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2025-10-24 02:24
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Opinion
[Reporter's View] Empty marketing of innovative new drugs
by
Son, Hyung Min
Feb 18, 2025 05:53am
As new drugs, such as antibody-drug conjugate (ADC), radiopharmaceutical, gene therapy, obesity drugs, and medications for Alzheimer's disease, have been introduced in various refractory disease areas, follow-on drug research & development (R&D) are gaining popularity. Companies involved in this movement highlight the significance of new d
Policy
Lorviqua, Tevimbra, Pemazyre enter NHIS negotiations
by
Lee, Tak-Sun
Feb 18, 2025 05:53am
Three items, including Lorviqua (lorlatinib, Pfizer Korea), Tevimbra Inj 100 mg (tislelizumab, BeiGene Korea), and Pemazyre (pemigatinib, Handok), are currently under negotiations with the National Health Insurance Service. These drugs were deliberated by the Health Insurance Review and Assessment Service Drug Reimbursement Evaluation Co
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
Policy
Daewoong¡¯s P-CAB Fexuclue completes first PVA
by
Lee, Tak-Sun
Feb 17, 2025 05:53am
Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, ¡®Fexuclue,' has agreed to complete negotiations through the price-volume agreement system with the National Health Insurance Service for the first time since its reimbursement listing. Before negotiations, Daewoong Pharmaceutical was known to have wanted to apply the
Company
COVID-19 vaccination and corporate productivity
by
Whang, byung-woo
Feb 17, 2025 05:53am
A study has been published showing that although the COVID-19 pandemic has transitioned into the post-COVID-19 era, there is a significant difference in productivity loss depending on whether or not one has been vaccinated. Analysis showed that the productivity loss caused by not receiving COVID-19 vaccination amounts to about KRW 5.6 trillio
Company
Vyloy with CDx issue resolved will launch in March
by
Whang, byung-woo
Feb 17, 2025 05:52am
The gastric cancer treatment Vyloy (zolbetuximab), which overcame the issue of companion diagnostics, will soon challenge the market. Reimbursement coverage with the National Health Insurance remains to be solved, but it has already received favorable assessments in the clinical practices. Despite launching as a non-reimbursed drug, it is lik
Company
Columvi can be prescribed at Big 5 hospitals in KOR
by
Eo, Yun-Ho
Feb 17, 2025 05:52am
¡®Columvi,' the first bispecific antibody treatment option for lymphoma, may be prescribed at general hospitals in Korea. According to industry sources, Roche Korea's CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) has passed the drug committees (DCs) of the Big 5 general hospitals in Korea, inc
Company
Expanded indication sought for Novartis 'Kisqali' in KOR
by
Eo, Yun-Ho
Feb 14, 2025 05:58am
Early breast cancer indication of a CDK4/6 inhibitor 'Kisqali' is expected to be introduced in South Korea. According to industry sources, Novartis has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) for Kisqali (ribociclib)'s expanded indication to treat early breast cancer. It is currently being reviewed
Policy
Vivozon¡¯s VVZ-2471 patent registered in China
by
Lee, Jeong-Hwan
Feb 14, 2025 05:58am
On the 23rd, Vivozon (CEO: Doo-hyun Lee), a company specializing in the development of innovative new drugs, announced that it completed registering the product patent for its oral non-narcotic analgesic VVZ-2471, which is being developed as a treatment for pain and addiction, and its derivatives in China. This is the company¡¯s third pa
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