Vivozon Healthcare obtained the Ministry of Food and Drug Safety (MFDS) approval for a phase 2 trial of Opiranserin (VVZ-149), a non-narcotic analgesic.The MFDS authorized the local phase 2 study of Opiranserin creme on Monday, two months after receiving Vivozon Healthcare’s application. The study w
Bayer’s endometriosis treatment Visanne (ingredient: dienogest) demonstrated long-term pain reduction and improvement in quality of life in real-world settings in six Asian countries, the company said.Bayer published the final results of the real-world ENVISIOeN trial of Visanne in Reproductive Scie
Organon Korea said Wednesday that the company would do its best to address unmet needs for women's health during their entire lifespans, such as contraception, infertility, pregnancy and childbirth, and menopause."There is a relatively high unmet need in diseases related to women's entire life cycle
Celltrion Pharm said Wednesday it would begin the sales of Yuflyma, a new biosimilar of AbbVie's blockbuster drug Humira (Ingredient: Adalimumab), in Korea.Yuflyma obtained product approval from the European Medicines Agency (EMA) in February last year and started sales in Europe.In Korea, the compa
Eutilex said it has entered into a partnership with OBio Technology, a Chinese-based pharmaceutical company, to collaborate in clinical trials and commercialization of cell therapy pipelines in China.Under the accord, Eutilex will start clinical trials and commercialize EBViNT, its killer T-cell the
SK Bioscience said it published the results of the phase 2 trial of the second dose of investigational typhoid conjugate vaccine NBP618, being jointly developed by the International Vaccine Institute (IVI), in the online version of the January issue of Nature's partner journal, Vaccines. SK Bioscien
The government said it included Kolon Pharma’s psoriasis oral treatment Skilarence (ingredient: dimethyl fumarate) in the list of patented drugs. Industry officials are paying attention to Skilarence’s prescription sales, as the drug won health insurance benefits early this year. The Ministry of Foo
Bayer said its second-generation androgen receptor-targeted agent (ARTA), Nubeqa (ingredient: darolutamide), has proven its efficacy in treating metastatic hormone-sensitive prostate cancer (mHSPC).The company’s announcement follows the results of the ARASENS study, a phase 3 clinical trial of Nubeq
Short sellers are targeting biopharmaceutical stocks after the authorities allowed the partial resumption of short-selling last year.The government permitted the resumption of short-selling Kospi 200 and Kosdaq 150 stocks last May after banning it for one year and two months to prevent a market cras
The financial regulator recently lifted the designation of the administrative issue for JW Life Science, almost one year after imposing it. The administrative issue has been a negative factor for the company’s stock price, and whether the lifting of the designation will recover the stock price is dr
The Korean botulinum toxin (BTX) market enters the fiercer competition as three more botulinum toxin (BTX) preparations aim to release their product this year.According to industry officials, Inibio, Eubiologics, and Pharma Research Bio have completed their BTX phase 3 clinical trials and expect to
GC said that it faces additional delays in entering the U.S. market with GC5107, its flagship blood derivative product, due to its failure to provide an on-site inspection to the U.S. Food and Drug Administration (FDA).GC reported that it had received a notice of delay in product approval through GC
Daewoong Pharmaceutical applied for a trademark, Acelcox (ingredient: polmacoxib), presumed to be a generic drug of Acelex, an osteoarthritis pain reliever.Acelex is the nation’s 22nd novel drug developed by Crystal Genomics. The treatment is a selective cyclooxygenase-2 (COX-2) inhibitor designed t
SK Biopharm finished recruiting patients for a phase 3 trial of epilepsy drug cenobamate in Korea, China, and Japan, stepping closer to the Asian epilepsy treatment market entry, industry sources said.On Thursday, the sources said SK Biopharm completed patient enrollment for the phase 3 trial of cen
Biohaven Pharmaceutical said rimegepant (brand name: Nurtec), an oral migraine drug-seeking marketing approval in Korea, will test its potential to treat chronic rhinosinusitis (CRS).The neurological disease specializing company said it recently started enrolling patients with CRS in the phase 2/3 t
“By collaborating with Atara Biotherapeutics, we will develop the next-generation CAR-T cell therapy for mesothelin-expressing solid cancers such as malignant pleural mesothelioma (MPM) and lung cancer that have high unmet medical needs. Ultimately, we aim to introduce an allogeneic CAR-T cell thera
Energy and chemicals company OCI will become the largest shareholder of Bukwang Pharm, the drugmaker said.The decision to sell Bukwang’s stock to OCI came even though the previous largest stakeholder, Chairman Kim Dong-yeon, and his eldest son and president, Kim Sang-hoon, had tight control over the
“Type-2 diabetes treatment Trajenta (ingredient: linagliptin), an oral once-daily medication without the need for a dose control, ranked first in market share among single agents excluding insulin.”On Tuesday, Boehringer Ingelheim Korea held a news conference celebrating the 10th anniversary of the
Daewoong Pharmaceutical and Chong Kun Dang received the regulatory nod, respectively, to conduct phase 1 studies of a four-drug combination treatment for hypertension/hyperlipidemia.On Monday, the Ministry of Food and Drug Safety authorized two phase 1 trials of DWJ1451, and the trials will take pla
Eyegene said on Monday that it received the Australian regulator’s authorization to conduct a phase 1/2a trial of EG-COVID, an mRNA Covid-19 vaccine candidate.The company plans to evaluate the safety and immunogenicity of EG-COVID’s booster dose in the phase 1/2a study, it said.In the phase 1 study,