The Korean drug regulator is likely to nullify approval for Yoos Neurosolution (ingredient: ursodeoxycholic acid), a medicine that inhibits the progression of Lou Gehrig’s disease.However, the canceling of the license will have no impact on patients, as an alternative treatment is available, and no patient is taking the drug, observers said.According to the minutes of the Ministry of F
Five major local drugmakers celebrated the first working day of 2019 on Wednesday, with key goals for new drug development and sales growth. Following are their crucial management strategies for growth in 2019.Daewoong focuses on ‘responsible management’Daewoong Pharmaceutical said it would carry out “responsible management” this year to enhance customer value, accelerate development o
Choi Soo-bong, a professor at Konkuk University’s Graduate School of Medicine who developed an insulin pump, has come under fire for “gapjil,” abusing his power against employees of his company.Choi is the founder and CEO of Sooil Development Company, which manufactures insulin pumps used for diabetic patients. The company has about 100 employees with 10 billion won ($8.9 million) annual sales
The government ordered Withus Pharmaceutical to suspend manufacturing of Retonase Tab. (streptokinase/streptodornase) for three months, pointing to the company’s failure to run a quantitative test on the product.The Ministry of Food and Drug Safety on Thursday notified the administrative punishment on Withus Pharm on the ministry’s homepage.According to the ministry, Withus Pharm did n
Astellas Korea received administrative punishment for changing details of two clinical trials on a rheumatoid arthritis drug without regulatory approval.The Ministry of Food and Drug Safety on Tuesday ordered the company to suspend the two trials on “ASP015K,” a rheumatoid arthritis treatment, for 45 days, and patient recruitment for 45 days.ASP015K is a Janus kinase (JAK) inhibitor, drawi
The police caught a pharmaceutical firm bribing physicians by selling anesthesia drug propofol at a reduced price.The Seoul Metropolitan Police Agency said Tuesday it booked the CEO of the drugmaker and 30 others for the violation of the Pharmaceutical Affairs Act. The police also booked 32 physicians and four hospital employees for breaching the Medical Service Act and planned to refer them t
Handok said it would conduct a global phase-3 clinical trial to test Nemorexant, a follow-up treatment of insomnia drug Zolpidem, in Korea. The Ministry of Food and Drug Safety on Friday approved Handok’s plan for the trial, “ACT-541468A (Nemorexant).”The study will be a multicenter, double-blind, randomized, placebo-controlled, and parallel test to assess the efficacy and safety of ACT-541468
The nation’s stock market operator said on Friday it decided to delist Kyung Nam Pharm, a local drugmaker known for vitamin supplement Lemona.The Korea Exchange (KRX)’s corporate review committee said it evaluated the pharmaceutical firm’s plan to improve transparency, concluding the company’s management transparency was too problematic to keep the firm on the KOSDAQ market, the KRX said.I
Experts in robotic surgery around the world have gathered at the Severance Hospital in Seoul on Friday to participate in the International Robotic Surgery Live 2018 (IRSL 2018), a two-day conference.The Korean Endourological Society hosted the conference and the Severance Hospitals’ Robot & MIS (minimally-invasive surgery) Center organized the event. IRSL 2018 is the 12th international symposi
Handok said it has started developing a combination drug, mixing type-2 diabetes treatment Tenelia (teneligliptin) with dyslipidemia therapy atorvastatin. Tenelia is a dipeptidyl peptidase-4 (DPP-4) inhibitor.The Ministry of Food and Drug Safety approved Handok to conduct a phase-1 trial on the Tenelia combo, MP-513.The study will be a randomized, open-label, cross-design, and repeated
Medidata, a cloud-based solution provider for clinical research, said it has discovered a biomarker for a rare disease by using its machine learning solution.Biomarkers are indicators that objectively measure and evaluate drug response in target drug development.Medidata and the Castleman Disease Collaborate Network (CDCN) announced the discovery of the biomarker for Castleman Disease at t
Servier Korea received a warning from the Ministry of Food and Drug Safety after failing to comply with the management standard for imported medicines.According to the ministry, consumers filed complaints to the Korean unit of the French drugmaker that some of Vastinan MR Tab. (trimetazidine hydrochloride), an angina treatment, were found to have broken in press-through packages before opening
AbbVie said it would conduct a phase-3 clinical trial on upadacitinib, a treatment for rheumatoid arthritis, to evaluate its efficacy in ulcerative colitis in Korea.The Ministry of Food and Drug Safety on Thursday approved AbbVie Korea’s plan for the phase-3 study on ABT494 (upadacitinib). The trial will take place in multiple institutions including CHA Bundang Medical Center, Dong-A Universit
After Japanese women reported side effects of breast enlargement surgeries with fillers, the Ministry of Food and Drug Safety on Tuesday sent a warning letter to local doctors not to use unauthorized fillers.The warning went to the Korean Hospital Association, the Korean Medical Association, and the Korean Society of Plastic and Reconstructive Surgeons.In Japan, patients who underwent brea
AstraZeneca’s immunotherapy Imfinzi (ingredient: durvalumab) won domestic sales approval Tuesday, as the Ministry of Food and Drug Safety gave the nod to the company’s local offshoot to sell the therapy in Korea.As an injection inhibiting programmed death-ligand 1(PD-L1), Imfinzi received an indication for locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults, whose disea
Pfizer Korea said it won approval for Xeljanz Tab. 10mg (tofacitinib citrate) as a treatment for ulcerative colitis on Monday.The drugmaker released the drug as the first oral therapy for rheumatoid arthritis in Korea in 2015.Xeljanz drew attention as the first oral drug in the rheumatoid arthritis treatment market, which was led by injections such as Humira, Remicade, and Enbrel.T
Lilly said it would test its investigational breast cancer treatment Abemaciclib in patients with metastatic castrate-resistant prostate cancer in Korea.The Ministry of Food and Drug Safety approved Lilly Korea to conduct a phase-2 trial on LY2835219 Capsule on Tuesday.The study will administer either a combination of Abemaciclib with abiraterone acetate and prednisone or abiraterone aceta
Yuhan Corp. said it has developed a combination drug mixed Duowell (telmisartan/rosuvastatin) with amlodipine, for the simultaneous treatment of hypertension and dyslipidemia.The Ministry of Food and Drug Safety on Tuesday granted sales license to Yuhan for Duowell A (telmisartan/rosuvastatin/amlodipine).The combo medicine’s telmisartan and amlodipine lower blood pressure while its rosuvas
Philips Korea has entered the wireless ultrasound device market led by Healcerion. Industry watchers expect the two will inevitably clash with each other both here and abroad.The Korean offshoot of the Dutch healthcare firm held a news conference at its head office in Seoul Tuesday, to launch Lumify, a mobile application-based ultrasound machine. Philips introduced the device in the U.S. in 20
Domestic pharmaceutical companies have been competing to develop generic copies of Azilect (ingredient: rasagiline mesylate), the original treatment for Parkinson’s disease released by Lundbeck Korea in 2014.According to the Ministry of Food and Drug Safety, 13 drugmakers have won the approval for an equivalence test on their generic imitations of Azilect as of Monday.In April, Yuyu Pharma