Liveome, an affiliate of Medytox, said it completed the phase 1 clinical trial in Australia for its gene-recombinant microbiome drug, LIV001.The drug is being developed as a treatment for inflammatory bowel disease, a chronic immune disorder that has been challenging to manage with existing therapie
HK inno.N is embroiled in a crisis rumor after it lost the first round of patent litigation for the crystalline form of its P-CAB-based gastroesophageal reflux disease (GERD) drug, K-CAB Tab (tegoprazan).However, the company denied such concerns, expressing confidence about the continued growth of K
"Korea is known for its successful clinical trials. However, underneath it is Korea’s characteristics of frequently delayed reimbursement for new drugs. I think part of it is to ensure access to new drugs by participating in clinical trials."Ingrid A. Mayer, vice president of global clinical strateg
Korean pharmaceutical and biotechnology companies are set to present their latest studies at the American Association for Cancer Research (AACR) Annual Meeting 2024.The AACR meeting, established in 1907 and regarded as one of the world's top three cancer conferences alongside those of the American S
Hanmi Pharmaceutical said it has submitted an investigational new drug (IND) application for a phase 1 clinical trial of its obesity treatment candidate HM15275 to the Ministry of Food and Drug Safety (MFDS). Hanmi also plans to submit the IND application to the U.S. FDA this month.HM15275 is an obe
ST Pharm and LegoChem Biosciences have entered into a contract for joint research and manufacturing of antibody drug conjugate (ADC) linkers.Under the accord, ST Pharm plans to provide contract development and manufacturing organization (CDMO) services covering the entire production process based on
MSD's anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been approved for the first-line treatment of HER2-negative gastric cancer following BMS’s Opdivo (nivolumab).MSD Korea said Monday that Keytruda received approval from the Ministry of Food and Drug Safety (MFDS) last Wednesday for an expand
GSK's Jemperli (dostarlimab) has secured the first-line treatment indication for endometrial cancer ahead of MSD's Keytruda (pembrolizumab), becoming the first immunotherapy in Korea to be approved for both first- and second-line treatment.GSK Korea said its endometrial cancer drug Jemperli had rece
SK chemicals has received a series of positive ratings from global rating agencies. Notably, the company’s MSCI ratings have been on an upward curve.SK chemicals said Monday that it received an overall AA rating in the 2023 ESG (Environment, Social and Governance) assessment conducted by Morgan Stan
Sanofi Pasteur Korea said it received marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its invasive meningococcal vaccine, MenQuadfi (meningococcal (A, C, Y, W) polysaccharide-TT protein conjugate vaccine) on Wednesday last week.MenQuadfi is a fully liquid vial quadrivale
Daehwa Pharm, a Kosdaq-listed drugmaker, said Friday it received orphan drug designation (ODD) from the European Medicines Agency (EMA) for Liporaxel Solution, an oral paclitaxel, for the second-line treatment of gastric cancer on Feb. 26.Daehwa explained that the orphan drug designation for Liporax
GC Medical Science (GC MS) said Friday that it has signed an agreement for the long-term supply of hemodialysis solutions with Baxter Korea’s Kidney Business Division.GC MS has supplied hemodialysis solutions to Baxter for the past five years, from 2019 to 2023. With the latest agreement, GC MS will
Genexine and Handok said Friday that GX-H9 (HL2356), a long-acting growth hormone for pediatric use under co-development by the two, has been designated as an orphan drug in the developmental stage by the Ministry of Food and Drug Safety (MFDS).According to the companies, the designation of GX-H9 as
Medytox posted a significant year-over-year drop in profits last year. The company attributed it to ongoing litigation and other reasons while predicting its performance will improve this year.On Thursday, Medytox released its preliminary consolidated operating results for 2023 through a public disc
The second-generation bruton tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), developed by BeiGene, has cleared the threshold of the Pharmaceutical Reimbursement Evaluation Committee (PREC) after a second attempt at expanded coverage.At the same meeting, AstraZeneca's asthma drug Fasenra (be
Samsung Pharm has received approval from the Ministry of Food and Drug Safety (MFDS) to change the investigative new drug (IND) application for its phase 3 clinical trial of GV1001 for Alzheimer's disease.The MFDS accepted Samsung Pharm's application to simplify GV1001's dosing regimen, approving a
In a significant milestone marking the ten-year collaboration between SK bioscience and Sanofi, a global leader in healthcare, the two companies have embarked on an ambitious expansion of the L HOUSE, SK bioscience’s vaccine manufacturing plant in Andong, North Gyeongsang Province.This expansion aim
HLB Group has announced the acquisition of domestic rights to Jiangsu Hengrui Pharmaceuticals' immunotherapy, camrelizumab, facilitating the path towards commercializing the combination therapy of camrelizumab and its novel drug candidate riboceranib in Korea.The group's subsidiaries -- HLB Life Sci
Binex, a Kosdaq-listed biopharmaceutical CDMO, has been subjected to a two-month suspension of sales operations for Bimo 5mg (ingredient: minoxidil), a hair loss treatment, for failing to submit necessary documents for the 2023 drug equivalence reevaluation.The product in question will not be availa
MSD's 15-valent pneumococcal conjugate vaccine (PCV), Vaxneuvance, will be used in Korea in earnest next month as part of the government’s pediatric national immunization program (NIP).MSD Korea said it had secured sufficient batches of Vaxneuvance to prepare for its full-scale launch.Vaxneuvance is