- Policy
- The reasons why Hemlibra's benefit was not recognized?
- by Lee, Hye-Kyung Jul 3, 2021 05:56am
- The HIRA's Central Review and Coordination Committee revealed specific reasons for not recognising benefit of JW Pharma's Hemlibra (Emicizumab). The HIRA released a June review of the Review and Assessment Committee on its portal on Thursday. There are five cases of deliberation, including Hemlibra, Soliris, ventricular assistive therapy,
- Company
- Opdivo+Yervoy's negotiations failed to reach an agreement
- by Jul 1, 2021 05:56am
- Drugs for the combination of the immuno-cancer drugs Opidivo (Nivolumab) and Yervoy (Ipilimumab) in primary treatment for kidney cancer were not negotiated within days. In the end, it is expected to take longer to apply the benefit. According to related industries on the 1st, Ono Pharmaceutical and BMS have extended drug price negotiations
- Company
- Yuhan’s Leclaza reimb. held back by companion diagnostics
- by Eo, Yun-Ho Jul 1, 2021 05:56am
- Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed. The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary
- Policy
- Rationalizing ICER threshold requires various considerations
- by Kim, Jung-Ju Jul 1, 2021 05:56am
- Insurance authorities expect the evaluation results of the listed drugs that underwent quality reassessment on the reasonableness of their medical care benefit (re-evaluation of medical benefits of listed drugs) will be applied as early as October this year. This means that the results will pass the Health Insurance Policy Deliberative Comm
- Company
- Hanmi’s Efpeglenatide reduces cardiovascular risk
- by Chon, Seung-Hyun Jul 1, 2021 05:55am
- Sanofi announced a study that reduces the risk of cardiovascular and kidney disease of new diabetes drugs that have returned rights to Hanmi. Hanmi plans to find new opportunities based on research results. According to Hanmi on the 29th, Sanofi held an independent session for Efpeglenatide at the American Diabetes Association (ADA) and an
- Policy
- Targets for PVA in third quarter include Darzalex & Alunbrig
- by Lee, Hye-Kyung Jul 1, 2021 05:55am
- Janssen Korea's (Daratumumab) and Takeda Korea’s Alunbrig (Brigatinib) were included in the Price-Volume Agreement (PVA). Otsuka Pharmaceutical Korea's "Iclusig" and AstraZeneca Korea's "Impinji" (Dubalumab) were also subject to negotiations on drug prices due to increased usage. The NHIS recently introduced "PVA (Type Ka/Na) Monitorin
- Company
- Generics for Pradaxa, Xarelto & Brilinta will be released
- by Kim, Jin-Gu Jun 30, 2021 05:57am
- Material patents of Pradaxa and Xarelto expire in July and October this year, respectively. As a result, 8 generics for Pradaxa and 200 generic for Xarelto are expected to be released early in the second half of this year. In November, 25 generics for Brilinta will be released. Ahn-Gook's generic for Galvus is expected to be released within the
- Policy
- 2 indications deleted for choline alfoscerate, changes label
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Authorities have ordered companies to delete the No.2 and No.3 indication of the brain function enhancer choline alfoscerate, for which the clinical re-evaluations have started recently. Accordingly, the indication must be removed from the label from the 28th of next month. Also, the Ministry of Food and Drug Safety requested doctors and
- Opinion
- [Reporter’s view] Confusion by 1+3 bill must be minimized
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Sharing the results of the biological equivalence test with other companies and obtaining permission is restricted by the revision of the law. The National Assembly passed the pharmaceutical affairs law amendment on the 29th, which included 1+3 bill. Accordingly, a trustee who manufactures medical supplies may share permitted data and sup
- Company
- JW Pharma acquires domestic license for fostamatinib
- by Chon, Seung-Hyun Jun 30, 2021 05:56am
- On the 28th, JW Pharmaceutical Corporation announced that it has entered into a licensing agreement with Kissei Pharmaceutical Co., Ltd for the development and commercialization rights in Korea of fostamatinib, a thrombocytopenia treatment. Under the licensing agreement, JW Pharmaceutical may develop, obtain regulatory approval, and marke
