Medytox, a Korean botulinum toxin (BTX) maker, said it has established a U.S. subsidiary Luvantas to advance into the global market with MT10109L, its non-animal-derived liquid BTX formulation.The company had submitted a biologics license application (BLA) for MT10109L to the FDA in late December. T
MedPacto, a Korean immunotherapy developer, said Wednesday that the U.S. FDA has approved a phase 2b/3 investigational new drug (IND) plan for the combination of its immunotherapy, vactosertib, and MSD’s Keytruda (pembrolizumab), in patients with metastatic colorectal cancer.For phase 2b/3 study, Me
In their New Year's messages on Tuesday, major Korean pharmaceutical companies praised their employees for their hard work in overcoming crises, such as Covid-19 and the economic downturn, and expressed their determination to become global pharmaceutical companies by developing innovative new drugs.
Kolon Life Science said Wednesday that its patent on alleviating or treating pain for neuropathic pain gene therapy, KLS-2031, and a patent on a recombinant vaccinia virus for anti-cancer gene therapy, KLS-3021, won registration in India.KLS-2031 features a recombinant adeno-associated virus (rAAV)
Helixmith said its gene therapy Engensis, also known as VM202-DPN, failed to meet the primary endpoint in a phase 3 clinical trial for treating diabetic peripheral neuropathy (DPN) conducted in the U.S.The phase 3 DPN trial was divided into two studies, 3-2 and 3-2b, where the primary endpoint invol
NKMAX, a Korean natural killer (NK) cell-based immunotherapy company, said Tuesday that its U.S. affiliate, NKGen Biotech, has completed dosing the first patient in its phase 1/2a Alzheimer's disease clinical trial of SNK01, an NK cell therapy for Alzheimer’s disease, in the U.S.In October last year
The Celltrion Group on Tuesday announced the divestiture of primary care business rights in the Asia-Pacific acquired from Takeda Pharmaceutical in 2020, excluding domestic ethical drugs (ETC).In 2020, Celltrion acquired the business rights in the Asia-Pacific region for 18 brands of Takeda Pharmace
When couples consider initial gifts to celebrate the arrival of a new baby, they commonly think of umbilical cord stamps, or hand and foot sculptures. However, capturing a photo of the fundus, the clear inner part of the child's eye, could be more crucial because detecting congenital eye diseases in
BL Pharmtech, a Kosdaq-listed health functional food company, said Friday that it has completed the sale of its subsidiary, BL Healthcare, to Kwangdong Pharmaceutical.BL Healthcare specializes in health functional foods and is engaged in bio-new material research and functional cosmetics business.On
Sanofi-Aventis Korea has initiated a voluntary recall of some batches of Eloctate (efmoroctocog alfa), a hemophilia A treatment, from the Korean market.According to the Ministry of Food and Drug Safety, the company has recently filed a recall plan for specific batches of Eloctate (250 IU, 1000 IU) w
Nearly 30 percent of pharmaceutical companies and medical device makers provided economic benefits for medical workers in 2022.According to the fact-finding survey, 27.7 percent of these businesses provided 20.47 million products worth 880.7 billion won ($682.1/1 million) for doctors, nurses, pharma
Yuhan Corp. said Thursday that Leclaza (lazertinib mesylate monohydrate), a treatment for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), will receive insurance benefits for the first-line treatment starting Jan. 1, 2024.The coverage expansion will allow
Qurient, a company specializing in developing anticancer drugs, has become the first to receive investment from the government-led K-Bio and Vaccine Fund.Qurient said the payment of 3.5 billion won ($2.7 million) in perpetual convertible bonds by the Premier IBK K-Bio Vaccine Investment Fund was com
The year 2023 marked significant transformations in the medical and pharmaceutical sectors. Despite facing resistance from the medical community, President Yoon Suk Yeol's administration declared its intention to increase the number of medical school seats starting in 2025. Additionally, 2023 witnes
Medytox said it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for MT10109L, a non-animal-derived liquid botulinum toxin (BTX) formulation indicated for improving moderate to severe frown lines and crow's feet.The submission follows Medytox's completion
Ildong Pharmaceutical has shifted its strategy toward manufacturing Xocova (ensitrelvir fumaric acid; S-217622 in development name), a Covid-19 treatment it co-developed with Japan’s Shionogi, from importing it.Ildong said Wednesday that it applied for a manufacturing and sales license for Xocoba to
Celltrion said Wednesday that it has completed the submission of its marketing authorization application for its Xolair (omalizumab) biosimilar, CT-P39, to Health Canada.The application is based on results from Celltrion's global phase 3 clinical trial of CT-P39, which enrolled a total of 619 patien
EuBiologics, a Kosdaq-listed vaccine development company, said Tuesday that it has received an export license for Euvichol-S, a reformulated oral cholera vaccine, from the Ministry of Food and Drug Safety (MFDS).Euvichol-S was developed in collaboration with the International Vaccine Institute (IVI)
LegoChem Biosciences, a Kosdaq-listed drug development company, said Tuesday that it signed a technology transfer agreement with Janssen Pharmaceuticals, a pharmaceutical company wholly owned by Johnson & Johnson, for the development and commercialization of LCB84, antibody-drug conjugate (ADC) cand