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
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
Celltrion said Tuesday it confirmed interchangeability between Yuflyma (adalimumab), an autoimmune disease biosimilar, and the original drug AbbVie’s Humira, in a global phase 3 psoriasis clinical trial.Based on the clinical results, Celltrion plans to get approval from the U.S. FDA for the intercha
In an extraordinary year for the Korean pharmaceutical and biotech industry, the sector has achieved a new milestone with 14 companies successfully finalizing 17 technology export deals, showcasing its growing global presence and innovative capabilities.The 14 companies include, Daewoong Pharmaceuti
Eagle Vet, an animal pharmaceutical company, said Friday that it signed a contract manufacturing organization (CMO) agreement with Orion, a Finnish pharmaceutical company, to supply Oriverm (ivermectin), an animal anthelmintic injection.It took six years for Eagle Vet to select the product to be sup
AstraZeneca Korea has received marketing authorization for Tezspire (tezepelumab), a treatment for severe asthma in Korea.The Ministry of Food and Drug Safety (MFDS) approved Tezpire on Thursday.Tezspire is an anti-TSLP monoclonal antibody that binds to thymic stromal lymphopoietin (TSLP), which cau
Yuhan Corp.’s lung cancer treatment Leclaza (lazertinib) has made the first step into the global pharmaceutical market as a Korean-made anticancer drug. On Thursday, Janssen Pharmaceuticals, a pharmaceutical company wholly-owned by Johnson & Johnson, said that it submitted a marketing authorization
From Jan. 1, AstraZeneca's Tagrisso (osimertinib) and Yuhan Corp.'s Leclaza (lazertinib) will get health insurance coveraget for the first-line treatment of locally advanced and metastatic non-small cell lung cancer (NSCLC).Koselugo (selumetinib), developed by AstraZeneca and MSD, will be also cover
Keytruda (pembrolizumab), MSD's anti-PD-1cancer immunotherapy, has received approval for two additional indications in Korea.MSD Korea said Keytruda received the permit from the Ministry of Food and Drug Safety (MFDS) as a first-line treatment in adult patients with HER2-positive advanced gastric ca
The Korean ankylosing spondylitis treatment market is at a significant turning point thanks to the expansion of health insurance benefits for related drugs, an expert said. Ankylosing spondylitis, if left untreated, can lead to a hunched back and stiff neck. Typically, the disease begins with altern
Boryung and HK inno.N have entered into an agreement for the joint marketing of their flagship drugs, Kanarb (pimasartan) and K-CAB (tegoprazan), starting January next year. Under this collaboration, Boryung will jointly market HK inno.N's K-CAB Tab and K-CAB ODT, while HK inno.N will jointly market
LG Chem, which is developing a gout treatment, has taken a step closer to global clinical trials in Europe.LG Chem said in a public filing on Tuesday that the company has received conditional approval from the Italian regulator Agenzia Italiana del Farmaco (AIFA) for a phase 3 clinical trial (EURELI
Dong-A ST said Wednesday that it has acquired AbTis, a company specializing in antibody drug conjugate (ADC).Dong-A ST did not disclose an acquisition cost for the deal.AbTis has developed AbClick, an ADC technology that can site-selectively conjugate drugs without antibody modification.ADC is an an
Bristol Myer Squibb (BMS)’s Camzyos has emerged as a groundbreaking treatment for obstructive hypertrophic cardiomyopathy (oHCM), a rare disease in which the muscle in the pumping chamber of the heart becomes thickened, an expert said in an interview with Korea Biomedical Review. Until now, the only
Daewoong Pharmaceutical and Medytox are set to compete in the submental fat improvement injectable market, following botulinum toxin (BTX).Medytox said it applied for a new prdoduct license from the Ministry of Food and Drug Safety for NEWV (MT921 in development name), a lipolysis injection with the
PharmaEssentia's Besremi (ropeginterferon alfa-2b), a treatment for polycythemia vera (PV), showcased exceptional therapeutic efficacy, achieving complete hematologic and molecular biologic responses in Korean patients who did not respond to hydroxyurea therapy, a study showed. Professor Lee Sung-eu
HLB, a Kosdaq-listed anticancer drug developer, said that the combination of the targeted therapy rivoceranib and immunotherapy camrelizumab has proved effective not only in hepatocellular carcinoma (HCC) but also in lung cancer in a phase 2 clinical trial.HLB reported that Jiangsu Hengrui Pharmaceu
Gemvax & Kael, a Kosdaq-listed peptide drug specialist, said on Tuesday that it has submitted a phase 2 investigational new drug (IND) application to the U.S. FDA for GV1001, targeting the treatment of progressive supranuclear palsy (PSP).PSP is an atypical Parkinson's syndrome characterized by rapi