Spectrum Pharmaceuticals, a U.S. partner company of Hanmi Pharmaceutical, will hold a Type-A meeting with the FDA to win approval for Rolontis (eflapegrastim), a treatment for neutropenia.Through a Type-A meeting, a company can take the feedback from the FDA and address issues impeding drug approval
The domestic botulinum toxin (BTX) drug market is going through significant changes in terms of production and import, government and business officials said.According to the Ministry of Food and Drug Safety Friday, the production and import of 17 BTX drugs, including Botox, Botulax, Medytoxin, and
Global pharmaceutical companies’ investment in R&D in Korea has continued to rise for the fifth consecutive year in 2020, an industry group report showed.The number of early clinical trials and studies of cancer and rare diseases increased significantly, and employment for R&D also expanded steadily
Merck’s oral antiviral treatment for Covid-19, molnupiravir, has reportedly shown potential efficacy on the variants of the Covid-19 virus, causing Korean companies to speed up efforts to develop similar oral medicines.Merck, or MSD in the U.S. and Canada, said Wednesday its experimental Covid-19 th
Takeda Korea said its ovarian cancer treatment Zejula would receive expanded health insurance coverage as maintenance therapy for breast cancer (BRCA) susceptibility gene-mutated ovarian cancer patients who responded to first-line platinum-based therapy from Friday.Under the latest revision, the gov
Korea Research Institute of Chemical Technology (KRICT) said Thursday that an HIV treatment candidate developed by its team has been transferred to a domestic company and began sales in China as a new drug.The institute said that the drug candidate, once could have been thrown away, was transferred
Bukwang Pharmaceutical said it would withdraw its plan to develop its antiviral drug Levovir (clevudine) as a Covid-19 treatment.The company said it had no intention to work on the drug again.Industry watchers said Bukwang’s failure to achieve the primary endpoint in a recent trial made it almost im
The government said Thursday that it would provide various support for companies to develop at least one homegrown mRNA Covid-19 vaccine by 2023.Next year, it will spend 526.5 billion won ($444 million) to help drugmakers conduct clinical and non-clinical studies while pre-purchasing homegrown Covid
JW Pharmaceutical has begun marketing Livalozet, the first domestic combination drug of pitavastatin and ezetimibe, for treating dyslipidemia.The company said its dyslipidemia therapy doses are available in 2 or 4 milligrams of pitavastatin with 10 mg of ezetimibe. Medical professionals and patients
Korean pharmaceutical companies are increasingly jumping into the Avastin (bevacizumab) biosimilar market.Samsung Bioepis won local approval for its Avastin biosimilar in March, and Pfizer Korea, in May. Celltrion is the latest player to enter the Avastin biosimilar market.In a regulatory filing on
Chong Kun Dang said that the Ministry of Health of Ukraine has approved the company to conduct a phase 3 clinical trial of Covid-19 drug candidate, Nafabeltan (ingredient: nafamostat).Ukraine is the first foreign country to authorize Chong Kun Dang’s phase 3 study following the approval granted by t
Recent media reports about GC Pharma in talks with Janssen for a consigned agreement manufacturing Covid-19 vaccines have been revealed as rumors -- at least so far -- industry sources said Wednesday.The two companies acknowledged they had met but stopped short of providing detailed information over
Korea United Pharm took legal action to protect its patent of antitussive drug Levotics CR Tab. (levodropropizine) against generic copies.The company said on Tuesday that it filed a lawsuit against 15 generic drugmakers that allegedly infringed upon the patent of Levotics CR Tab.Korea United Pharm d
GC Labcell said that it has published a paper related to genetically engineered support cells, one of its culture platform technologies, in the latest issue of Cellular & Molecular Immunology.“This paper is about a unique technology for support cells that induce proliferation and activity of natural
Daewoong Pharmaceutical and Daiichi Sankyo Korea said they have found no azido methyl biphenyl tetrazole (AZBT) in 21 olmesartan drugs for high blood pressure during the recent inspection.The two companies performed the inspection following Health Canada's measure to recall treatments after detectin
AstraZeneca’s Lynparza tablet (ingredient: olaparib), a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, has become reimbursable for the first- and second-line maintenance therapy in ovarian cancer patients.The anticancer drug shifted its form from capsule to tablet and obtained health
Hanall Biopharma has begun administrating HL161 (ingredient: batoclimab) in phase 3 clinical trials conducted in China for treating myasthenia gravis. Harbour Biomed, Hanall Biopharm’s Chinese partner, is conducting clinical trials in patients with a rare long-term condition that causes muscle weakn
Local developers of Covid-19 vaccines have announced plans to conduct large-scale, late-stage global trials, raising expectations for homegrown Covid-19 vaccines.However, some companies have to overcome several challenges, and it will take some time to commercialize a local Covid-19 vaccine, observe
Daewon Pharmaceutical said that it found TG Fenon (Ingredient: fenofibrate choline) significantly reduces triglyceride levels, reaffirming its safety in phase 4 clinical trial of treating patients with hypertriglyceridemia.The company compared triglyceride reduction between patient groups that recei
Novartis’ CDK4/6 inhibitor Kisqali (ribociclib), combined with letrozole, extended overall survival by more than one year in patients with hormone receptor-positive, human epidermal growth factor 2-negative (HR+/HER2-) advanced breast cancer.The company released the results of phase 3 MONALEESA-2 tr