The Ministry of Food and Drug Safety said it has ordered Dong-A ST to suspend the sale of 12 products and pay 21 million won fine ($18,880) for giving illegal rebates to physicians in return for drug promotions. The ministry on Friday revealed the administrative punishment on the drugmaker, which allegedly offered economic benefits to hospital operators and physicians.Because of illicit re
The Severance Hospital in Sinchon, Seoul, and Yongin Severance Hospital in Gyeonggi Province received administrative punishment for failing to keep the patient consent protocol.Asan Medical Center also received the government’s warning due to a delayed report on the unexpectedly significant drug adverse event during a trial.The Ministry of Food and Drug Safety on Tuesday gave a respective
The Ministry of Food and Drug Safety said Monday it would add precautions on three mercaptopurine-containing treatments and collect industry opinions until Oct. 2.The European Commission and the U.S. Food and Drug Administration recently disclosed safety information that mercaptopurine drugs showed high toxicity in patients with an infection, viral reactivation, and specific genes.Mercapto
The Ministry of Food and Drug Safety said it has given an administrative warning against AnC Bio and N&N Pharmaceuticals Asia for not submitting clinical trial status reports.AnC Bio failed to submit the status report on the phase-2, open-label, randomized, and multicenter study to assess cardiovascular effects and safety of “MyoCell,” implanted by a catheter delivery system in post-myocardial
Philips said it has found a reboot error in some Efficia DFM100 defibrillators used by physicians.The company reported to the Ministry of Food and Drug Safety that Efficia DFM100 models with a particular serial number stopped operation in an automated defibrillation mode and the system would reboot.As it takes about 23 seconds to reboot the system, defibrillators with the reboot error migh
Yuhan Corp. is to roll out a high-dose generic drug of Agrylin Cap. (ingredient: anagrelide) soon, after returning sales rights of Shire’s original drug. Yuhan’s generic copy is a second of its kind, with the first marketed by Pharmbio Korea.The Ministry of Food and Drug Safety on Thursday approved Yuhan to distribute Anagre Cap. 1mg for treating thrombocytosis from myeloproliferative disorder
Astellas has obtained the regulatory approval to go ahead with a global phase-3 clinical trial on investigational immunotherapy zolbetuximab in Korea.The Ministry of Food and Drug Safety said it has given the green light to Parexel Korea, a contract research organization, to conduct two tests as part of the phase-3 study in Korea, one in July and the other on Friday.Zolbetuximab is an expe
The government has ordered Pfizer Korea to halt imports of three drugs for one month, after detecting an abnormality in injection needles in Fragmin and foreign substances in Caduet and Lyrica.The Ministry of Food and Drug Safety on Thursday disclosed its decision on its website, ordering Pfizer Korea to suspend the imports of the three products for one month due to the violation of the Ph
Korea’s pharmaceutical output has exceeded 20 trillion won ($17.8 billion) for the first time, with biopharmaceuticals and raw drug materials driving up the growth, government data showed.According to data from the Ministry of Food and Drug Safety, the domestic production of pharmaceutical products reached 20.3 trillion won in 2017, up 8.3 percent from 18.8 trillion won in the previous year.
Boryung Pharmaceutical’s antihypertensive treatment Kanarb marked the largest production among 29 locally developed new drugs in 2017, government data showed Thursday.According to data from the Ministry of Food and Drug Safety, productions of novel drugs by domestic pharmaceuticals amounted to 184.8 billion won ($164.7 million) last year, up 10.1 percent from 167.8 billion won in 2016.
MSD Korea said it has won approval to sell an antidiabetic combination drug Steglujan (ingredient: ertugliflozin/sitagliptin) that mixed Steglatro (ertugliflozin) with Januvia (sitagliptin). Earlier in August, the company obtained the nod for Steglatro, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor.The Ministry of Food and Drug Safety on Wednesday gave the green light to sell Stegluj
The Korean government said it would prohibit the use of bisphenol A (BPA) in all food contact materials, containers and packages for infants and young children, instead of banning it in baby bottles only.The Ministry of Food and Drug Safety said Friday that it would put to public notice an amendment to the rules on standards for apparatus, containers, and packages to ban BPA in all food contai
The government said it has completed testing all valsartan-using hypertension drugs, following the recall of Chinese-made valsartan treatments due to a carcinogen risk.The Ministry of Food and Drug Safety found that Myungmoon Pharm’s Valsanin Tab. 80 mg had N-Nitrosodimethylamine (NDMA) which exceeded the acceptable level of 0.33 ppm in additional testing of 45 valsartan drugs. On Aug. 6, the
Daiichi Sankyo’s anticoagulant treatment Lixiana (ingredient: edoxaban) has faced a challenge by Korean drug firms seeking to avoid Lixiana’s substance and composition patents and release generic drugs.According to the Intellectual Property Trial and Appeal Board (IPTAB), Boryung Pharmaceutical, Hanmi Pharmaceutical, and Chong Kun Dang filed a request to confirm the scope of Lixiana’s substanc
TPLUS, a Korean healthcare solution provider, said it has obtained Europe’s CE Medical Device Directive certification for “View Vine,” a picture archiving and communications system (PACS).With the certification, the company can attach the CE mark on View Vine products sold overseas.European authorities issue the CE MDD only to medical products that pass strict standards for safety and
The Korean government has approved MSD’s Steglatro (ingredient: ertugliflozin l-pyroglutamic acids), the nation’s fifth sodium-glucose transport protein 2 (SGLT-2) inhibitor.The Ministry of Food and Drug Safety said it gave the nod to MSD Korea to sell the tablet as of Friday. Developed jointly by MSD and Pfizer, Steglatro is used as an aid to diet and exercise to improve blood sugar control i
Pfizer Korea and Bristol-Meyers Squibb Pharmaceutical Korea faced a one-month drug import suspension due to poor packaging.The Ministry of Food and Drug Safety said it suspended the two companies from importing Viviant Tab. 20mg (ingredient: bazedoxifene acetate) and Baraclude Tab. 0.5mg (ingredient: entecavir), respectively, for one month, starting on Monday.Pfizer Korea imported Vivi
Janssen Korea has obtained approval for clinical trials on plaque psoriasis treatment Tremfya (ingredient: guselkumab) to assess the drug’s efficacy for Crohn’s disease.The Ministry of Food and Drug Safety said it gave the green light to Janssen’s plan for phase-2 and phase-3 trials on guselkumab submitted on Aug. 9.The local trials will evaluate the efficacy and safety of guselkumab i
The government said it would ban 13 linear gadolinium contrast agents used for magnetic resonance imaging (MRI) tests until the end of this year.The Ministry of Food and Drug Safety’s ban came after Europe suspended the sales of the drug because of the possibility of accumulation of the gadolinium contrast medium in the brain.The ministry sent a Dear Healthcare Professional Letter (DHC
JW Pharmaceuticals has begun to develop a drug which combines two dyslipidemia treating tablets -- Livaro (Pitavastatin) and Ezetimibe. The Ministry of Food and Drug Safety approved on Monday the phase 1 clinical trial to evaluate the safety and pharmacokinetic properties of the combined use of Livaro(4mg) and Ezetrol(10mg). This clinical trial will be conducted for healthy male volunteers at