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2025-05-01 15:21
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Jeil¡¯s super-antibiotic cefiderocol approved in Korea
by
Nho, Byung Chul
Feb 20, 2025 05:59am
Jeil Pharmaceutical (CEO Seok-je Sung) announced on the 19th that it has received approval from the Ministry of Food and Drug Safety to market the drug Fetroja Inj 1g¡¯ (cefiderocol sulfate tosylate) for the treatment of multidrug-resistant gram-negative bacterial infections. With the approval, adult patients may use Fetroja for the trea
Company
Myelofibrosis drug 'Omjjara' attempts at reimb listing
by
Eo, Yun-Ho
Feb 20, 2025 05:59am
'Omjjara,' a targeted treatment for myelofibrosis, attempts to be added to the National Health Insurance reimbursement list. According to industry sources, GSK Korea submitted a reimbursement application for its new myelofibrosis drug, Omjjara (momelotinib), at the end of last year, and is awaiting to be considered for the Health Insuranc
Company
Organon Korea releases first product after spinoff
by
Whang, byung-woo
Feb 20, 2025 05:58am
Organon Korea is launching a new product for the first time since its spin-off in June 2019 and is beginning to expand its influence in earnest. The product, which was unveiled about 3 years after the official launch of the Korean subsidiary, is JADA, a medical device used to control and treat postpartum hemorrhage. The company plans to targe
Company
Celltrion¡¯s Prolia and Xgeva biosimilars approved in Europe
by
Chon, Seung-Hyun
Feb 19, 2025 05:56am
On the 18th, Celltrion announced that it had received marketing authorization from the European Commission for Stobocolo and Osenvelt, which are biosimilar versions of Prolia and Xgeva, respectively. The final approval was granted 2 months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA
Company
Osteonoic secures rights to J&J¡¯s bone graft material
by
Lee, Seok-Jun
Feb 19, 2025 05:56am
Osteonic, a company specializing in implants for orthopedic surgery, announced on the 17th that it has secured the domestic rights to DBX Putty, a bone graft material, from Johnson & Johnson Medtech Korea. DBX Putty was developed by MTF Biologics Inc., a US bone graft manufacturer. Johnson & Johnson MedTech holds the global rights to the
Company
Next reimb effort for 'Padcev combination therapy'
by
Moon, sung-ho
Feb 19, 2025 05:56am
'Padcev Combination therapy' has been reported to have changed the urothelial cancer treatment paradigm after 30 years. After its launch in clinical practices in South Korea in the second half of last year, the government has initiated discussion for reimbursement of the therapy. According to the pharmaceutical industry on February 17,
Company
Will Tevimbra become the 1st reimbursed immunooncology drug?
by
Eo, Yun-Ho
Feb 19, 2025 05:56am
Will the first immuno-oncology treatment option in the field of esophageal cancer finally be born in Korea? BeiGene Korea's immuno-oncology drug Tevimbra (tiselizumab), which passed the Health Insurance Review and Assessment Service¡¯s Drug Reimbursement Evaluation Committee review last month, has entered into drug price negotiations with
Company
Opdivo prolongs survival in urothelial carcinoma
by
Whang, byung-woo
Feb 18, 2025 05:53am
The emergence of new drugs such as immuno-oncology drugs in the first-line treatment of urothelial carcinoma, have refined treatment strategies in the area. With the number of options available in the clinical setting increasing, there is also growing concern over when and which treatment to select for the patients. However, experts believ
Company
Samsung Bioepis¡¯s Prolia and Xgeva biosimilars approved
by
Chon, Seung-Hyun
Feb 18, 2025 05:53am
Samsung Bioepis' two bone disease treatment biosimilars have passed the US and European hurdles. Samsung Bioepis announced on the 16th that it has obtained marketing authorizations for its two biosimilar versions of Prolia and Xgeva, which are bone disease treatments, from the US Food and Drug Administration (FDA) and the European Commi
Company
Celltrion gains EU approval for Eylea biosimilar Eyedenzelt
by
Chon, Seung-Hyun
Feb 17, 2025 05:53am
On February 14, Celltrion announced that it had secured the marketing authorization for the Eylea biosimilar Eyedenzelt from the European Commission. Two months after receiving the recommendation for marketing authorization from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) in December, the drug was
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