Handok Pharmaceuticals has decided to conduct a clinical trial of ABL001, or CTX-009, a bispecific antibody targeting cancer cells, in the U.S. with its local partner, Compass Therapeutics.The two companies plan to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Admini
GC said Tuesday that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to Hunterase ICV (intracerebroventricular), its treatment of severe hunter syndrome using a ventricular injection.The EMA based its decision on the clinical data of Hunterase ICV, which showed that it
JW Pharmaceutical said Tuesday that its dyslipidemia drug Rivaro (ingredient: pitavastatin) induced fewer side effects, such as diabetes, than other statin drugs through a study conducted in Taiwan.Researchers compared the cumulative risk of developing diabetes, hepatitis, and myopathy among partici
While Korean pharmaceutical and biotech companies have been slow to develop Covid-19 treatments, some continue developing Covid-19 drugs using natural ingredients.Industry watchers pay attention to whether they can complete drug development because it is not easy to recruit trial participants amid a
CubeBio, a company specializing in vitro diagnostics for early cancer detection, has advanced to the Russian market by signing an export contract.On Monday, the company said it signed an export contract with Russia’s Standart-Biotest and an investment agreement with the European Union at the Federat
EuBiologics said it has completed phase 3 clinical trials of its originally developed vaccine, EuTCV, against typhoid fever conducted in the Philippines.The company has been conducting studies to verify the efficacy of the typhoid vaccine in 444 healthy people aged six months to 45 years with De La
The government has begun to discuss granting health insurance benefits for an antidiabetic combination therapy combining dipeptidyl-peptidase 4 (DPP4) and sodium-glucose cotransporter-2 (SGLT2) inhibitors, touching off a competition among local drugmakers to join the market.Ildong Pharmaceutical rol
Korean pharmaceutical companies received lower ratings than non-pharma businesses in the environment section in their environmental, social, and governance (ESG) performance, according to the Korea Corporate Governance Service (KCGS).To address this problem, they should check ESG issues regularly an
Hanmi Pharmaceutical has commercialized its first new biomedicine, Rolontis (ingredient: eflapegrastim), a long-acting neutropenia treatment and Korea's 33rd novel drug.Hanmi said on Monday that it expects Rolontis to provide new options for a prophylactic prescription that can restore abnormally de
Researchers have expressed different opinions on why the U.S. FDA requested Amgen conduct a low-dose trial of Lumakras (sotorasib), the first Kras G12C inhibitor to treat cancer.The latest issue of the Journal of Clinical Oncology (KCO), a journal by the American Society of Clinical Oncology (ASCO),
Companies that falsely report the source of the botulinum toxin (BTX) strain will likely have to shut down their business, as the government amended the Infectious Disease Prevention Act on managing high-risk pathogens.According to the industry sources on Friday, the amendment allows authorities to
MSD said Friday that the company plans to supply molnupiravir, its oral Covid-19 therapy under development, to Korea by receiving emergency use authorization (EUA) from the local regulatory agency.MSD’s move comes as the Korean government negotiates with global pharmaceutical companies to import ora
Curacle said Friday that it has signed a 2.3 trillion won ($1.97 billion) licensing and collaboration agreement with Thea Open Innovation to develop oral therapy CUE06-RE for diabetic macular edema and wet age-related macular degeneration.Under the accord, Thea Open Innovation, a sister company of T
Daewoong Pharmaceutical and Medytox have been continuing their domestic legal battles over the source of the botulinum toxin (BTX) strain for years.Industry officials are now paying attention to how the U.S. International Trade Commission (ITC)’s recent annulling of its final determination on the im
GC Pharma has again delayed confirming whether or not rumors about its manufacturing of Janssen’s Covid-19 vaccine were true.In a public filing on Thursday, GC Pharma said it made no specific decision regarding news reports on Aug. 28 about the possibility of producing Janssen’s vaccine.The latest a
The Supreme Court, on Thursday, dismissed the appeal filed by Novartis against Hanmi Pharmaceutical and Ahngook Pharmaceutical over the patent extension term of Galvus (ingredient: vildagliptin), closing the four-year-long patent dispute.The recent ruling marks the first case of domestic pharmaceuti
Hanmi Science said that it has entered a pandemic science alliance with the University of Oxford to conduct research to prevent new and mutated infectious diseases.“The pandemic, along with the basic vaccine supply problems in many countries, has brought us together,” Hanmi Science CEO Lim Jong-yoon
Dong-A ST received regulatory approval to conduct its third phase 1 clinical trial of donepezil transdermal patch for treating Alzheimer’s disease to check for optimum dose in long-term attachment.The phase 1b clinical trial of DA-5207, the company’s donepezil patch, is an additional study requested
Local pharmaceutical companies are obtaining the marketing approval for generic copies of Jardiance, an antidiabetic SGLT-2 inhibitor, one after another. The move is regarded as an early preparation to secure the Jardiance generic market when the patent of Jardiance expires in 2025.On Wednesday, the
Genencell said that the Ministry of Food and Drug Safety has approved the company’s investigational new drug (IND) application to conduct phase 2 and 3 clinical trials for ES16001, an oral Covid-19 treatment.Genencell explained that the ministry’s approval signals the official start of global clinic