Shares of VUNO shot up by around 11 percent on Thursday morning after the company announced that its AI-based cardiac arrest prediction medical device, VUNO Med-DeepCARS, has been designated as an innovative medical device by the U.S. FDA, the first in the Korean medical AI industry. As of 11:11 a.m
Samsung Biologics and Pfizer said they signed a $411.3 million long-term agreement for Samsung Biologics to manufacture Pfizer’s pharmaceutical products. The companies did not disclose the duration of the "long-term" contract.The latest contract is Samsung Biologics' largest partnership agreement si
Matica Biotechnology, a U.S. subsidiary of CHA Biotech, unveiled its new MatiMax cell lines at the 2023 BIO International Convention (BIO 2023), hoping that it could boost cell and gene therapy (CGT) CDMO contracts.The new GMP-grade cell lines outperform industry standards and enable rapid growth pe
Kainos Medicine said on Wednesday that the phase 3 clinical trial results of its HIV/AIDS treatment, KM-023 (ingredient: ainuovirine), which demonstrated excellent safety and efficacy was published in one of the world's leading medical journals.KM-023 is a next-generation non-nucleoside reverse tran
CHICAGO, Ill. -- By Kim Yun-mi/Korea Biomedical Review correspondent -- "The ADAURA study is the first global phase 3 trial to demonstrate a statistically significant and clinically meaningful overall survival (OS) benefit with targeted therapy in patients with resected stage 1B to 3A EGFR-mutated n
Celltrion said on Monday that it signed an agreement with U.S.-based biotech, Rani Therapeutics, to develop an oral formulation of RT-105 (ingredient: adalimumab), a treatment for autoimmune diseases.Accordingly, Celltrion will exclusively supply Rani with an oral adalimumab formulation and will hav
CHICAGO, Ill. -- By Kim Yun-mi/Korea Biomedical Review correspondent -- The annual meeting of the American Society of Clinical Oncology (ASCO 2023), the world's largest cancer conference, has successfully returned to full strength following a temporary pause during the Covid-19 pandemic. Packed with
Daewoong Pharmaceutical said on Monday that it terminated the exclusive license agreement with Neurogastrx initially intended for the clinical development and commercialization of Fexuclue (ingredient: fexuprazan) in the U.S. and Canada.Fexuclue is Daewoong Pharmaceutical’s gastroesophageal reflux d
HLB Science, which is developing a next-generation sepsis treatment, said on Friday that it signed a research agreement with NodCure, a company that has the technology to develop microbiome-based therapeutics for metabolic and immune diseases.Through this agreement, HLB Science will conduct joint re
Starting this month, Janssen's psoriasis treatment, Tremfya (ingredient: guselkumab), will be covered by the national health insurance for patients in Korea with palmoplantar pustulosis (PPP) treated with methotrexate or cyclosporine.Previously, Tremfya was only covered for patients with PPP treated
The Ministry of Food and Drug Safety (MFDS) said on Friday that it initiated administrative penalties and recall and destruction procedures against Huons BioPharma for the unauthorized sale of its botulinum toxin (BTX) Liztox Inj. 100 units without obtaining domestic export approval.The penalty incl
The nation’s health insurance review agency said Roche's Evrysdi (risdiplam), an oral treatment for spinal muscular atrophy (SMA), was deemed eligible for reimbursement. The decision came more than two years after Roche’s application.The Health Insurance Review and Assessment Service (HIRA) held the
Yuhan Corp. said on Tuesday it signed a licensing-in agreement with J INTS BIO for its HER2-targeting tyrosine kinase inhibitor (TKI), JIN-A04, to work on a treatment for non-small cell lung cancer (NSCLC).The total value of the agreement is 429.8 billion won (approximately $324.9 million), includin
NeoImmuneTech announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), a division of the U.S. National Institutes of Health (NIH), has commenced a nonclinical trial to evaluate the efficacy of NT-I7 in treating acute radiation syndrome (ARS).In December 2022, NeoimmuneT
CrystalGenomics said on Thursday that its partner Jiangsu Hengrui Pharmaceuticals submitted a biological license application (BLA) to the FDA on Wednesday for approval of camrelizumab in combination with apatinib as a first-line treatment for liver cancer.The BLA was submitted through Jiangsu Hengru
GC said it has received final approval from the Indonesian Ministry of Health and Welfare to build a blood products plant in the country and transfer technology. The company has yet to disclose the location of the plant.The Indonesian government had been selecting companies for the construction and
BMS Korea has announced that Inrebic (ingredient: fedratinib), its myelofibrosis drug, will now be covered by the national health insurance system in Korea starting from June 1.Inrebic is a second-line treatment for myelofibrosis that selectively inhibits the JAK2 gene mutation, and can help improve
HLB will be the newest member of the KRX300 Healthcare Index on the Korea Exchange (KRX) on June 9.The anticancer drug developer said Wednesday that it would be included in the KRX300 Healthcare Index next Friday when the KRX regularly changes its index.HLB was not included in the Healthcare Index b
SCM Lifescience, a company specializing in the research and development of cell therapies, said on Tuesday that its stem cell therapy for atopic dermatitis, SCM-AGH, demonstrated efficacy and safety in phase 2 clinical trials.The phase 2 study was conducted on 72 patients with moderate or severe ato
AbbVie Korea is strengthening its position in the local adolescent atopic dermatitis market with Rinvoq (ingredient: upadacitinib), a treatment for moderate to severe atopic dermatitis armed with new reimbursement benefits, the company said Tuesday.Rinvoq received expanded to include coverage for th