Samsung Bioepis is speeding up to develop a biosimilar of Soliris (eculizumab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH).The Ministry of Food and Drug Safety on Wednesday gave the nod to the company to go ahead with a phase-3 trial that compares Samsung Bioepis’ biosimilar candidate SB12 withAlexion Pharmaceuticals’ original drug Soliris. Soliris obtained local app
Korea’s drug regulator said it has found many advertisements that either promoted groundless therapeutic effects of treating and preventing hair loss or used online reviews to promote products illegally.The Ministry of Food and Drug Safety Ministry said it caught 2,248 cases of illegal ads claiming therapeutic and preventive effect for hair loss on online ad sites for foods, drugs, and cosmeti
An increasing number of pharmaceutical companies voluntarily canceled the license for their products in the first six months this year, apparently affected by the latest regulation mandating drugmakers to update clinical data to maintain drug approval.According to the Ministry of Food and Drug Safety, drug companies sought voluntary license nullification on 1,583 medicines from January to June
The Ministry of Food and Drug Safety and Celltrion said rumors about the drugmaker giving up on the local release of HIV treatment Temixys (tenofovir disoproxil fumarate/lamivudine) were not true.News reports had said Celltrion delayed the application for approval in Korea because the ministry asked the biosimilar maker to submit phase-3 local trial data. The company recently won the U.S. Food
Pfizer Korea’s renal cancer treatments Sutene Cap. (ingredient: sunitinib malate) and Inlyta Tab. (axitinib) will add precautions for pregnant and nursing women, the government said.The Ministry of Food and Drug Safety on Thursday said it would order the company to change the two drugs’ caution labels based on the latest safety information from Canada, and receive the company’s opinions by Jul
LSK Global PS said it has obtained an international certification for clinical data management from the Society for Clinical Data Management (SCDM), a non-profit group, for the first time as a local contract research organization (CRO).The certification recognizes the company as one of the Certified Clinical Data Manager (CCDM®) Industry Partners. Among 2,200 members of SCDM, only 17 companies
Daewoong Pharmaceutical said it has begun developing a rheumatoid arthritis drug, as the Ministry of Food and Drug Safety on Tuesday approved the plan for a phase-1 clinical trial on the investigational treatment DWJ1421.The study will be a randomized, open, single-dose, cross-design trial to compare the safety and pharmacokinetic traits of DWJ1421 and DWC201903 in 40 healthy adult male volunt
The Ministry of Food and Drug Safety recently confirmed that Kolon Life Science fabricated data to win approval for the world’s first gene therapy Invossa-K. However, the regulator will not be free from charges of neglect of duty, observers said.The ministry on Tuesday revoked Invossa license after confirming that the company had manipulated data submitted for the drug review. It also plans to
The Ministry of Food and Drug Safety said there was no significant concern for patients who received Invossa-K injections because kidney-derived cells in the second fluid of the drug died 44 days after a cell death test.The ministry said it conducted a cell death test from April 11 to May 26 and found that the cells did not exist 44 days after the test.“In our test, we confirmed that all o
W.L. Gore & Associates, the sole provider of artificial blood vessels for pediatric heart surgeries, has agreed to supply 11 models of vessels and three models of cardiovascular patches in Korea.The Ministry of Food and Drug Safety said on Thursday that the U.S. manufacturer decided to provide four additional models of vessels and three models of cardiovascular patches, as previously requested
The Ministry of Food and Drug Safety said additional material submitted by Kolon Life Science was not convincing enough to clarify how Invossa-K’s cell ingredient was mislabeled.The ministry said it would have to combine the results of the inspection into Kolon TissueGene in the U.S. and the ministry’s direct analysis of Invossa to find out the details about the mislabeling. Ear
A delegation of the Ministry of Food and Drug Safety left for the U.S. on Sunday for a weeklong inspection of Kolon TissueGene to check how the cell ingredient of osteoarthritis gene therapy Invossa-K was mislabeled. The delegation is scheduled to return to Korea on next Sunday.The regulator dispatched more than 10 officials as the inspection team, about five times the average size of an inspe
Starting hyperlipidemia treatment, even at the age of 75 or later, can lower the risk of cardiovascular disease, a local study showed.A research team, led by Severance Hospital Cardiology Professor Lee Sang-hak, found that hyperlipidemia drug statin reduced the chance of cardiovascular disease among the elderly aged 75 or more by 41 percent, and mortality by 44 percent. The study has been
Yonsei University Health System (YUHS) said it would set up a hospital medicine department consisting of hospitalists, for the first time in Korea.Hospitalists are physicians directly providing care for inpatients with their services ranging from hospital admission to discharge. The introduction of hospitalists began with the Medical Residents Act in December 2017. Hospitalists act as attendin
Celebrating its fifth anniversary this year, Yonsei Cancer Center vowed to provide patient-centered care and treat more intractable cancer.Keun Ki-chang, president of Yonsei Cancer Center and a professor of radiology and oncology, said the hospital has achieved the quantity growth to the fullest, with the number of patients and wards reaching the maximum.“Now is the time for quality gr
The Ministry of Food and Drug Safety is likely to decide in mid-May on when it will visit U.S.-based Kolon TissueGene for inspection over how the main ingredient of Invossa-K was mislabeled for over a decade.The ministry and Kolon Life Science, the parent company of Kolon TissueGene, are reportedly in talks to finalize the schedule. It is highly likely that the decision will come after May 15,
Korea’s medical devices and related materials output surpassed 6 trillion won ($5.17 billion) for the first time in 2018.According to the Ministry of Food and Drug Safety, the production of local medical devices expanded 11.8 percent last year, compared to a year earlier, on robust sales growth of dental implants, ultrasound imaging devices, and cosmetic fillers.Dental implants marked 1.07
The most shocking news in the biotech industry in the first half was the mislabeling of osteoarthritis therapy Invossa-K by Kolon Life Science.Physicians have used the treatment, trusting the data confirmed by the regulator after clinical trials. However, one of the drug ingredients has been mislabeled the whole time, appalling everyone – the drugmaker, the regulator, and patients. Mor
The drug authorities have banned the use of dioctahedral smectite-containing drugs for acute diarrhea for children aged 2 or less, pregnant and nursing women, due to safety issues.If the child is aged over 2, the medication period will be limited to seven days maximum.The Ministry of Food and Drug Safety on Tuesday issued a safety letter over eight authorized pharmaceutical products in
Eye irritation test developed in Korea has won the approval as the test guideline of the Organization for Economic Cooperation and Development (OECD). The designation was the world’s fourth, after the U.S., France, and Japan, recognizing it as an alternative to an animal experiment for eye irritation.Conventional eye irritation tests use rabbits to check the possibility of eye irritation. Howe