MedPacto, a Korean drug developer, said its cancer drug candidate vactosertib has obtained the European Medicines Agency’s (EMA) orphan medicinal product designation (OPD).The EMA’s OPD entitles the drug to a full or partial fee reduction in the authorization process, the company said. In 2021, vact
The legal battle between the Ministry of Food and Drug Safety (MFDS) and Medytox over the "indirect export" of the latter’s botulinum toxin (BTX) products has entered the second round.Indirect export refers to selling BTX products to domestic distributors without getting lot release approval from th
GI Innovation, a Korean drug developer, said on Thursday that it successfully registered a European patent for its allergy drug GI-301 (YH35324) and microbiome combination therapy.Accordingly, the patent not only has no sequence limitation for IgE TRAP, but also covers the microbiome, securing a bro
Yuhan Corp. is drawing the industry’s attention by sharply improving patient access to its new lung cancer drug Leclaza (lazertinib), through an expanded access program (EAP).According to medical sources, the first and second patients prescribed Leclaza free of charge through EAP have been registere
HLB, a Korean anticancer drug developer, has announced the publication of positive results from its global phase 3 trial of rivoceranib in combination with camrelizumab for patients with unresectable hepatocellular carcinoma (HCC) in The Lancet on Monday.The Lancet is the world’s highest-impact gene
MSD Korea said on Tuesday it has appointed Albert Kim, a former vice president of Samsung Bioepis, as the new managing director, effective August 1, 2023.The position has been vacant for six months after the previous managing director, Kevin Peters, left to serve as managing director at MSD Germany
GI Biome said on Tuesday that it signed a memorandum of understanding (MOU) with ProGen, a company with a multi-target antibody platform, to develop a next-generation obesity treatment. Accordingly, both companies plan to conduct joint research on the combination of Progen's obesity drug candidate a
Daewoong Pharmaceutical said on Tuesday that its U.S. partner AEON Biopharma was listed on the New York Stock Exchange (NYSE) on Monday, securing $125 million in investment capital for the therapeutic indications of Daewoong’s Nabota botulinum toxin (BTX).A day earlier, Daewoong said it paid 48.3 bi
Merck’s anti-PD-L1 immuno-oncology drug Bavencio (avelumab) will get insurance coverage starting next month as first-line maintenance therapy for adult patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed on platinum-based chemotherapy.Health Insurance R
Pfizer Korea recently obtained full approval for its Covid-19 oral antiviral treatment Paxlovid from the Ministry of Food and Drug Safety (MFDS), but concerns have been raised about vaccine damage compensation for its Covid-19 vaccine, Comirnaty.Along with this concern, Pfizer Korea held a press mee
Kwangdong Pharmaceutical said that it has partnered with Chiesi Farmaceutici, an Italy-based global pharmaceutical company, for the exclusive distribution of the latter's three rare disease drugs in Korea.Under the accord, Chiesi will supply Raxone, Elfabrio, and Lamzede.Raxone is an original drug i
Sillajen said Monday its clinical study on the combination of Pexa-Vec and Libtayo has been accepted as a poster at the European Society for Medical Oncology Annual Meeting 2023 (ESMO 2023) in Madrid in October.In 2017, Sillajen entered into a collaboration agreement with Regeneron for the clinical
Researchers from Yonsei Cancer Center discovered a three-drug combination -- comprising HER2-targeted therapy, trastuzumab, and ramucirumab plus paclitaxel, the existing standard of care -- which demonstrated superior efficacy and fewer side effects than other agents in patients with HER2-positive a
SK chemicals said Thursday that it signed a global contract manufacturing organization (CMO) agreement with AstraZeneca for the supply of Sidapvia. Sidapvia is a combination of Forxiga (ingredient: dapagliflozin) and sitagliptin, approved in Korea to treat type 2 diabetes in adults aged 18 years and
Targeted cancer therapies such as T cell bispecific antibodies, sometimes called bispecific T cell engagers, have been attracting more attention for their ability to hone in on the cancerous cells, and domestic companies are ready to get in on the action.Last year, the U.S. FDA approved Immunocore’s
Osang Healthcare (OHC), which recently signed a comprehensive business cooperation agreement with Yuhan Corp., has emerged as the second largest shareholder of one of the latter’s subsidiaries.Osang Healthcare said Thursday that the company has completed paying money for the three-party capital incr
The recent mislabeling of medicines by Hyundai Pharm and other incidents of drug mix-ups are threatening consumers’ health, consumer groups said.Issuing a statement Wednesday, the Citizens United for Consumer Sovereignty (CUCS), a consumer advocacy group, criticized Hyundai Pharm’s labeling errors,
Astellas Korea has officially launched Padcev (ingredient: enfortumab vedotin), which treats locally advanced or metastatic urothelial cancer.Padcev, an antibody-drug conjugate (ADC) that targets Nectin-4, received approval from the Ministry of Drug Safety as a monotherapy in March. It has a categor
Pfizer's first-in-class CDK4/6 inhibitor, Ibrance (palbociclib), has received an expanded indication in Korea.It can now be used as first-line endocrine therapy in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast
GC Biopharma said on Wednesday that its quadrivalent flu vaccine, GC FLU Quadrivalent inj., has been approved by the Egyptian Drug Authority (EDA), marking the company's first approval on the African continent. Egypt has one of the largest pharmaceutical markets in the African region, with the flu v