“I received Invossa injection in January, but the pain got worse. I’m getting a stronger painkiller now. It hurt too much, so I checked the ultrasound and found some lumps in my knee. No one gives me a clear answer to what they are and what to do about them.”“I got Invossa treatment on March 22, and the drug was suspended in just a week. You can imagine how terrible I must have felt. My doctor
The stock market regulator granted Oscotech to become the third KOSDAQ-listed biotech company to benefit from an exception policy that supports continued research and development for new drugs.The system clears of uncertainties over the company’s risk being designated as issues for administration, but biotech industry officials said they were still unhappy about the local authorities’ regulati
Foreign drugmakers need to make the most of China’s revised drug regulations to tap the Chinese pharmaceutical market, experts said at a recent forum in Seoul. China is going through sea changes in regulations on clinical trials and drug approval.Korea National Enterprise for Clinical Trials (KoNECT) and the Korea Drug Development Fund (KDDF) held a forum on global clinical development to disc
The stock market regulator said it has pushed back the deadline to decide whether to evaluate Kolon TissueGene for a possible delisting until July 10.The delay reflects the Korea Exchange (KRX)’s cautious approach on the matter, but the biotech firm was likely to be subject to delisting review, sources said.Earlier, KRX suspended the trading of Kolon TissueGene shares to protect investors,
Expectations are rising for Lazertinib, an investigational drug that Yuhan Corp. licensed out to Janssen for the treatment of non-small cell lung cancer (NSCLC), an analyst said.Meritz Securities said in a report on Monday that the market prospect for Lazertinib continued to rise even after the meeting of the American Society of Clinical Oncology (ASCO). The brokerage advised investors to “buy
Anticipation for the Korean biohealth industry is growing amid multinational drugmaker AstraZeneca’s promise to invest $630 million in the nation’s biotech and healthcare sector over the next five years. Earlier, the government vowed to nurture the sector as one of the three core industries for national growth.To yield fruitful results with limited resources in the biotech industry, however, t
Korean biosimilars are threatening original drugs with improved competitiveness in Europe, industry officials said.Samsung Bioepis and Celltrion have demonstrated enhanced real-world data for their biosimilar products and promoted biosimilars with better patient convenience at the 2019 European League against Rheumatism (EULAR), held in Madrid, Spain, from Wednesday to Saturday.At the even
Kolon TissueGene said in a public filing on Thursday that its 294 minority shareholders were pursuing 9.28 billion won ($7.83 million) compensation for their investment losses through a lawsuit at the Seoul Central District Court.The defendants include the company, CEO Noh Moon-jong, two former CEOs Lee Woo-sok and Lee Bum-sup, former Kolon Group Chairman Lee Woong-yeol, Kolon TissueGene CFO K
Korean botulinum toxin maker Medytox is likely to face a delay in winning Chinese license for Meditoxin (export name: Neuronox), industry watchers said. Medytox recently clarified that the Chinese regulator’s suspension of review for Meditoxin was a “normal procedure for the next step.” However, industry officials noted that many other foreign pharmaceutical firms obtained the nod in China wit
Daewoong Pharmaceutical is expected to face a delay in obtaining European approval for botulinum toxin Nabota (European product name: Nuceiva), beyond the planned schedule of late July. Evolus, Daewoong’s partner firm proceeding with Nuceiva license in Europe, received a request from the European Commission (EC) to submit additional data regarding marketing authorization applications (MAA) for
Korean botulinum toxin maker Medytox said the Chinese regulator ordered the review suspension on its product Meditoxin only once, not multiple times. The clarification came after Korea Biomedical Review reported on Monday that the Chinese drug authorities were reviewing additional data and that the regulator slapped multiple review suspensions on Meditoxin. (Related news: Medytox’ botulinum to
CJ HealthCare, a subsidiary of Kolmar Korea, said Monday it would invest 100 billion won ($84.3 million) into building a new factory to produce IV (intravenous therapy) fluids.The construction of the new plant will be CJ HealthCare’s first massive investment after being acquired by Kolmar Korea in April last year. The 32,893-square meter factory will be located in the company’s factory site wi
Korean botulinum toxin maker Medytox may likely suffer a delay in Chinese regulatory approval for Meditoxin (export name: Neuronox), industry sources said.The Chinese regulatory agency suspended the approval review for the Korean product on May 24 and June 3, in addition to the similar move taken on March 13. Several suspension orders were unusual, and the Chinese agency seemingly aimed to dem
Kolon TissueGene, a subsidiary of Kolon Life Science, said Co-CEO Lee Woo-sok resigned as of Wednesday.Lee’s departure leaves Noh Moon-jong as the sole CEO of Kolon TissueGene. Lee stepped down as a director of the board at Kolon TissueGene as well.“Lee Woo-sok decided to focus on Invossa issues as CEO of Kolon Life Science, and let Kolon TissueGene CEO Noh Moon-jong concentrate on res
The Korean pharmaceutical industry called for the government to ease regulations to spur investment in artificial intelligence-based new drug development and lead the 300 billion won ($254.4 million) global market.Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) held a debate on “The Fourth Industrial Revolution and the Pharmaceutical Industry’s Future” at the National Ass
Yuhan Corp. is gearing up to develop a new lung cancer drug Lazertinib (YH25448) in the global market. In an earlier local phase-1/2 study, the agent proved efficacy and safety to extend the progression-free survival (PFS) of lung cancer patients. The company said Tuesday the U.S. Food and Drug Administration approved to go ahead with a phase-1 trial on the investigational drug on May
Minority shareholders of Kolon Life Science and its subsidiary Kolon TissueGene are pursuing more than 25 billion won ($211.5 million) compensation for their investment losses. They argue the damage was incurred by the suspension of osteoarthritis gene therapy Invossa-K following the mislabeling of the drug’s ingredient.On May 27, Jeil, a law firm, moved first to file a claim of compensation f
Former Kolon TissueGene CEO Lee Kwan-hee, the inventor of now-suspended gene therapy Invossa-K, had reportedly sold off his all stakes of Kolon Life Science just before Kolon won Invossa license in 2017.At that time, stock prices of Kolon Life Science hovered at around 120,000 won ($101.5) per share, which was nearly at the record high level.When Lee Kwan-hee was a professor at Inha Univer
Hanmi Pharmaceutical’s new combination drug Amosartan (losartan/amlodipine) to treat hypertension was effective in controlling central blood pressure, compared to a combo of losartan and hydrochlorothiazide (HCTZ), the company said. The American Journal of Hypertension published the study results recently. The study was part of “The K-Central Study,” led by Kyung Hee University Medical Center’
Samsung BioLogics said it has signed a deal with U.S. biotech firm CytoDyn to manufacture investigational HIV treatment leronlimab at its headquarters in Songdo, Incheon, on Thursday.The deal, publicly disclosed in early April, is worth at least $31 million. The amount may increase up to $246 million by 2027 if CytoDyn successfully develops the drug into a product and starts commercializat