Novartis Korea said Tuesday that it obtained permission from the Ministry of Food and Drug Safety on June 9, to market Scemblix to treat adults with chronic myeloid leukemia who had received two or more tyrosine kinase inhibitors (TKI).Chronic myeloid leukemia is a malignant blood disease caused by
Helixmith has decided to postpone announcing the interim results of the U.S. phase 3 clinical trial for diabetic peripheral neuropathy (DPN) using its new gene therapy, Engensis (VM202), until next month, its top manager said.The company had planned to share the results of the Independent Data Monit
Celltrion said it would change its strategy for developing a Covid-19 treatment to respond to the rapidly changing pandemic situations after the emergence of the Omicron variant.For instance, the company will scrap its plan to develop an inhaled cocktail antibody treatment that adds CT-P63, a candid
Dae Hwa Pharm said it applied to the drug regulator for a change in the post-marketing surveillance (PMS) plan for Liporaxel (ingredient: paclitaxel), chemotherapy to extend the September deadline of the drug re-evaluation.The Ministry of Food and Drug Safety’s central pharmaceutical review committe
BL, a new drug developer, said Monday that it has obtained approval for administering patients with BLS-H01, a drug aimed at treating all Covid-19 variants.The Institutional Review Board (IRB) of Gachon University Gil Medical Center approved the phase 2 clinical trial of BLS-H01, a medication for Co
“In conducting this study, I met many insiders of the active pharmaceutical ingredient (API) industry, and most of them said, ‘We are like abandoned children,’ or ‘Everyone knows that the pharmaceutical industry can hardly move forward without a competitive API sector. Unfortunately, however, the go
The government has included vaccines and other biopharmaceutical technologies into its list of core strategy technology to produce raw materials, parts, and equipment, drawing keen attention from related industries.Last Thursday, the Ministry of Trade, Industry and Energy said it would add four biop
Chinese pharmaceutical companies, including Antengene, Everest Medicines, and BeiGene, established Korean offshoots recently. Unlike other Chinese companies that used to export drug ingredients to Korea, these companies aim to target the Korean market with innovative drugs for serious diseases like
VT BIO said the company received approval to conduct clinical trials of its VT301 drug to treat Alzheimer's disease of antigen-specific self-regulated T cells by the U.S. Food and Drug Administration on Thursday.This U.S. clinical trial is the second one to treat Alzheimer's disease using regulated
Roche Diagnostics Korea said on Friday that their cobas EBV and cobas BKV tests for monitoring viruses and infections of organ transplant patients have received approval from the Ministry of Food and Drug Safety.The cobas EBV test indicates the need for potential treatment changes in patients under
Canaria Bio said that it has agreed to start a joint clinical trial with GSK in patients with platinum-sensitive recurrent ovarian cancer. The two companies aim to confirm the safety and efficacy of combination therapy using Canaria Bio's Oregovomab and GSK's Zejula (ingredient: niraparib).Canaria B
HLB Therapeutics will invest $30 million in Immunomic Therapeutics, HLB's U.S. affiliate developing the next-generation cell therapy anticancer vaccine.HLB Therapeutics said it signed a binding term sheet with Immunomic on Tuesday. Some outside investors also invested, acquiring bonds with warrants
Domestic medical distributors have repeated their demand on multinational pharmaceutical companies to cooperate with improving the distribution margin for insulin preparations, threatening to take “drastic steps” if the companies continue to ignore their demand.According to industry insiders, the Ko
Kolon Pharmaceutical has voluntarily canceled the approval for Comiflu, a prescription flu medicine, after causing a controversy about whether its drug distribution to a daycare via a donation group without a doctor’s prescription was illegal.The Ministry of Food and Drug Safety said the permit for
Onconic Therapeutics said its double-inhibition targeted anticancer drug, OCN-201, has won the Ministry of Food and Drug Safety’s approval for a domestic phase 2 clinical trial as an investigational new drug (IND) to treat ovarian cancer.OCN-201 is a double-inhibiting targeted anti-cancer drug (Poly
Korean health authorities have set about to take safety steps in response to foreign information that a new nitrosamine impurity has been detected in aciclovir medicines. Aciclovir is an antiviral medicine that treats infections caused by the herpes virus -- cold sores and genital herpes --, chicken
Doctors operating obstetrician and gynecologist (OB/GYN) clinics expressed outrage Monday toward MSD Korea's decision to raise the price of Gardasil 9, a vaccine to prevent cervical cancer, in the second half, following a similar price hike last year.On May 9, MSD Korea decided to increase the suppl
Zuellig Pharma Solutions Services Korea (SSK), an affiliated company with Zuellig Pharma Korea, has been embroiled in civil and criminal lawsuits over allegations of unfair labor practices and layoffs for over a year.While the Korean judiciary system has yet to decide on the matter, SSK CEO Erwan Vi
Kangstem Biotech said Monday that it has voluntarily withdrawn a phase 1 and 2a clinical trial investigational new drug (IND) approval for "FURESTEM-OA Kit Inj.," a candidate material for stem cell-based osteoarthritis (OA) treatment.The company decided to withdraw its plans after determining that i
Roche has been pursuing “agile transformation” to make the organization and business operation speedy and flexible.Roche Korea, the Korean offshoot of the Swiss multinational healthcare company, followed suit and introduced a new business model last year to help provide patient/client-centered care.