The government has accepted Bayer’s request to reduce the number of review cases of Stivarga (ingredient: regorafenib), a gastrointestinal stromal tumor (GIST) treatment, from 3,000 to 300 for the drug reevaluation. The Ministry of Food and Drug Safety held a meeting of the central pharmaceutical affairs advisory committee on Jan. 10 to decide whether to cut the number.Bayer won the
Fourteen pharmaceutical firms are to roll out generic copies of Stillen 2X Tab. (ingredient: Artemisia herb 95 percent ethanol soft ext. (20→1)), a gastritis treatment, early this month. Stillen 2X developer Dong-A ST began to market the treatment in 2016. The tablet improved the patient compliance and convenience by reducing the dosing from three times a day to twice a day.The 14 drug
The government is likely to add a warning in the instructions of pseudoephedrine-containing medicines that severe skin adverse reactions such as acute generalized exanthematous pustulosis (AGEP) might occur. Pseudoephedrine is used to relieve symptoms of cold or rhinitis.After the European Medicines Agency’s latest warning of AGEP to pseudoephedrine-using drugs, the Ministry of Food and Drug S
Korea used 4.74 billion won ($4.24 million) to compensate the damages such as death, disability, and disease caused by side effects of authorized drugs in the past four years, government data showed.The Ministry of Food and Drug Safety said it received 350 applications for compensation and approved 220 cases since the ministry introduced the compensation system in December 2014. Among them
The government will not allow renewal of drug approval if a company manufactures medicines only to maintain the license without sales. Lee Dong-hee, director general of planning and coordination bureau at the Ministry of Food and Drug Safety, said that the ministry would consider a drugmaker’s insurance claim records when reviewing a renewal of approval for medicine, at a news conference
The Ministry of Food and Drug Safety said it would enhance drug safety management and make a new review process for advanced healthcare goods. The ministry announced its yearly administrative plan at a news conference in Osong, North Chungcheong Province, Monday.The ministry’s annual plan emphasized managing the safety of pharmaceutical products and medical device and supplying necessary i
The Supreme Court recently ruled that drugmakers’ alteration of an original medicine’s base to make generic copies was a patent infringement. The decision apparently dealt a major blow to local firms to use the base-altering strategy as a means of avoiding patents.However, four domestic pharmaceutical firms said they won limited exclusive rights to sell their generic copies of Pradaxa (dab
The Ministry of Food and Drug Safety issued a warning to two clinical research organizations (CRO) for late reporting of adverse drug events. The two are Pharmaceutical Product Development (PPD) and ICON Clinical Research.PPD was conducting a trial to test immunotherapy called “ONO-4538,” and ICON Clinical Research, a treatment for B cell lymphoma “MOR00208.” Both received the warning because
The Patent Court of Korea has rejected Jazz Pharmaceuticals’ application for registering its acute myeloid leukemia (AML) treatment Vyxeos (ingredient: daunorubicin/cytarabine).The court confirmed the original decision of the Intellectual Property Trial and Appeal Board (IPTAB) that rejected the Irish company’s request to register Vyxeos’ patent through its subsidiary Celator Pharmaceuticals.
Gilead Sciences said it has obtained approval for Biktarvy, a three-in-one single combination drug for the HIV (human immunodeficiency virus) treatment. Its ingredients are bictegravir, emtricitabine, and tenofovir alafenamide.The Ministry of Food and Drug Safety granted the nod for the medicine on Friday.Biktarvy enhanced the efficacy by adding bictegravir, an integrase strand transfe
The chief of Korea’s representative biopharmaceutical industry group called for the government’s full support for the sector, calling the pharmaceutical business “the future of Korea.”Won Hee-mok, chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), said the government has been treating the pharmaceutical sector as something to be regulated, even though it is
The government recognized Pharma Research Products’ intra-articular injection Conjuran as a new medical technology.The Ministry of Health and Welfare said Tuesday it has included the product in the list of new medical technologies, notifying the safety and efficacy of “intra-articular injection using polynucleotide sodium.”The product can help relieve pain and improve joint function by red
The government ordered Baxter to suspend the sale of Theranova, a blood filter for artificial kidney, for 15 days because of a comparative advertisement where the company said its hemodialyzer was better than other competitors.The Ministry of Food and Drug Safety made the instruction on Monday, mandating the sales suspension of Theranova for 15 days from Wednesday to Jan. 30.Released in Ko
Five local drugmakers have obtained approval for medicines that changed the dosing of Pfizer’s Lyrica (ingredient: pregabalin), a neuropathic pain reliever, from twice daily to once daily.The Ministry of Food and Drug Safety on Friday allowed LG Chem, Hanlim Pharmaceutical, GL PharmTech, Daewon Pharmaceutical, and Crown Pharm to sell nine sustained-release products that used pregabalin as
Fourteen pharmaceutical companies are likely to roll out generic drugs that copied Stillen 2X Tab., a gastritis treatment, in early February. The companies had won limited exclusive rights last year to sell their generic copies for nine months without any other competitors.Stillen 2X developer Dong-A ST improved the usage of the acute and chronic gastritis drug Stillen by reducing the dosi
Dongkoo Bio & Pharma said it would conduct a clinical trial to expand the treatment scope of “Smart X,” an autologous stem cell therapy developed by the company.The study will evaluate the efficacy and safety of autologous stromal vascular fractions (SVF) in patients with diabetic foot ulcers. The trial will take place at the Catholic University of Korea Seoul St. Mary's Hospital and Keimyung
MSD Korea said it would recall HIV treatment Stocrin (ingredient: efavirenz) manufactured with a particular code.The Ministry of Food and Drug Safety said it ordered the pharmaceutical firm to withdraw Stocrin 600mg with the factory number “86735023” and the expiration date April 27, 2021.The decision came as the ministry found that the company distributed the HIV drug without adding a war
The Korean stock market operator decided to keep Kyung Nam Pharm listed on KOSDAQ, reversing its earlier decision to delist the firm due to accounting violations. The local drugmaker is known for vitamin C supplement Lemona.The regulator ordered Kyung Nam to improve management transparency during a one-year grace period. The Korea Exchange (KRX) will decide on whether to delist the firm a year
Korean pharmaceuticals Handok and Genexine said they have jointly become the largest shareholder of Rezolute, a U.S. biopharmaceutical firm.The two companies owned 54 percent stake in Rezolute as of Monday, by jointly investing $25 million in the U.S. firm. Established in 2010, Rezolute specializes in developing innovative drugs for metabolic and orphan diseases.The U.S. biotech firm is so
The Korean government has approved a phase-3 clinical trial to evaluate the efficacy and safety of a new influenza treatment baloxavir marboxir (product name: Xofluza).The Ministry of Food and Drug Safety on Wednesday gave the nod to check whether would be safe and effective to use baloxavir marboxir in patients hospitalized with severe influenza, compared to the standard treatment using neura