Pfizer won a patent lawsuit against local drugmakers over its antismoking drug Champix on Friday. With the ruling, the domestic manufacturers will find it almost impossible to roll out their generic copies by changing the base of the drug to avoid Pfizer’s substance patent. The Intellectual Property Trial and Appeal Board (IPTAB) ruled that it would reverse its earlier decision on 20 Korea
Kolon Life Science is working flat out to prove the safety of Invossa-K, the revoked gene therapy due to an ingredient mislabeling, in its legal fight against the government.The company brought foreign experts as witnesses to the court and claimed that the ongoing prosecution’s probe revealed the treatment had no safety concerns.The Seoul Administrative Court on Thursday held the second pl
The government said it has allowed four companies, including Theragen Etex and Eone Diagnomics Genome Center (EDGC), to provide up to 56 direct-to-consumer (DTC) genetic testing services.The presidential National Bioethics Committee decided so at a meeting on Wednesday to review the result of the pilot project for the DTC genetic testing service certification system and discuss measures to enh
QuantaMatrix, an in-vitro microbial diagnostic solution developer, has passed the Korea Exchange’s technology evaluation to go public on the Kosdaq market. The company is aiming to be listed under the financial regulator’s “technology exception policy.”The diagnostics company said Wednesday it passed the technology review after receiving A-rating from both Korea Technology Finance Corporation
Small and mid-size domestic companies are rushing to develop botulinum toxin products, and four of them won approvals to conduct clinical trials for new anti-wrinkle treatments this year.Ini Bio said Tuesday the Ministry of Food and Drug Safety gave the go-ahead to phase-1/2 trial on its botulinum toxin, INI-101. The study will compare the safety and efficacy of INI101 and botox strains in im
Despite disappointing clinical trial failures by major biotech firms, venture capital investment in the biotech and medical sector is likely to hit a record high this year, industry data showed.Compared to a year earlier, this year’s gain may have slowed, but venture capital investment in the biotech industry is expected to surpass 1 trillion won ($858.7 million) in 2019 owing to various attem
Helixmith said it would announce next month the cause of the data error in its global phase-3 trial on Engensis (VM202-DPN), a gene therapy to treat diabetic peripheral neuropathy (DPN).Earlier, the company said the failure resulted from its drug mix-up between the placebo and the treatment.Now, it is also weighing other possibilities, such as technical errors. Helixmith CEO
Yuhan Corp. said it would start a phase-3 global study to evaluate the efficacy of Lazertinib (YH25448) as the first-line treatment for non-small cell lung cancer (NSCLC).The company received approval from the Ministry of Food and Drug Safety on Wednesday to go ahead with the phase-3 trial.The study aims to confirm the safety and efficacy of Lazertinib as the first-line treatment in NSCLC.
Aprogen has joined the list of unicorn companies, as the first Korean biotech firm.CB Insights, a U.S. market research firm, gave the unicorn status to Aprogen on Monday. A unicorn company refers to a firm with a valuation of over $1 billion before going public.Aprogen attracted 20 billion won ($16.7 million) investment from Lindeman Asia Investment in May, which led its valuation to surpa
A Seoul court gave jail terms to Samsung executives for destroying evidence in an investigation of alleged accounting fraud at Samsung BioLogics. However, the ruling had nothing to do with whether they were guilty or not of the alleged accounting fraud, the court noted.The Seoul Central District Court on Monday said all of the eight Samsung executives and officials were guilty of plotting toge
SK Biopharmaceuticals said it would begin to develop a second new drug for epilepsy to solidify its status in the epilepsy treatment market and specialize in central nervous system diseases.The company said Tuesday the U.S. Food and Drug Administration gave the green light for investigational new drug (IND) application for SKL24721, a drug candidate for epilepsy treatment.The company will
Samyang Biopharm USA said Tuesday it has signed a deal to adopt a new immunotherapy candidate from U.S. biotech firm CanCure. Samyang Biopharm USA is a U.S. subsidiary of Samyang Biopharmaceuticals, a biomedical unit of Samyang Group.Under the agreement, Samyang Biopharm USA will hold the globally exclusive right to develop, manufacture, and commercialize the new drug candidate SYB-010, de
Alteogen, a biotech firm, said it has successfully concluded a deal to make profits out of its own platform technology.The company said Friday it signed a non-exclusive global license agreement with one of the top 10 pharmaceutical companies for the human hyaluronidase (ALT-B4) platform technology. Under the agreement, Alteogen will provide ALT-B4, and the partner company will develop and comm
Daewoong Pharmaceutical said its new drug Fexuprazan will challenge the potassium-competitive acid blocker (P-CAB) market, dominated by CJ HealthCare’s K-Cab.Pharmaceutical industry sources said Friday Daewoong has completed phase-3 trials on Fexuprazan and applied for marketing approval this month.P-CAB is regarded as the next-generation medicine to replace proton pump inhibitors (PPI), o
SK Chemicals said Thursday it has won local marketing license for Ongentys (ingredient: opicapone), a Parkinson’s disease treatment developed by Portuguese drugmaker Bial. The two companies signed an agreement in February 2018 to supply Ongentys exclusively in the Korean market. The first Parkinson’s disease treatment in the local market is to be released in the second half of 2020.
A Seoul court issued an arrest warrant for an executive at Kolon Life Science, who was involved in the development of suspended osteoarthritis gene therapy Invossa-K. Another exec managed to avoid the arrest. The Seoul Central District Court issued the arrest warrant for the head of the Clinical Development Team at Kolon Life Science, surnamed Cho, at around 0:30 a.m. on Thursday. The decision
SK Chemicals said it has obtained approval from the U.S. Food and Drug Administration for SID710, a patch-type medicine for Alzheimer’s disease, on Wednesday. SID710 is a generic copy of Novartis’ Exelon and the first to win the FDA nod among locally developed patch for dementia. SID710 can be attached to the skin once a day, as dementia patients have difficulty remembering the time and th
Roche Diagnostics Korea rolled out NAVIFY Tumor Board, a data integration platform that helps doctors review cancer cases more efficiently and make more accurate treatment decisions for patients.The company held a news conference at a hotel in Seoul, Wednesday, to promote the newest application.A tumor board is a decision-making process by a group of doctors in each field including oncolog
“We will build big data through Korean Precision Medicine Networking Group (K-PM), a group for collaboration among researchers at hospitals, and expand opportunities for patients for better treatment access through the K-MASTER program. In this way, we will use precision medicine to fight cancer.”The Korean Society of Medical Oncology (KSMO) made this and other points to show its commitment to
Vivozon, a privately held biopharmaceutical firm on the over-the-counter (OTC) market, is to become the largest shareholder of Kosdaq-listed Lumimicro.Vivozon’s move might signal that it is seeking backdoor listing, observers said. Backdoor listing is an easy way to get onto a stock exchange without an initial public offering.Lumimicro said in a public filing on Tuesday that it signed an a