Medicine and medical equipment makers from Korea and Japan gathered to discuss their cooperative growth, holding the 4th Korea-Japan Joint Symposium on Medical Products at COEX in Seoul Tuesday. The symposium was jointly organized by regulators of both countries -- Korea’s Ministry of Food and Drug Safety and Japan’s Ministry of Health, Labour and Welfare. Also helping to hold the event were K
The Ministry of Food and Drug Safety said it would conduct a comprehensive investigation on Medytox over several suspicions raised by a local broadcaster. However, industry watchers questioned the probe would yield meaningful results because the company had already scrapped related data.The public broadcaster KBS has recently reported that Medytox allegedly had a quality control problem an
Colon cancer specialists questioned SillaJen’s allegation that the combination of SillaJen’s Pexa-Vec and AstraZeneca’s Imfinzi worked well in colorectal cancer patients who did not respond to immune checkpoint inhibitors.SillaJen said on Wednesday that in a trial sponsored by the U.S. National Cancer Institute (NCI) on the combo therapy of Pexa-Vec and Imfinzi, one patient with microsatellite
The Seoul Administrative Court on Thursday said it has temporarily suspended its decision until July 29 on whether to stop the drug regulator’s order to nullify the license of Kolon Life Science’s gene therapy Invossa-K.On the same day, the Daejeon District Court also delayed a ruling on the Daejeon Food and Drug Safety Administration’s order to recall and dispose of Invossa injections until J
The prosecution raided two securities firms that managed the initial public offering of Kolon TissueGene in 2017, to know whether the two had known about the mislabeling of the now-suspended gene therapy Invossa-K before listing. According to industry sources, the Criminal Affairs Division 2 of the Seoul Central District Prosecutors’ Office swooped on NH Investment & Securities and Korea Inves
“Seeking NASDAQ listing as soon as possible, we will show the excellent efficacy of ‘Super NK (Natural Killer)’ cell therapy in the global market.”So said Park Sang-woo, CEO of NKMax, at an investor relations briefing in Yeouido, Seoul, Tuesday, announcing the plan for NKMax America, a U.S. subsidiary, to go public on the U.S. stock exchange. While many other developers of cell-
Contera Pharma, a Copenhagen-based subsidiary of Korean drugmaker Bukwang Pharm, said it has raised 3 billion won ($2.5 million) investment from Medici Investment, a venture capital firm in Seoul.Contera Pharma plans to use the fund to speed up a phase-3 trial on JM-010, a treatment candidate for levodopa-induced dyskinesia (LID) in Parkinson’s disease, in Europe.Bukwang acquired Contera P
Psomagen, a U.S. subsidiary of Macrogen, said it would use Korea’s “technology exception policy” to go public on the secondary KOSDAQ market.The U.S. bioscience research firm selected Shinhan Investment Corp. as the lead manager for its initial public offering on KOSDAQ.Psomagen received “A” rating in technology assessment from Korea Technology Finance Corp. and Korea Enterprise Data in Ju
The Seoul Central District Court has begun to test whether Nabota, botulinum toxin (BTX) of Daewoong Pharmaceutical, forms spores in the natural environment to end the dispute between Daewoong and Medytox over the origin of the BTX strain.The court on Thursday started the appraisal, which is expected to take about 10 days. The court is likely to have the results as early as within this month.
Kolon Life Science said it has filed an administrative lawsuit against the Ministry of Food and Drug Safety’s nullification of the license of Invossa-K with Seoul Administrative Court and Daejeong District Court on Monday.Kolon said in a public filing that the suit sought to invalidate the ministry’s decision on Wednesday to revoke the permit of Invossa, the gene therapy for osteoarthritis, an
An executive at SillaJen suddenly sold 160,000 shares for “personal reasons,” but other shareholders of the biotech firm worried the selling might signal something negative about the company’s anticancer pipeline Pexa-Vec.SillaJen said in a public filing on Monday that Shin Hyun-pil, chief science officer of SillaJen, sold all of his 167,777 common stocks on four trading acts between Monday an
The stock market operator said it would review whether to keep Kolon TissueGene on the KOSDAQ market, as the government revoked the license of its gene therapy Invossa-K.The Korea Exchange (KRX) said it would make the ruling by July 26. If the regulator delists Kolon TissueGene, its 489.6 billion won ($416.3 million) worth shares could turn valueless.The KRX said the company might have sub
Dong-A ST and Dongwha Pharm failed to renew the state-designated certification of the innovative pharmaceutical firm in the government’s review of seven drugmakers.The Ministry of Health and Welfare published the latest list of innovative pharmaceutical companies on Thursday. Earlier, seven pharmaceutical companies had their certification expired. They are Dong-A ST, Dongwha Pharm, Yungjin
Oh Kims Law & Co., leading a lawsuit against Kolon Life Science on behalf of Invossa-treated patients, said the drugmaker’s plan lacked detail and explanation to ensure the safety of the patients.“We question how the company will spend 80 billion won ($68.3 million) for 15-year follow-up tests for patients,” Eom Tae-seob, a lawyer at Oh Kim, said in a statement, responding to Kolon’s press con
Janssen, a subsidiary of Johnson & Johnson, has decided to return the development rights of antidiabetic obesity treatment (HM12525A) that the Belgium-based drugmaker in-licensed from Hanmi Pharmaceutical in 2015. “In two phase-2 trials that Janssen conducted, the drug achieved the primary endpoint of weight reduction, but its blood glucose control in obese patients accompanying diabetes fell
Yuhan Corp. recently made headlines by signing an $870 million licensing deal with Boehringer Ingelheim.Industry watchers attribute the drugmaker’s success in clinching four out-licensing agreements in one year to a steady expansion of R&D and active engagement in open innovation.Yuhan announced Monday that it agreed with Boehringer Ingelheim to develop YH25724, a candidate drug for nonalc
“The pharmaceutical and biotech industry will lead our economy soon. Even now, Korean companies are conducting several clinical trials around the world. In the near future, we might have a new blockbuster drug.”President Moon Jae-in made the remark when he announced the government’s five-year plan to support 4 trillion won ($3.46 billion) for the pharmaceutical and biotech sector, on June 22.
BNO BIO, a joint venture between Bukwang Pharm and chemical and energy company OCI, said it has decided to invest in a foreign biotech venture that owns a technology for the early detection of cancer.BNO BIO will invest $1 million in Nucleix, and the investment is the first since the company’s foundation in July last year.Established in 2008, the Israeli biotech venture has a technology th
Investors in HLB have expressed shock after the KOSDAQ-listed firm announced that its new drug candidate rivoceranib for gastric cancer failed to improve overall survival in a phase-3 global trial.HLB Chairman Jin Yang-gon held an urgent briefing in Yeouido, Seoul, on Thursday to explain about topline results of the trial disclosed a day earlier. On Wednesday, the company announ
“The National Medical Center (NMC), the Korea Centers for Disease Control and Prevention (KCDC), and the National Evidence-based Healthcare Collaborating Agency (NECA) unofficially said to the government that they could take care of Invossa-treated patients. However, the government was silent about it, and the Invossa problem remains unsolved under the management of the Ministry of Food and Drug S