, attended by more than 8,
GC Cell has signed an agreement to transfer the processing technology of its flagship anticancer immune cell therapy, Immuncell-LC Injection, to BioCentriq, its U.S. affiliate, and a cell therapy CDMO company.Through this process technology transfer cooperation, GC Cell and Biocentriq expect to prov
JW Shinyak said Monday it has signed a collaborative research agreement with C&C Research Laboratories, a subsidiary of JW Pharmaceutical, to develop innovative anticancer cell therapies.Under the agreement, JW Shinyak will develop a new CAR-NK cell therapy targeting solid tumors with C&C Research L
CKD Bio said it has confirmed the non-inferiority of CKDB-501A, aimed at improving moderate to severe frown lines, compared to Botox through a phase 3 clinical trial's topline results.The analysis of the data revealed that the improvement rate for frown lines when frowning was 80.69 percent (117 out
LG Chem said Friday that the company opened an aesthetic “Solution Lab Center" in Caiting Hospital, which specializes in cosmetic surgery in Shanghai, to expand expand its educational support for YVOIRE (LG Chem's hyaluronic acid filler’s brand name) customers in China.LG Chem’s Executive Vice Presi
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