Domestic pharmaceutical companies are actively developing combination drugs, government data showed.The Ministry of Food and Drug Safety said on Friday it authorized 2,482 medicines last year, with an increased proportion of combo drugs compared to a year earlier.The 2,046 finished drugs were 1,886 chemical drugs, 28 biopharmaceutical drugs, and 132 herbal medicinal products. They included
The health authorities said here they have received the first report of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a local patient who had Allergan’s specific type of textured implant.The Ministry of Food and Drug Safety and Korean Society of Plastic and Reconstructive Surgeons (KSPRS) said Friday they had the first report of BIA-ALCL.The patient was a female in
Domestic pharmaceutical companies are rushing to develop a treatment for non-alcoholic steatohepatitis (NASH).NASH is an inflammation of the liver caused by a buildup of triglycerides in the liver, even when the person rarely drinks alcohol. If it gets worse, it may cause severe fibrosis or cirrhosis. Obese and diabetic patients are highly likely to develop NASH, but there is no treatment.
The Korean drug regulator has approved a phase-3 clinical trial on Eylea (ingredient: aflibercept), an anti-vascular endothelial growth factor (anti-VEGF) injection, for the treatment of retinopathy of prematurity (ROP) in premature babies.The Ministry of Food and Drug Safety on Monday granted Bayer Korea to go ahead with the phase-3 study on Eylea.The study will evaluate the long-time
Four deaths occurred during Yuhan Corp.’s clinical trial on new lung cancer treatment Lazertinib, but three did not have to do with the investigational drug, the regulator ruled. The ruling allows Yuhan to continue the Lazertinib trial.The minutes of the Ministry of Food and Drug Safety (MFDS)’s central pharmaceutical affairs advisory committee on Friday showed that four patients died during t
The Ministry of Food and Drug Safety on Thursday announced a “Comprehensive Five-year Plan for the Advancement of Clinical Trials,” aimed at upgrading local clinical trials by 2023.The comprehensive plan, composed of three key strategies and 21 detailed tasks, is to broaden treatment opportunities for rare and intractable diseases, protect the rights of clinical trial participants, and improve
The local drug regulator has approved a new obesity treatment, Qsymia Cap. (ingredient: phentermine/topiramate), giving more options to obese people.However, the use of Qsymia is likely to be limited because regulators categorize it as a psychotropic drug. Physicians must report the prescription of Qsymia to the government’s narcotics information management system.The Ministry of Food and
One in 45 Koreans was prescribed with an appetite suppressant for obesity treatment, and most of them were women, government data showed. By age group, those in their 30s used the drug the most.A patient should not take an appetite curbing agent together with another, and the administration period is usually confined to four weeks, with three months at maximum. However, 10 percent of the patie
Recent SBS drama “Doctor John” and MBC’s “Partners for Justice Season 2” used Fabry disease as the key material for stories, drawing viewers’ attention to the rare disease.In “Doctor John,” protagonist Cha Yo-han (played by Ji Sung) diagnoses a convict’s symptoms as Fabry disease, treats him, and saves his life. In “Partners for Justice Season 2” which ended on Monday, lead character Baek Beom
Drug output by 30 largest pharmaceutical companies accounted for 54 percent of the total production in the past three years, government data showed.According to the Ministry of Food and Drug Safety, the nation produced 21.1 trillion won ($17.82 billion) worth drugs in 2018, up 3.7 percent from 20.35 trillion won in 2017. The drug output took up 1.18 percent of the gross domestic product in 201
Kang Yoon-hee has been working as a committee member of the Clinical Trial Task Force at the National Institute of Food and Drug Safety Evaluation under the Ministry of Food and Drug Safety, over the past two years. She is a specialist in laboratory medicine and belongs to the clinical examination task force composed of doctors. Kang held a one-person protest in front of the Nation
The drug regulator said it has granted S.Biomedics to extend the submission of phase-3 clinical data for CureSkin Inj., autologous cell therapy for acne scars that had won conditional approval.According to the minutes released by the Ministry of Food and Drug Safety’s central pharmaceutical affairs advisory committee on Friday, the government allowed the extension of data submission.The co
The Ministry of Food and Drug Safety denied a suspicion that the ministry poorly monitored the quality control of Meditoxin, a botulinum toxin product by Medytox.The ministry will ask an investigation agency to probe the case to resolve the suspicion that the key decision-maker in the Meditoxin approval process was either a shareholder of Medytox or a person associated with the shareholder
The government warned that ibandronate injections for the treatment of osteoporosis could cause acute renal failure, a serious adverse reaction.The Ministry of Food and Drug Safety issued the warning on Tuesday and said it would order pharmaceutical firms to add acute renal failure in precaution labels of ibandronate injections.Local post-Marketing surveillance on ibandronate reported acut
Pfizer Korea has failed to reduce the number of target participants in post-marketing surveillance (PMS) of Xeljanz (tofacitinib), an oral drug for rheumatoid arthritis.Earlier, the company requested the Ministry of Food and Drug Safety to adjust the number of enrollment for Xeljanz PMS from 3,000 to 700, citing difficulty in recruiting patients.However, the ministry’s Central Pharmaceutic
The government has decided to nullify Invossa-K’s license effective next Tuesday, but the company expects the U.S. Food and Drug Administration to allow it to resume phase-3 trial on the gene therapy for knee osteoarthritis.Kolon Life Science said Wednesday it planned to correct the labeling of the cell ingredient of Invossa’s second fluid as kidney-derived cells (GP2-293 cells), instead o
Kolon Life Science CEO said he would seek an administrative suit against the drug regulator’s decision to nullify the license of Invossa-K, gene therapy for knee osteoarthritis, and dispute the regulator’s allegations against the drugmaker in court.CEO Lee Woo-sok told reporters on Tuesday that he did not think that the mislabeled 293 cells in Invossa can be a valid reason to cancel the drug l
Twenty-six new pharmaceutical products received approval in Korea in the first half year. All of the drugs can be directly administered to patients, except for Tristel Spori Wipes & Form, a prescription drug for endoscopy disinfection.According to the Ministry of Food and Drug Safety, the 26 new drugs were mostly treatments for rare disease or cancer, rather than those for chronic diseases suc
The regulator ordered multinational pharmaceutical firms, including MSD Korea, to suspend drug imports after the companies failed to comply with the local safety regulations.The Ministry of Food and Drug Safety ruled that Ferring Pharmaceuticals Korea, MSD Korea, and Merz Korea would be banned from importing some of their drugs for two weeks, a week, and a month, respectively. Ferring Kore
The government said it would help patients get compensation for diseases caused by drugs’ side effects.The Ministry of Food and Drug Safety said the scope of the “Pharmaceutical Product Drug Side Effect Damage Compensation Program” will be expanded from reimbursable drugs to non-reimbursable ones. The program provides financial compensation for a patient or family when the person affected