Kolon Life Science might get its sales license of Invossa-K revoked, as the regulator found that the drug contained cell ingredients that were different from those at the time of approval in 2017.Depending on the results of the Ministry of Food and Drug Safety’s investigation, the ministry could nullify approval for the arthritis treatment as an administrative punishment.Kolon is making an
After the Ministry of Food and Drug Safety announced that it would gradually scrap the “consigned bioequivalence test system” in February, the number of approvals for generic drugs in the first quarter almost doubled compared to a year earlier.The system allows incompetent drugmakers to sell generic drugs by relying on another company to conduct bioequivalence tests.According to data from
The Ministry of Food and Drug Safety said it would investigate the safety issue of Kolon Life Science’s arthritis drug Invossa-K with all possibilities open, even though the company said the injection was safe.Depending on the timing of the cells being mislabeled and intentionality, the pharmaceutical firm will face a different level of administrative or criminal punishment, it said.Kolon
The Korean health authorities said they would update approval condition for Stivarga (regorafenib) after learning that Europe had a report of peripheral neuropathy in a patient who took the liver cancer medication.The Ministry of Food and Drug Safety said Tuesday it would review the European Commission’s safety information about regorafenib and reflect it on the local license.Periphera
The regulator has caught 12 bodybuilders and trainers who smuggled muscle-enlarging anabolic steroids and sold them with a drug wholesaler license.The Ministry of Food and Drug Safety said it booked the 12 offenders including a former bodybuilder surnamed Kim for illegally selling prescription drugs and smuggling anabolic steroids. Anabolic steroid is one of the male steroids (testosterone) ex
A bill to support advanced regenerative medicine and high-tech biopharmaceuticals is likely to pass the National Assembly’s legislation and judiciary committee on Thursday, after getting the nod from the health and welfare committee.The bill will become a law if it wins final approval at the assembly session scheduled on Friday.The government and the biotech industry is raising hope that t
The drug authorities will decide the level of a sanction against Kolon Life Science depending on the results of cell analysis of Invossa-K Inj., reportedly to be released on April 15. The company recently suspended the sale of the degenerative arthritis treatment after discovering that it has mislabeled one of the drug’s cell ingredients. In light of the Invossa mishap, the regula
The regulator has caught an Oriental medicine practitioner and a pharmacist who illegally mixed dexamethasone, a steroid, into herbal medicine “Dongpungsan” and sold to patients suffering from gout. Only Western medicine doctors are authorized to prescribe dexamethasone, which has an anti-inflammation effect. The two offenders put dexamethasone equivalent to 2.4 times the daily minimum dose in
The Korean regulator would add a precaution label to argatroban, a treatment for acute cerebral thrombosis, warning that the drug could raise hemorrhage risk in pregnant women, fetuses, and newborns.The Ministry of Food and Drug Safety said Monday that it would place the warning on five argatroban-containing medicines.Argatroban-based drugs are indicated for improvement of limb ulcer, pain
The government has granted the nod to go ahead with phase-3 trials on deutetrabenazine (brand name: Austedo in the U.S.), a new treatment for Huntington’s chorea developed by Teva, to check its efficacy for Tourette syndrome.The Ministry of Food and Drug Safety gave approval for phase-3 trials on Feb. 7 and Feb. 27, respectively, to evaluate whether the drug works on the neurodevelopmental dis
Advertisements of hydrogen water often promote that it helps remove fine dust from the human body and treat diseases. However, it does not offer any antioxidative or disease-treating effect, government and private experts said.The Ministry of Food and Drug Safety said Wednesday it examined the ads of hydrogen-containing drinks and confirmed that hydrogen water, or pure water with hydrogen gas
Hanlim Pharm said it would test HL301, a drug candidate for bronchitis, to check if it can treat radiation pneumonitis. The move is to obtain the medicine’s additional indication for radiation pneumonitis, observers said.The Ministry of Food and Drug Safety on Friday granted the nod to Hanlim Pharm to go ahead with the phase-2a trial on HL301.The study will be on 87 patients with primary l
Eubiologics said it has begun developing a botulinum toxin product.The Ministry of Food and Drug Safety on Tuesday approved the company to conduct a phase-1/2 trial on its BTX candidate “ATGC-100 Injection,” it said.Eubiologics’ study will evaluate ATGC-100’s safety and effect in adult patients with moderate or severe frown lines. In the phase-1 trial, the treatment will be tested in 10 pa
Two classes of the drug for enlarged prostate -- 5-alpha reductase inhibitors and alpha blockers -- showed no difference in depression risk, according to a study by the Korea Institute of Drug Safety and Risk Management. Alpha blockers such as alfuzosin and 5-alpha reductase inhibitors are the most popular treatments for benign prostatic hyperplasia (BPH). Finasteride, one of 5-alpha r
The Ministry of Food and Drug Safety urgently notified that OncoTICE injection (ingredient: BCG strain tice), a treatment for bladder cancer, was not in shortage after rumors circulated that the medication might have been sold out.Some news reports continued to raise concerns that MSD Korea might not be able to meet the local demand for OncoTICE until next year, even though the health authorit
Korean researchers said they have discovered a way to help diabetic patients receive dental implants more successfully.The research team, led by Lee Jae-hoon, a professor of prosthodontics at Yonsei University College of Medicine, published a paper on Molecules, an international journal of chemistry, to explain why diabetic patients often have implant failure and how to resolve the issue.
Korean children waiting for urgent heart surgeries will be able to get 20 artificial blood vessels from a U.S. manufacturer, the government said Monday.The Ministry of Food and Drug Safety and the Ministry of Health and Welfare said W.L. Gore decided on Monday to immediately supply 20 artificial blood vessels for urgent surgeries for Korean pediatric patients.Replying to the Korean governm
A professor has unveiled a new medical record that confirmed Japan’s brutal suppression of Korean resistance during the March 1 Independence Movement in 1919.Hong Chang-hee, a professor at urology department at Yonsei University College of Medicine, announced that some of the independence activists who were flogged by the Japanese military for joining the March 1 demonstrations received skin g
Korean health officials said they would soon visit the headquarters of W.L. Gore in the U.S. to help supply the company’s artificial blood vessels for Korean children with heart conditions.Gore was the sole provider of artificial blood vessels for the surgery of pediatric patients with congenital complex heart malformations, but the company withdrew from Korea in October 2017.As the decisi
Exposure to secondhand smoke can elevate the risk for chronic kidney disease, a local study found.Park Jung-tak, a professor at nephrology department of Yonsei University College of Medicine, and his research team published a paper, “Secondhand Smoke and CKD (chronic kidney disease),” on the online issue of the Clinical Journal of American Society of Nephrology on Thursday.According to the