The government has banned the off-label use of sirolimus, an immunosuppressant drug, in pediatric patients with pulmonary vein stenosis.Off-label use refers to prescribing drugs for unapproved indications for medical needs.The authorities refused to allow the off-label use of sirolimus, according to the minutes of the Ministry of Food and Drug Safety’s Central Pharmaceutical Affairs Counc
Nine government agencies have set about to crack down on the distribution of illegal drugs, amid a drug scandal at a night club in southern Seoul called Burning Sun.News reports said club staffs have allegedly drugged women with gamma-hydroxybutyrate (GHB), known as a date rape drug, before matching them with VIP guests.The nine agencies are Office for Government Policy Coordination, the M
Lilly Korea is to conduct a clinical trial on rheumatoid arthritis drug Olumiant (ingredient: baricitinib) to check whether it will work for alopecia areata, also known as spot baldness.The Ministry of Food and Drug Safety on Monday approved the drugmaker to go ahead with a phase-2/3 study on barcitinib (LY3009104).The study will be a multicenter, randomized, double-blind, placebo-cont
Briviact(ingredient: brivaracetam), a third-generation antiepileptic treatment, has obtained domestic approval.The new drug offers better and quicker absorption than existing medicines to alleviate seizures. The pharmaceutical industry is paying attention whether it will bring a change in the epilepsy treatment market in Korea.The Ministry of Food and Drug Safety granted the green light to
A recognized “bio expert” has recently become the director-general of the Biopharmaceuticals and Herbal Medicine Bureau at the Ministry of Food and Drug Safety (MFDS), raising high expectations among related industries.New Director-General Kang Seok-yeon, who took the bureau head’s post early this month, is a specialist who had accumulated experiences in the biotech field, including biopharmac
BioGenetics said it has signed a deal with Singapore-based drugmaker Aslan Pharmaceuticals to supply Aslan’s varlitinib, an investigational treatment for biliary tract cancer, exclusively in Korea.Under the deal clinched on Wednesday, BioGenetics gets an exclusive license on varlitinib in all indications, including colorectal cancer and breast cancer, in Korea.Established in 2010, Asla
Local drugmaker Chong Kun Dang won approval for clinical trials the most among pharmaceutical firms and medical institutions last year, government data showed.According to data from the Ministry of Food and Drug Safety, Chong Kun Dang won the regulatory nod for 25 clinical trial plans, followed by Seoul National University Hospital with 24, Novartis Korea with 22, Samsung Medical Center with 2
Korea and China agreed to strengthen cooperation for regulations on pharmaceutical products, medical devices, and cosmetic goods.Minister of Food and Drug Safety Ryu Young-jin signed a “memorandum of understanding on cooperation for regulations on drugs, cosmetics, and medical devices” with the National Medical Products Administration of the People’s Republic of China (NMPA) in Beijing, Monday
Korea’s 30th novel medicine K-Cab Tab. (ingredient: tegoprazan) will receive insurance coverage, eight months after winning approval, the government said. The gastric acid inhibitor will be reimbursable from March 1.The Ministry of Health and Welfare’s health insurance policy review committee set the price of K-Cab Tab. 50mg at 1,300 won ($1.16) per pill on Tuesday.For the drug pricing
The government said it would gradually scrap the “consigned bioequivalence test system,” which allows incompetent drugmakers to sell generic drugs by relying on another company to conduct bioequivalence tests.The authorities will limit the number of companies applying for joint bioequivalence tests to three, besides the first manufacturer of generic medicine, and entirely scrap the system thre
Local researchers said they confirmed the antiplatelet efficacy of Yuyu Pharma’s Yuclid (ingredient: ticlopidine, ginkgo leaf extract) in patients who underwent carotid artery stenting (CAS).Frontiers in Neurology, an international journal, published the study.The study aimed to compare the incidence of ischemic legions between patients with conventional therapy clopidogrel and the others
As Korea moves to allow medical marijuana imports for self-treatment purposes from March 12, the government reiterated that the Korea Orphan & Essential Drug Center (KODC) would be the only authorized importer.The Ministry of Food and Drug Safety held a briefing on the use of medical cannabis and raw materials at the Construction Management Training Center in Seoul, Thursday. Hyun Mi-y
The Ministry of Food and Drug Safety said it was pushing to amend the limited exclusive sales rights approval system, introduced in 2015, to help raise local drugmakers’ research and development capabilities. The ministry is reviewing the revision plan by collecting opinions from the pharmaceutical industry and referencing annual reports on the impact of the “patent approval linkage system.” I
The Ministry of Food and Drug Safety said it would conduct a regular inspection on 12 biopharmaceutical factories overseas that supply medicines for drugmakers in Korea.Kim Young-lim, director at the pharmaceutical standardization division at the National Institute of Food and Drug Safety Evaluation under the ministry, announced the plan at a government briefing on policies, approval, and lice
Pharma Research Bio said it obtained approval from the Ministry of Food and Drug Safety to export its botulinum toxin “Re N Tox” on Friday. The company has spent four years to develop the botulinum toxin A product. The government gave the green light to the company’s clinical trial plan in January. The latest export approval provides the drugmaker with an opportunity to conduct a trial and
The Ministry of Food and Drug Safety said it would build a state-run technological support center to help companies develop and commercialize local vaccines this year, as part of efforts to raise self-reliance of vaccines. Lee Yoo-kyoung, senior scientific officer at the biopharmaceutical policy division at the ministry, announced the government’s plan to attain the goal at a govern
The Ministry of Food and Drug Safety has allowed BMS Korea to conduct a phase-3 trial of Eliquis (ingredient: apixaban), an anticoagulant jointly developed by BMS and Pfizer, on pediatric patients in Korea.The study will be on children newly diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma (T cells or B cells). It will compare the safety and efficacy of Eliquis on one group to
The regulatory agency approved Rydapt 25mg (ingredient: midostaurin), a treatment for rare FLT3-mutated acute myeloid leukemia (AML), as an orphan drug. AML is the most common blood cancer in adults and mutations in specific genes such as FLT3 are found in many cases of the disease, according to Novartis.The Ministry of Food and Drug Safety on Thursday gave the nod to Rydapt in two indications
The World Health Organization is expected to change the diagnostic codes of personality disorder for the first time in 29 years in May.The WHO will hold the World Health Assembly in May to change the criteria of personality disorder diagnosis, during which it will present the new International Classification of Diseases (ICD-11), an updated version after the adoption of the ICD-10 in 1990.
Pfizer Korea said it voluntarily recalled some of Zyvox 600mg (ingredient: linezolid), an antibiotic to treat multidrug-resistant bacterial infections.After the market release, the company ran the stability test and found that dissolution test results of some of the products showed deviations from the domestic approval standards.The recalled products due to the abnormal dissolution res