- Policy
- Novavax’s COVID-19 vaccine receives EUA in KOR
- by Lee, Hye-Kyung Dec 1, 2023 05:35am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced that it had granted emergency use authorization (EUA) for Novavax’s ‘Novavax COVID-19 Vaccine 2023-2024’ to respond to the Omicron subvariant (XBB.1.5). The Minister of Food and Drug Safety grants emergency use authorization when the head of relevant central adminis
- Company
- AstraZeneca appoints Sewhan Chon as new Country President
- by Eo, Yun-Ho Dec 1, 2023 05:35am
- Sewhan Chon (49), former Country President of AstraZeneca Indonesia, has been appointed the new Country President of AstraZeneca Korea. According to industry sources, Sewhan Chon has officially taken office as the Country President of AstraZeneca Korea as of the 1st. With the appointment, the former Country President, Kim Sang-pyo (53),
- Policy
- Imfinzi's 3-drug combo burden reduced despite nonreimb
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- An unprecedented decision was made at the Cancer Disease Review Committee meeting that was held on the 22nd. At the meeting, AstraZeneca failed to establish reimbursement standards for its Imfinzi Inj (durvalumab) as part of a three-drug combination therapy for biliary tract cancer, but the CDDC decided to grant reimbursement for the ge
- Company
- Demand for ADC Enhertu rise despite nonreimbursement
- by Kim, Jin-Gu Nov 30, 2023 05:55am
- Cumulative sales of Daiichi Sankyo’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab-deruxtecan)’ have exceeded KRW 10 billion even without reimbursement. According to the market research institution IQVIA on the 27th, Enhertu's cumulative sales were KRW 13.8 billion by Q3 this year. Sales steadily increased from KRW 2.2 bi
- Policy
- External ref price reevals will be carried out as planned
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- The Health Insurance Review and Assessment Service decided to thoroughly discuss its external reference price reevaluation plan with the industry. Although the government’s original plan of preparing a final draft by December is also expected to be postponed somewhat due to the prolonged discussions, HIRA explained that there is no change t
- Policy
- BeiGene applies for reimb of its 2nd new drug after Brukinsa
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Chinese new drug developer BeiGene is working to quickly receive reimbursement for its 2nd new drug, Tevimbra (tislelizumab) following its first new drug, Brukinsa (zanubrutinib). According to industry sources, the company had immediately applied for reimbursement listing of its Tevimbra upon its approval on the 20th. Tevimbra is a
- Company
- Samsung Biologics’ CMO orders exceed KRW 3 trillion this yr
- by Chon, Seung-Hyun Nov 29, 2023 05:50am
- Samsung Biologics announced on the 28th that its contract manufacturing organization (CMO) orders this year will exceed KRW 3 trillion. On the day, the company publicly announced that it signed 1 new and 4 expanded CMO deals. Samsung Biologics signed a CMO deal worth KRW 588.8 billion with Asian pharmaceutical companies. In addition,
- Policy
- HIRA starts preparing for RWE-based reimb reevaluations
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Health Insurance Review and Assessment Service are accelerating the establishment of a plan to reevaluate Korea’s reimbursed drugs based on RWD (Real World Data)/RWE (Real World Evidence). The idea of RWD/RWE-based reimbursement reevaluations took shape at the public hearing for the ‘Performance-based reimbursement management plan
- Policy
- DPM Choo ‘will finalize telemedicine plans this year'
- by Kang, Shin-Kook Nov 28, 2023 05:42am
- The direction of the government's policy to institutionalize non-face-to-face treatment has been set to institutionalize non-face-to-face treatment for overseas Korean nationals and prepare an improvement plan for the domestic non-face-to-face treatment pilot project within the year. Deputy Prime Minister Kyung-Ho Choo presided over the Emerg
- Company
- Korean companies bid to break AZ’s monopoly with FcRN drug
- by Son, Hyung-Min Nov 28, 2023 05:42am
- With new FcRn antibody drugs secured by Korean pharmaceutical companies demonstrating efficacy in myasthenia gravis, these new FcRn antibody drugs are expected to rise as a competitor to C5 complement inhibitors such as AstraZeneca’s Ultromiris and Soliris that currently occupy the market in Korea.
