PharmAbcine, a developer of antibody drugs, said it has registered the first patient for a global phase-2 clinical trial on olinvacimab (TTAC-0001).In the U.S. and Australia, the phase-2 study will administer the investigational drug in incremental doses of 16, 20, and 24mg/kg to 23 patients with recurrent glioblastoma who do not respond to Avastin. The primary assessment will be monitorin
A lawmaker and physicians have voiced for enacting new legislation to contain the increasing number of patients with chronic kidney disease (CKD).Despite CKD’s high prevalence and incidence, complications and rising medical costs, the government provides no system for the prevention and management of the disease, experts said. Consequently, patients with CKD also suffer from financial difficul
Mezzion Pharma said its investigational drug udenafil improved exercise capacity in adolescents with congenital single ventricle heart disease (SVHD) in a global phase-3 trial.The latest data did not reach clinical significance in the traditional measurement, which evaluates the maximal oxygen consumption at the subject’s maximal effort (peak VO2), Still, it successfully achieved the oxygen co
Prosecutors have begun investigating local drug companies and distributors suspected of rigging bids in the government’s drug procurement projects.The Seoul Central District Prosecutors’ Office said Wednesday that its investigators raided more than 10 pharmaceutical manufacturers and distributors who are suspected of forming an illegal cartel to rig bids in a government tender for the procurem
Officials from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and local drug companies recently visited Ireland and Germany to learn how they nurtured biotech professionals and how Korean firms should enter the European market.The KPBMA delegation visited Ireland’s National Institute for Bioprocessing Research and Training (NIBRT), IDA (Industrial Development Authori
Samsung Bioepis said it was confident of achieving 1 trillion won ($855.8 million) global sales of biosimilars this year. The company also expected that it would generate an operating profit for the first time this year in its eight-year history. Samsung Bioepis CEO Ko Han-sung said the company’s accumulated sales in three quarters this year have already reached the level of the las
Amid the prosecution’s probe into Kolon Life Science’s osteoarthritis gene therapy Invossa-K, it is drawing attention whether the company could win U.S. approval to resume a trial on the drug.Industry watchers are watching whether the Food and Drug Administration (FDA) will allow the drug to contain kidney-derived cells (GP2-293 cells) that can potentially cause cancer.A former long-time F
The Catholic University of Korea Eunpyeong St. Mary’s Hospital said Tuesday it has built an artificial intelligence-based “Voice Electronic Nursing Record” (Voice ENR) system, which helps nurses to keep medical records using voice recognition.The hospital had a signboard hanging ceremony for its Voice Lab for EHR on Monday and demonstrated a speech-recognition nursing record system synchro
GX-I7, a new immunotherapy candidate being developed jointly by Genexine and its U.S. affiliated firm NeoimmuneTech, showed a longer half-life than an existing drug and strong stability even in high dose in a phase-1b study.The company released the interim results of the study for solid cancer patients at the annual meeting of the Society for Immunotherapy of Cancer (SITC 2019) in Maryland, th
Some cancer patients took a deworming medicine to cure their disease but suffered side effects, the Korean Society of Medical Oncology (KSMO) said. The group plans to collect similar cases and inform cancer patients about the risk of taking anthelmintic drugs.The controversy over the effectiveness of dewormers for cancer grew after a YouTube video claimed that a U.S. terminal cancer patient ac
Since the government started lung cancer screening in July, some experts have argued that it would not be effective. More recently, however, the Korean Association for Lung Cancer (KALC) rebutted the critics’ arguments one by one.KALC argued it was not true that “overdiagnosis would waste money and lung cancer screening provides insufficient evidence to reduce the mortality rate.” It then adde
A local court has refused to issue an arrest warrant against two executives of Kolon Life Science who were on charges of falsely reporting ingredient data to obtain approval for Invossa-K, an osteoarthritis gene therapy. The move is likely to cause a setback for prosecutors’ investigation.The Seoul Central District Court said on Monday the data submitted so far were not enough to explain the n
Three local pharmaceutical companies enjoyed robust growth in operating income in the third quarter, on the back of profits from licensing-out royalties, industry data showed. Along with the upfront payment, additional milestone payments raised their profits sharply.Yuhan Corp., Dong-A ST, and HanAll Biopharma recorded an earnings surprise, as their operating profit surged more than 100 percen
The prospect has once again dimmed for Kolon Life Science’s osteoarthritis gene therapy Invossa-K to survive in the market.A day before the pleading of the case of Kolon Life Science, which seeks to stop the government from nullifying the license of Invossa, prosecutors on Wednesday sought arrest warrant for two Kolon executives for submitting false data of the gene therapy.At the first pl
Prosecutors have sought arrest warrant for two executives of Kolon Life Science for submitting false data related to Invossa-K, the now-suspended osteoarthritis gene therapy.The move came five months after the Ministry of Food and Drug Safety filed a complaint against the company for breaching the Pharmaceutical Affairs Act, signaling that the prosecution is close to wrapping up its investigat
The Ministry of Food and Drug Safety said it would conduct a quality evaluation on all botulinum toxin (BTX) products, as Medytox was recently found to have exported unqualified Meditoxin goods.The ministry made public its plan while replying to the written inquiry during the National Assembly Health and Welfare Committee’s audit of the ministry.The committee member lawmakers Kim Soon-rye
Syntekabio, a new drug developer using artificial intelligence (AI)-based genome big data, said Thursday it passed the Korea Exchange’s preliminary review to be listed on the Kosdaq market. Earlier, two rating agencies gave the company an “A” rating in technology evaluation.Syntekabio said it would submit the registration statement to the Financial Services Commission as soon as possible
Pharmaceutical and biotech businesses have got together to strengthen their commitment to developing new drugs, as the industry faces both an opportunity and a crisis.The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) held a workshop for CEOs at Imperial Palace Hotel, Seoul, on Tuesday. Seventy-one heads of the member companies, including Yuhan Corp. CEO Lee Jung-hee, GC
Prosecutors demanded jail terms of one to four years for Samsung executives who were in trials for deleting data related to the alleged accounting fraud at Samsung BioLogics.At the last hearing held at the Seoul Central District Court on Monday, the prosecution sought four years for a vice president of Samsung Electronics, three years and six months for two vice presidents of the company’s bus
KangStem Biotech changed its strategy for Furestem-AD, an investigational stem cell therapy for atopic dermatitis, to use a repeated dosage after failing to prove the drug’s efficacy with a single dosage in a phase-3 trial. The change is likely to affect the company’s licensing-out deal currently under discussion. KangStem Biotech CEO Lee Tae-wha held an investor relations briefing