- Company
- 11 of the national essential drugs are non reimbursed
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- It was found that 11 of the drugs designated by The National Essential Medicine, excluding vaccines, are still non-reimbursed. As of December 31, 2021, 511 species have been designated as the National Essential Medicine, and 158 types of infectious disease-related drugs excluding vaccines. Of these, 11 drugs were not on the insurance benef
- Company
- TNBC will be added to Keytruda's indications
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- TNBC indications of the immuno-cancer drug Keytruda are expected to be added. According to related industries, the MFDS is currently conducting a last-minute review for further approval of the combination of chemotherapy in the first round of Triple-Negative Breast Cancer (TNBC) by PD-1 inhibitor Keytruda. Permission is expected within the th
- Policy
- Hanmi obtains generic exclusivity for Dapalon Duo
- by Lee, Hye-Kyung Jun 20, 2022 06:03am
- Hanmi Pharmaceutical obtained generic exclusivity rights for its SGLT-2 antidiabetic combination drug ‘Dapalon Duo SR Tab (Dapagliflozin Bis L-proline/ Metformin Hydrochloride),’ a generic version of ‘Xiguo XR Tab (Dapagliflozin Propanediol Hydrate/ Metformin Hydrochloride). The Ministry of Food and Safety recently granted marketing a
- Company
- Hee-Mok Won to “strengthen ties with Korean talents in US"
- by Kim, Jin-Gu Jun 20, 2022 06:03am
- The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) announced on the 16th that it will establish a communication and cooperation network with Korean talents that serve key roles in regulatory agencies, pharmaceutical companies, and venture capital (VCs) in the US to support the domestic companies’ entrance into the US
- Policy
- BA-linked listed drugs are about to be re-evaluated
- by Lee, Tak-Sun Jun 20, 2022 06:03am
- Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance. The MOHW announced that it would directly con
- Company
- Myungin challenges generic for exclusivity of Brintellix
- by Jun 20, 2022 06:03am
- Domestic pharmaceutical companies have launched an antidepressant Brintellix first generic challenge. According to the pharmaceutical industry on the 16th, Myungin and Unimed filed an application with the MFDS this month to approve generics of Lundbeck Korea Brintellix. It has been five months since the two companies filed a trial to confi
- Company
- The α-GPC's sentence of lawsuit has been postponed again
- by Chon, Seung-Hyun Jun 20, 2022 06:03am
- The sentence of the "cancellation of benefit reduction" lawsuit of the brain function improvement drug Choline Alfoscerate has been postponed again. According to the industry on the 16th, the 6th part of the Seoul Administrative Court changed the date of the lawsuit for cancellation of the notification of the application of health insuranc
- Company
- FDA grants ODD to LG Chem’s oral genetic obesity drug
- by Chon, Seung-Hyun Jun 20, 2022 06:03am
- LG Chem announced on the 16th that the US Food and Drug Administration has been additionally granted orphan drug status to its new genetic obesity drug ‘LB54640.’ The FDA has recently designated LB54640 as an orphan drug for the treatment of pro-opiomelanocortin (POMC) deficiency.’ The FDA has been operating an Orphan Drug Designat
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 20, 2022 06:02am
- The MFDS (Director Oh Yoo-kyung) announced on the 15th that it will change the efficacy, and indication precautions of "JAK Inhibitor", which is used as a treatment for inflammatory diseases. Patients can be used the same as before, but high-risk patients such as those aged 65 or older, high-risk cardiovascular groups, and risk of malignancy
- Policy
- The KDCA is pushing for the introduction of Tecovirimat
- by Lee, Jeong-Hwan Jun 20, 2022 06:02am
- The KDCA announced on the 14th that it will hold a joint meeting of related ministries to introduce 500 people of the antiviral drug Tecovirimat in July to respond to monkeypox. Kwon Joon-wook, head of the National Institute of Health, made this announcement at a briefing on COVID-19. The KDCA plans to hold a meeting of the monkeypox task
