Celltrion said that it has submitted a marketing authorization application (MAA) of Regkirona, a Covid-19 treatment, to the European Medicines Agency (EMA) last Friday.“The indication target is adult patients 18 years of age or older confirmed with Covid-19 who do not require supplemental oxygen sup
Sudanese Minister of Investment and International Cooperation Al-Hadi Ibrahim and Industry Minister Ibrahim al-Sheikh visited Shinpoong Pharmaceutical last Friday to discuss the company’s role in developing the African country’s pharmaceutical industry.During the visit, the two ministers toured the
Spectrum Pharmaceuticals, a U.S. partner company of Hanmi Pharmaceutical, will hold a Type-A meeting with the FDA to win approval for Rolontis (eflapegrastim), a treatment for neutropenia.Through a Type-A meeting, a company can take the feedback from the FDA and address issues impeding drug approval
The Korean Society for Laboratory Medicine (KSLM) expressed concerns over the increasing number of people purchasing home antibody kits at pharmacies and taking Covid-19 antibody tests.Home antibody tests are inaccurate and ineffective, and they can evaluate neither a person’s immunity against the C
The K-Hospital Fair has completed its three-day event, introducing various sustainable, innovative digital healthcare solutions amid the prolonged Covid-19 pandemic and accelerating the digitization of the healthcare industry.Many Korean and foreign biotech companies developing digital healthcare so
CartiLife, an autologous cartilage-derived chondrocyte cell therapy for regenerating knee cartilage, will be easier to inject with a new injector, industry officials said.CartiLife won a conditional nod from the Ministry of Food and Drug Safety in April 2019 to treat knee cartilage defects (ICRS Gra
The domestic botulinum toxin (BTX) drug market is going through significant changes in terms of production and import, government and business officials said.According to the Ministry of Food and Drug Safety Friday, the production and import of 17 BTX drugs, including Botox, Botulax, Medytoxin, and
Celltrion has submitted an application to obtain approval for CT-P16, a biosimilar of Roche's Avastin (ingredient: bevacizumab), for colorectal cancer treatment in the U.S. and Korea.The company completed global clinical trials of CT-P16 at 150 cites in 20 countries in Europe, South America, and Asi
The government said Friday it would secure sufficient healthcare capacity first to move to the “live-with-covid” system from November.It was the first time that the government officially set its timeline to shift to the relaxed quarantine system, in which most restrictions are eased with officials f
Global pharmaceutical companies’ investment in R&D in Korea has continued to rise for the fifth consecutive year in 2020, an industry group report showed.The number of early clinical trials and studies of cancer and rare diseases increased significantly, and employment for R&D also expanded steadily
Merck’s oral antiviral treatment for Covid-19, molnupiravir, has reportedly shown potential efficacy on the variants of the Covid-19 virus, causing Korean companies to speed up efforts to develop similar oral medicines.Merck, or MSD in the U.S. and Canada, said Wednesday its experimental Covid-19 th
Takeda Korea said its ovarian cancer treatment Zejula would receive expanded health insurance coverage as maintenance therapy for breast cancer (BRCA) susceptibility gene-mutated ovarian cancer patients who responded to first-line platinum-based therapy from Friday.Under the latest revision, the gov
Korea Research Institute of Chemical Technology (KRICT) said Thursday that an HIV treatment candidate developed by its team has been transferred to a domestic company and began sales in China as a new drug.The institute said that the drug candidate, once could have been thrown away, was transferred
Vuno said that it has signed a contract to install VUNO Med-Chest X-ray, an artificial intelligence (AI)-based chest X-ray image reading solution, on Samsung Electronics' premium ceiling-mounted digital X-ray imaging equipment GC85A.The contract follows a deal in June to supply Vuno Med Chest X-ray
The Rehabilitation Engineering Research Center (RERC), affiliated with the Korea Workers’ Compensation & Welfare Service, said it would participate in a civil-military partnership program to help people with gait disorders walk more easily.The RERC has been selected as the lead research institute to
Bukwang Pharmaceutical said it would withdraw its plan to develop its antiviral drug Levovir (clevudine) as a Covid-19 treatment.The company said it had no intention to work on the drug again.Industry watchers said Bukwang’s failure to achieve the primary endpoint in a recent trial made it almost im
The government said Thursday that it would provide various support for companies to develop at least one homegrown mRNA Covid-19 vaccine by 2023.Next year, it will spend 526.5 billion won ($444 million) to help drugmakers conduct clinical and non-clinical studies while pre-purchasing homegrown Covid
GenBody said Thursday that the U.S. Food and Drug Administration granted emergency use authorization (EUA) for its GenBody COVID-19 antigen (Ag), a rapid diagnostic kit for Covid-19 in a nasal sampling format on Sep. 24.GenBody COVID-19 Ag provides diagnosis results within 15 minutes and can prevent
EOFlow has made the first shipment of the world's second wearable insulin pump, EOPatch, to the European market.EOPatch is a new-generation wearable insulin pump that succeeded in commercialization, solving the problem of long infusion lines in existing pumps, which had limited free movement for use
JW Pharmaceutical has begun marketing Livalozet, the first domestic combination drug of pitavastatin and ezetimibe, for treating dyslipidemia.The company said its dyslipidemia therapy doses are available in 2 or 4 milligrams of pitavastatin with 10 mg of ezetimibe. Medical professionals and patients