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,
MSD’s anti-PD-1 immunotherapy Keytruda (pembrolizumab) obtained health insurance benefits five years after winning marketing approval to treat advanced non-small cell lung cancer (NSCLC) in Korea in March 2017.The government also established the reimbursement criteria for Xospata (gilteritinib), the
HanAll Biopharma said it scouted Almira Chabi, chief medical officer and chief development officer of HPI, to enhance the company’s R&D capabilities.Chabi has been leading the global development and licensing of new drugs. After graduating from the School of Medicine at the University of Wisconsin-M
HK inno.N’s K-Cab (tegoprazan), a treatment for gastroesophageal reflux disease (GERD), is more effective in reducing night-time gastric acid than not only an existing proton pump inhibitor (PPI) but another potassium-competitive acid blocker (P-CAB), a study said.The company plans to use the study
“As a pharmaceutical company that makes drugs directly affecting Korean people’s health, we will walk on the right path with unwavering faith.”So said Korea United Pharm CEO Kang Duk-young at a group interview with health journalists where he evaluated the company’s performance last year and shared
Amid the slump of biopharmaceutical stocks, some companies have set out to buy back their shares, which analysts regard as a move to appease shareholders by stabilizing stock prices.For instance, Celltrion Healthcare, a comprehensive healthcare company, said Friday that it had decided on a buyback p
The American Society of Clinical Oncology (ASCO) updated adjuvant therapy guidelines in early lung cancer in five years, strongly recommending AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI) Tagrisso (ingredient: osimertinib).On Tuesday, ASCO renewed the 2017 guideline on systemic adjuvant and ra
Yuhan Corp. recorded sluggish 2021 earnings, but the performance was rather a success given the base effect from licensing fee profits in 2020, analysts at investment banks said.On Wednesday, Yuhan posted a public filing as its sales and profit structures changed more than 30 percent. According to t
Opdivo (nivolumab), anti-PD-1 immunotherapy co-developed by Ono Pharmaceutical and BMS, added five indications for esophageal/gastroesophageal junction cancer, colorectal cancer, bladder cancer, renal cell cancer, and lung cancer in Korea.On Monday, the Ministry of Food and Drug Safety granted addit
Korean pharmaceutical and biotech companies are introducing a new standard for a compliance management system, ISO 37301, to enhance internal monitoring and prepare for ethical management of ESG (environmental, social, and corporate governance).Their move came mainly after the embezzlement case earl