- Company
- FDA approves BLA for Dong-A ST’s Stelara biosimilar
- by Chon, Seung-Hyun Jan 11, 2024 05:45am
- Dong-A ST announced on the 5th that Accord Biopharma, a subsidiary of Intas Pharmaceuticals, has completed Biologics License Application (BLA) for Stelara biosimilar ‘DMB-3115’ to the U.S. Food and Drug Administration (FDA). The BLA, originally submitted in October 2023, has now been approved by the FDA. The BLA submission was based on
- Company
- Dong-A ST signs MOU with Israel’s Eleven Therapeutics
- by Son, Hyung-Min Jan 11, 2024 05:45am
- On the 9th, Dong-A ST announced that it had signed a memorandum of understanding (MOU) with Israel-based Eleven Therapeutics to develop an RNA-based gene therapy at the JP Morgan Healthcare Conference in San Francisco, USA. The two companies will conduct joint research to discover targeted RNA therapies for fibrotic diseases using Eleven
- Company
- 5th JAK inhibitor Jyseleca lands in general hospitals in KOR
- by Eo, Yun-Ho Jan 11, 2024 05:45am
- Another JAK inhibitor can now be prescribed at general hospitals in Korea. According to industry sources, Gilead's Jyseleca (filgotinib) has passed the drug committee (DC) review of major national hospitals and medical institutions like Seoul Asan Medical Center and Hanyang University Hospital. After the drug was approved for reimburse
- Opinion
- [Reporter's View] GOV takes measures to stabilize supply
- by Lee, Hye-Kyung Jan 11, 2024 05:45am
- To resolve the issue of medicines supply instability, the government has announced a plan to conduct a field investigation of pharmacies and hospitals that engage in stockpiling of drugs, in collaboration with a local government starting in January. This is the government’s first active involvement in checking nursing homes and taking adm
- Policy
- HIRA establishes new Pharmaceutical Benefits Dept
- by Lee, Tak-Sun Jan 11, 2024 05:44am
- High-priced drugs are changing the drug expenditure review paradigm in Korea. The high cost borne from the use of high-price drugs is increasing the importance of post-listing evaluation of high-priced drugs. To address this shift, the Health Insurance Review and Assessment Service established a ‘Pharmaceutical Performance Evaluation De
- Policy
- MFDS to resolve production of chemotherapy drug '5-FU'
- by Lee, Hye-Kyung Jan 10, 2024 05:42am
- One of the domestic pharmaceutical companies has agreed to produce the chemotherapy drug ‘5-fluorouracil (5-FU) injection.’ This measure will significantly aid in the treatment of cancer patients. ‘Since November last year, we received an information from the Korean Society of Health-system Pharmacists about a drug shortage of the ch
- Product
- Saxenda’s shortage prolonged…raises inconveniences
- by Kang, Hye-Kyung Jan 10, 2024 05:42am
- Saxenda's prolonged out-of-stock status is inconveniencing consumers as well as pharmacies. As many patients set New Year’s resolutions of losing weight at the beginning of the year, the lack of Saxenda is causing dissatisfaction among pharmacies and consumers. Even diabetes patients are experiencing the inconvenience of insulin stockout
- InterView
- Restoring confidence post-Invossa incident was my priority
- by Kim, Jin-Gu Jan 10, 2024 05:42am
- “Even in the face of failure, do not worry. As the CEO of the company, I will take full responsibility for everything. We will engage in frequent communication. Once we reach a consensus after thorough discussions, I will bear responsibility for the outcome, regardless of the outcome.” In his inaugural speech in March of the previous year,
- Opinion
- [Reporter’s View] Be generous and provide tangible benefits
- by Eo, Yun-Ho Jan 10, 2024 05:42am
- Expectations of pharmaceutical companies that own new drugs have been rising in the light of the new year. The reason for this is the ‘Plan for Appropriate Compensation of the Innovative Value of New Drugs' that the government announced at the end of last year. According to the announcement, the government will grant reimbursement for in
- Policy
- Will Enhertu be discussed in this year’s 1st DREC meeting?
- by Lee, Tak-Sun Jan 10, 2024 05:42am
- The schedule for the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meetings in 2024 has been finalized and released. The committee meeting will be held at the beginning of each month, starting with the first meeting on the 11th of this month. According to industry sources on the 8th, the 2024 DR
