The Ministry of Food and Drug Administration said it has approved Dong-A ST to conduct a phase-2b trial on DA-8010, an investigational drug for overactive bladder.The study will be a therapeutic and exploratory trial on local 300 patients with an overactive bladder to confirm the treatment’s efficacy and safety.The trial will take place at Samsung Medical Center, Asan Medical Center, Sever
Daewoong Pharmaceutical is actively promoting Nabota, an injectable type A botulinum toxin, by presenting its latest clinical results at academic events in the U.S. and Mexico.The Korean drugmaker revealed the results of the comparative studies on Nabota and original treatment Botox, at the meeting of the American Society for Aesthetic Plastic Surgery in New York from Thursday to Tuesday.T
Sanofi-Aventis Korea said it would start phase-3 clinical trials (SAR439954) in Korea to check safety and tolerability of Sotagliflozin, a treatment for type-2 diabetes inhibiting SGLT (sodium-glucose transport proteins) 1 and 2.The Ministry of Food and Safety granted the nod for the study plan on Wednesday.The trials will be randomized, double-blind, placebo-controlled, parallel arm, and
Local pharmaceutical experts said the health authorities did not have to switch extended-release (ER) acetaminophen products to prescription drugs in the wake of the European Medicines Agency’s suspension of marketing such treatments. Popular modified-release acetaminophen (paracetamol) medicines include Tylenol and Panadol. According to the minutes of the Ministry of Food and Drug Safety’
Patent applications for smart wheelchairs using brain-machine interface (BMI) technologies have surged in the past five years between 2012 and 2017, government data showed. BMI and related sensors allow wheelchairs to recognize biometric information such as voice or brain waves.According to the Korean Intellectual Property Office (KIPO), the number of patent requests for smart wheelchairs spik
The Ministry of Food and Drug Safety (MFDS) on Wednesday said it would amend regulations to allow orphan drug designation on approved clinical trials.An orphan drug refers to a rarely used medication for treatment of a rare disease without an alternative, requiring an urgent market release. The amendments will support a quick development of treatments for rare and incurable diseases, the gover
An international pharmaceutical exhibition opened at the Korea International Exhibition and Convention Center (KINTEX) in Ilsan on Tuesday, showcasing latest raw materials and finished products.The Korea Pharm & Bio 2018, an eighth edition of the business-to-business exhibition, was hosted by the Ministry of Food and Drug Safety and the Korea Pharmaceutical and Bio-Pharma Manufacturers Associa
Korea’s output of medical devices expanded 3.9 percent year-on-year to mark 5.82 trillion won ($5.44 billion) last year, boosted by an increase in dental implant-related products and anti-wrinkle fillers, government data showed Tuesday. According to data from the Ministry of Food and Drug Safety, the nation’s exports of medical devices amounted to 3.57 trillion won in 2017, up 8.2 percent com
Janssen Korea said it has launched a follow-up drug of psoriasis treatment Stelara (ingredient: ustekinumab).The Ministry of Food and Drug Safety on Thursday approved Tremfya Prefilled Syringe Inj. (ingredient: guselkumab).Tremfya Prefilled Syringe received the indication for the treatment of moderate to severe adult scleroderma requiring phototherapy or systemic therapies.After the fi
Hanmi Pharmaceutical is expected to discontinue developing lung cancer treatment Olita (ingredient: olmutinib) amid canceled licensing deals with drugmakers overseas, the government said Friday.The Ministry of Food and Drug Safety said the Korean pharmaceutical firm submitted a plan to end the development of Olita 200mg and 400 mg.Hanmi had to drop the drug due to cancellations of licensin
LG Chem said it has won approval from the Ministry of Food and Drug Safety on Wednesday to go ahead with a phase-1 clinical trial on “EV-81,” an investigational drug combining three agents to treat hypertension and dyslipidemia. The study will be on 42 healthy males at Seoul National University Hospital, checking the safety, tolerability, and pharmacokinetic interactions of the combination
The government said Tuesday Il-yang Pharmaceutical’s Supect (ingredient: radotinib) would lose its second-line indication for treatment of chronic myelogenous leukemia.The medicine had obtained approval as a second-line treatment for patients with chronic myelogenous leukemia who do not respond to conventional therapies, on the condition that the drugmaker conducts a clinical study to confirm
Medical device manufacturers’ plans for clinical trials on filler development won the most regulatory nods last year, government data showed Wednesday.According to the Ministry of Food and Drug Safety, the number of approved clinical trials for fillers was eight, the highest among the total of 84 approvals for studies on medical devices in 2017.The rising overseas demand for anti-wrinkle f
Janssen Korea will have to increase the number of post-marketing surveillance (PMS) cases to 3,000 regarding the sales of schizophrenia drug Invega Sustenna Inj. and Invega Trinza Inj. (ingredient: paliperidone palmitate), the government said Monday. According to the minutes of the Ministry of Food and Drug Safety (MFDS)’s central pharmaceutical affairs advisory committee on Feb. 23, Janssen K
Korean cancer patients will be able to receive a state-of-the-art heavy ion therapy at Severance Hospital as early as in 2022.Yonsei University Health System (YUHS) signed a contract with Toshiba Energy Systems & Solutions and DK Medical Solutions to adopt Toshiba’s heavy ion therapy system at Yonsei University in Seoul, Thursday.Heavy ion therapy is considered the best cancer treatment av
Hanmi Pharmaceutical has obtained approval to test a combination therapy of four medicines, the first of its kind, to treat hypertension and hyperlipidemia.The Ministry of Food and Drug Safety on Tuesday gave the nod to the drugmaker’s plan to carry out a phase-1 clinical trial on the agent called “HCP1701.”The study will evaluate pharmacokinetic/pharmacodynamic interactions and safety in
The pharmaceutical industry is paying attention to whether Lenabasum, an investigational drug to treat systemic sclerosis, cystic fibrosis, and dermatomyositis, will arrive in Korea.The Ministry of Food and Drug Safety on Monday gave the nod to EPS International Korea, a contract research organization (CRO), to go ahead with its plan for a phase-3 local clinical trial for JBT-101, known as Len
Samsung Medical Center obtained the most approvals for clinical trials in the Korean pharmaceutical and healthcare sector last year, government data showed.The Ministry of Food and Drug Safety on Thursday said Samsung Medical Center received 32 regulatory nods in 2017, followed by multinational contract research organization (CRO) Quintiles Transnational Korea with 26, Seoul National Universit
Jointstem, a stem cell therapy for degenerative arthritis, failed to obtain conditional approval. The therapy is an autologous adipose-derived mesenchymal stem cell injection, developed by Nature Cell.The Ministry of Food and Drug Safety (MFDS)’s Central Pharmaceutical Affairs Council reviewed giving the nod to Jointstem at a meeting on Tuesday. However, the ministry said it concluded that Nat
Revo-i, the first locally developed laparoscopic surgical robot, is about to challenge foreign rivals that have dominated the surgical robot market in Korea.Meere Company, the developer of the machine, held a launching ceremony at Vista Walkerhill Seoul on Wednesday, inviting hospital officials and physicians.Revo-i obtained approval from the Ministry of Food and Drug Safety in August last