- Company
- Celltrion receives CHMP positive opinion for 4 biosimilars
- by Chon, Seung-Hyun Dec 17, 2024 05:51am
- Celltrion announced on the 16th that the. European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorizations for its 4 biosimilar candidates. With the recommendations, Celltrion’s 4 biosimilar versions for Actemra, Eylea, Prolia, and Xgeva are expected to be approved in Europe. The bio
- Company
- Keytruda and Vyloy to transform gastric cancer treatment
- by Moon, sung-ho Dec 17, 2024 05:51am
- Metastatic gastric cancer has long been labeled as a drug-barren area on site. Various clinical studies have been conducted to develop new therapies for the area, but most have been unsuccessful. This is due to the tumor's heterogeneity, which makes it difficult to prove the efficacy of treatments. However, the recent introduction of immuno-o
- Policy
- Reimb of PE exemption drugs can be ex officio rejected
- by Lee, Tak-Sun Dec 16, 2024 05:53am
- In the future, drugs that sign refund-type risk-sharing agreements will be reviewed briefly by the Health Insurance Review and Assessment Service, focusing on changes, when a drug is reimbursed through the signing of the risk-sharing agreement more than 3 times. In addition, if a drug applies as a drug that can skip submission of pharma
- Company
- Soaring exchange rate causes pharma asset value to fluctuate
- by Kim, Jin-Gu Dec 16, 2024 05:53am
- The sharp rise in the won-dollar exchange rate in the aftermath of the impeachment and martial law has had a significant impact on the asset value of pharmaceutical and biotech companies. Companies with much foreign currency assets held in dollars have shown a significant increase in their asset value due to the high exchange rate, such as Sa
- Policy
- NHIS to expand the special estimate case system in 2025
- by Lee, Tak-Sun Dec 16, 2024 05:52am
- The National Health Insurance Service (NHIS) (Chairman: Jung Ki Suck) has announced plans to expand the reimbursement criteria for special cases of new rare diseases, starting on January 1, 2025. The NHIS aims to enhance essential medical support for individuals who currently do not benefit from receiving healthcare, including patients with r
- Company
- Daiichi Sankyo appoints Sunjin Lee to head Enhertu BU
- by Eo, Yun-Ho Dec 16, 2024 05:52am
- Daiichi Sankyo Korea has appointed Sunjin Lee (47), a former executive director of Takeda Pharmaceuticals Korea, as the new head of Daiichi Sankyo. According to industry sources, Daiichi Sankyo recently made the appointment. Lee will succeed Mr. Hyun-Joo Lee (48), who has left to head ZP Therapeutics Korea. After working at Baxter Kor
- Policy
- HLB Pharma applies for reimb of 'Citrelin ODT' for SCD
- by Lee, Tak-Sun Dec 16, 2024 05:52am
- HLB Pharma has reportedly applied to the Health Insurance Review and Assessment Service (HIRA) for reimbursement of 'Citrelin ODT,' a domestically distributed treatment for spinocerebellar degeneration. This product was approved in South Korea in 2015, but it has been distributed to the Korean market as a non-reimbursed drug. However, wit
- Policy
- Otezla generics enter negotiations for reimb
- by Lee, Tak-Sun Dec 13, 2024 05:52am
- Generic to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, is being considered for reimbursement negotiations with the National Health Insurance Service (NHIS). Attention has been drawn to whether a generic drug will be listed for reimbursement, the process in which a company with the original drug gav
- Company
- New PAH drug Winrevair to land in KOR next year
- by Eo, Yun-Ho Dec 13, 2024 05:52am
- The new pulmonary arterial hypertension drug ‘Winrevair’ is expected to be commercialized in Korea soon. According to industry sources, MSD Korea's Winrevair (sotatercept), the world's first symptomatic treatment for pulmonary arterial hypertension, recently passed the second approval-reimbursement linkage evaluations. The drug’s forma
- Opinion
- [Reporter's view] What corporates expect from entering pharm
- by Dec 13, 2024 05:52am
- Denmark's Novo Nordisk, the maker of the obesity drug 'Wegovy,' became Europe's No.1 in market capitalization in September last year. It topped France's luxury goods group LVMH Mo&235;t Hennessy Louis Vuitton SE (LVMH). At that time, Novo Nordisk's market cap was approximately KRW 790 trillion, exceeding Denmark's gross domestic product (GDP
