China will carry out customs inspection on Korean chemical medicines only once at the initial stage and exempt them from inspections thereafter, the Korean government said.As it took about two to four weeks for Korean chemical drugs to go through Chinese customs, the new measure will significantly reduce the customs time.The Ministry of Food and Drug Safety and the Korean Agency for Techno
The Ministry of Food and Drug Safety plans to fix up problems caused by the reckless production of generic medicines, devising up measures to overhaul the drug approval system within this year.Kim Sang-bong, director of the ministry’s Pharmaceutical Policy Division, said the renewing of the approval system would involve three aspects – R&D, exports, and distribution market order.He said th
The Ministry of Food and Drug Safety approved MSD Korea to conduct a phase-3 clinical trial on Lynparza (olaparib), targeted therapy for ovarian cancer, to test a maintenance therapy.A maintenance therapy helps a primary treatment succeed and prevent a relapse.The study will evaluate a maintenance therapy using olaparib or placebo, after the first-line treatment of Lynparza plus Keytruda o
Half of the cosmetic products that claimed to block the skin from fine dust did not have the effect, the regulator said.The Ministry of Food and Drug Safety said it has tested 53 products, including sunscreens, moisturizers, and cleansers, which had claimed that they could block or cleanse fine dust.The result showed that 27 of them did not work, the ministry said Tuesday.The ministry’
The Ministry of Food and Drug Safety said it would recall the entire batch of percutaneous BCG vaccines imported from Japan, as Japan’s Ministry of Health, Labor and Welfare ordered to suspend shipments of the BCG vaccines.A BCG vaccine prevents tuberculosis and is given to almost all newborns in Korea.Japan’s health ministry said it detected an excessive level of arsenic in physiological
Anticancer treatment developer Well Marker Bio said it has completed the so-called “Series-A” funding to raise 28 billion won ($25 million), six months after raising 4.5 billion won seed funding in April. Series-A funding refers to the first round of financing of around 1 billion won, which a startup company receives from a venture capital after two to five years since the company’s foundation
CJ HealthCare is seeking to add an indication for the eradication of Helicobacter pylori to K-Cab Tab. (tegoprazan), a treatment for gastroesophageal reflux disease (GORD). Helicobacter pylori are a type of bacteria, causing ulcers in the digestive tract.The Ministry of Food and Safety said it has approved the drugmaker to conduct a phase-1 trial regarding the indication.In the study, the
LG Chem said it would start developing bilayer tablets of Zemiro (gemigliptin, rosuvastatin), a combination drug that simultaneously treats diabetes and dyslipidemia, for better drug stability. Bilayer tablets have less physicochemical interactions between the two different ingredients because of the separation of the two, offering higher stability and longer storage time. LG Chem said bilayer
The Ministry of Food and Drug Safety ordered a recall of “Raindrop Near Vision Inlay” due to reports of corneal haze caused by inflammation in patients who received the inlay treatment to correct near vision.The ministry said it found the U.S. Food and Drug Administration’s updated safety information on the risky medical device and notified the recall to the Korean Hospital Association, the Ko
The government should amend the healthcare system to use more biologic medications to treat psoriasis, one of the autoimmune diseases, an expert said.Song Hae-jun, president of the Korean Society for Psoriasis (KSP), said physicians should have more discretion to use biologic drugs, at a news conference at the Plaza Seoul on Monday, celebrating the World Psoriasis Day. Song works at Korea Univ
Novo Nordisk said it would conduct phase 3a clinical trial for Ozempic in Korea, too. Ozempic is a semaglutide, the company’s new GLP (glucagon-like peptide)-1 analog and a drug to treat type 2 diabetes through a weekly dose.The Ministry of Food and Drug Safety has approved the 3a clinical test for “semaglutide” (for injection) applied by Novo Nordisk Korea. The upcoming clinical trial
The Ministry of Food and Drug Safety issued a warning to Ono Pharma Korea for late reporting of the grave and unexpected adverse reactions during a clinical trial on nivolumab, a medication to treat cancer.According to the ministry, the pharmaceutical firm reported two days later that a patient, participating in the trial on “ONO-4538” (ingredient: nivolumab), was hospitalized due to urinary t
Daewoong Pharmaceutical said it obtained regulatory approval to conduct a phase-3 clinical trial next-generation antiulcer drug, “DWP14012.” The drugmaker aims to win sales license for the treatment by 2020.The new antiulcer therapy draws attention as an agent to replace proton-pump inhibitor (PPI) medicines, which reduce stomach acid production. The phase-3 trial will evaluate the efficacy an
The operating profit to sales ratio of 110 pharmaceutical companies listed on the Korean stock market stood at 12.2 percent in the first half of this year, down slightly from 12.7 percent a year earlier.In other words, they earned 122 won ($0.11) profit out of 1,000 won ($0.88) revenue on average in the first six months, government data showed. Operating margin, a measure of profitability, can
Members of the National Assembly’s Health and Welfare Committee criticized the Ministry of Food and Drug Safety (MFDS) for insufficient follow-up measures after the recall of risky hypertension drugs.Earlier, the government ordered drugmakers to stop selling valsartan medicines that contained N-nitrosodimethylamine (NDMA), a carcinogen. The ministry has completed the rollback of 147 out of the
Bristol-Myers Squibb is soon to conduct phase-2 trials in Korea on its immunotherapy, cabiralizumab, which treats pancreatic cancer.The Ministry of Food and Drug Safety on Wednesday gave the green light to BMS Korea to test BMS-986227 in a phase-2, global, multi-center study.Five Prime, a San Francisco-based biotech firm, developed the investigational immunotherapy and gave BMS exclusive g
The government ordered Korea Abbott to recall its hepatitis B antibody reagent amid concerns that some of the products could show inaccurate test results.The reagent tests whether a person had been infected by current or past hepatitis B virus by checking the antibody to he patitis B in the serum.The Ministry of Food and Drug Safety said it ordered Abbott to recall automated immunoassa
The government said it would change approval conditions for two pharmaceutical products that use amantadine sulfate as the main ingredient, due to lack of evidence in drug safety and efficacy.The decision follows the government’s review of safety and efficacy every five years whether to extend the approval conditions.The Ministry of Food and Drug Safety said on Friday that it would delete
Allergan is recalling Ozurdex Intravitreal Implant 700㎍ (ingredient: dexamethasone), a steroid eye implant for macular edema, after detecting a foreign substance in some productsThe Ministry of Food and Drug Safety said it confirmed that imports of Ozurdex products contained a foreign material.Ozurdex is implanted in the vitreous of the eye to treat macular edema following branch retin
Bristol-Myers Squibb said it would begin global phase-3 trials on BMS-986165, an investigational drug for psoriasis, in Korea.Unlike conventional psoriasis, BMS’ new treatment comes in an oral form. BMS-986165 has been drawing particular attention after it showed positive results in a phase-2 study in September.The Ministry of Food and Drug Safety on Friday gave the nod to BMS to go ahead