Hanmi Pharmaceutical said Wednesday that the company recently won the approval of the Ministry of Food and Drug Safety for its first combination drug to treat patients who have both asthma and allergic rhinitis.Hanmi한미약품’s Monterizine몬테리진 is the combination of Montelukast (10g), a component that alleviates asthma and rhinitis symptoms by inhibiting leukotriene substances, and Levocetirizine HC
It’s only natural a drugmaker that has developed a new innovative therapy goes all out to win its marketing approval and listing as the insurance-covered medication in major markets.That also explains why the U.S. pharmaceutical company Merck Sharp & Dohme (MSD) is keenly interested in the Korean government’s process to include its new immunotherapeutic anti-cancer drug Keytruda (compound: pem
Roche’s Tecentriq (compound: atezolizumab), the first immunotherapeutic bladder cancer treatment approved by the U.S. Federal Drug Administration, has failed Phase 3 clinical trials, the company said.Since Roche won the accelerated approval by the results of Phase 2 trials of Tecentriq, the recent failure will make it difficult for the Swiss company to maintain FDA’s approval for Tecentriq, in
Celltrion has secured additional grounds for its biosimilar Remsima, called Infliximab in the United States, targeting the world’s largest pharmaceutical market.The Korean biopharmaceutical company said Wednesday that it had obtained the results of phase 3 clinical trials and observational studies of Remsima, in comparison with the original drug, Johnson & Johnson’s Remicade, on the patients o
The U.S. Food and Drug Administration granted accelerated approval Tuesday to Bavencio, also called Avelumab, for patients suffering from advanced or metastatic urothelial carcinoma.Bavencio is targeting patients with the disease which progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.The accelera
Pharmacies around the globe are retailing two categories of drugs: Over the Counter (OTC) drugs, which are medications sold directly to consumers; and prescription medicines that require medical prescriptions to be dispensed.What will happen, however, if a customer desperately needs non-OTC drugs at midnight when clinics and pharmacies are closed until the next morning?This is why the Mini
Biomarin Pharmaceutical won the go-ahead from the U.S. Food and Drug Administration Thursday for Brineura (cerliponase alfa), the first treatment for children who suffer from the Batten disease.The Batten disease causes mental impairment, seizures, and progressive loss of sight, speech and motor skills.Brineura is an enzyme replacement therapy to slow down the loss of walking ability in sy
The U.S. Food and Drug Administration Thursday expanded the approved use of Stivarga (regorafinib) for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer.This is the first FDA-approved treatment for a liver cancer in almost 10 years. The FDA granted the approval of Stivarga to Bayer HealthCare Pharmaceuticals Inc.According to the National Cancer Institute, a
The top 10 diseases have shifted from communicable to non-communicable sicknesses such as strokes and asthma, thanks to the worldwide use of antibiotics and vaccines as well as improved living standard, an expert said Wednesday.Medicine and technologies, particularly biotherapeutics and biosimilars, are expected to play a significant role in the treatment and care of many non-communicable dise
An Italian doctor and his team are about to perform one of the most talked-about surgeries -- technically and ethically -- in December.In what will be the world’s first full-body transplant, Sergio Canavero and a multinational group of surgeons are to attach the body of a brain-dead donor to the head of a paralyzed patient to make the patient walk again. The brave patient is a Russian comp
The U.S. Food and Drug Administration (FDA) posted warning letters on Tuesday to 14 U.S.-based companies, which are illegally selling more than 65 products that falsely claimed to prevent, diagnose, treat or cure cancer.All products are marketed and sold mostly on websites and social media platforms without FDA approval.“Consumers should not use these or similar unproven products because t
SillaJen신라젠, a Korean developer of bio drug, said Monday the first European patient been enrolled in its multinational Phase 3 trial for Pexa-Vec in advanced liver cancer, also known as hepatocellular carcinoma (HCC).According to the contract with Transgene, a French pharmaceutical company, SillaJen will receive a $4-million milestone from Transgene. The patient was enrolled at Azienda Osp
Koreans work hard. They are second-hardest working people among OECD nations -- with 2,113 hours a year as of 2015. Koreans engaged in some occupations work even far harder than others, however. Among such jobs are pharmacists. According to a survey, the annual working hours of druggists amounted to 3,232 hours, 1,119 hours longer than the national average. If their monthly or bimonthly Sun
The U.S. Food and Drug Administration (FDA) Thursday advised against the use of two narcotic painkillers – codeine and tramadol – on children under 12 and nursing mothers.Codeine and tramadol are a type of narcotic medicine called opioid. Codeine is used to treat mild to moderate pain and to reduce coughing. It is frequently combined with other drugs in prescription and over-the-counter (OTC)
Daewoong Pharmaceutical대웅제약 has launched its generic antibiotic “Meropenem” in the United States, the company said Wednesday.Meropenem is Daewoong's first product exported to the American market and the first Korean generic drug sold the world’s largest medicine market. It won the approval of the U.S. Food and Drug Administration in December 2015 and will be sold there in earnest beginning thi
“Give the disease and offer the remedy,” an old Korean saying goes, which is somewhat similar to “carrying fire in one hand and water in the other.” However, some pharmacies in this country still give the ailment and drug at the same time – literally. According to the estimation by Korean Pharmacists' Association (KPA), some 100 pharmacies or so might still be selling cigarettes, displaying to
Eli Lilly and Co. and Incyte Corp. said Friday that the U.S. Food and Drug Administration (FDA) dismissed their request to approve baricitinib, the treatment of rheumatoid arthritis (RA), as a new drug.The FDA indicated that it needs additional clinical data to determine its proper doses and to characterize safety concerns better. Eli Lilly said the Indianapolis-based company and its partner d
Modern, efficient data management not only benefits doctors and patients in overseeing individual cases but also promises a wealth of data that can be anonymized and aggregated for analysis and diagnosis.Which is why healthcare experts such as David Hansen, CEO of the Australian e-Health Research Center, stresses the importance of the role of information and communication technologies in digit
Hanyang University Hospital will hold its annual international symposium on the rheumatic disease on May 18, hospital officials said Friday.The symposium, which meets its 19th anniversary this year, will serve as a platform for discussing the current situations and challenges concerning clinical and translational research in systemic lupus erythematosus (SLE), they said.About 30 internatio
Korean and Italian pathological experts agreed on the need Tuesday for making the most of “personalized medicine” to ensure a higher quality of life and more efficient use of healthcare resources. Personalized medicine, also called precision medicine, is a medical procedure that separates patients into different groups—with medical decisions, practices, interventions and/or products being tai