- Policy
- Chong Kun Dang's CKD-306 is approved for phase I
- by Lee, Tak-Sun Feb 3, 2020 06:20am
- Chong Kun Dang is continuing to develop a combination of diabetes drug 'Duvie' and DPP-4 inhibitor 'Sitagliptin'. In 2016, Chong Kun Dang, a candidate for the development of a combination drug known through clinical approval of drug interactions, was recently approved for phase I clinical trials and is now in full swing. The Ministry of
- Policy
- Industry welcomes pricing benefit unchanged for IMD
- by Lee, Jeong-Hwan Jan 31, 2020 06:35am
- The Korean pharmaceutical industry is positively reacting to Ministry of Health and Welfare’s (MOHW) revised drug pricing system including the weighted pricing benefit for incrementally modified drug (IMD) as it would allow IMDs to remain as a cash cow generating finance for new drug R&D. Although they are regretful the weighted pricing
- Policy
- Besivo's reimbursement standards expanded
- by Kim, Jung-Ju Jan 31, 2020 06:35am
- If the patient progresses to liver cancer during treatment with Besifovir oral medications, the benefit is still acceptable. In the case of Ramosetron HCl oral medications, there will be no restriction on the duration of administration, up to 12 weeks. The Ministry of Health and Welfare was confirmed on 28th after hearing opinions by th
- Policy
- Cresemba, Pfizer Korea's antifungal drug, approved
- by Lee, Tak-Sun Jan 30, 2020 06:34am
- Pfizer Korea obtained the product license of the antifungal drug Cresemba (Isavuconazole Sulfate) in Korea. The drug is expected to have a lower mortality rate than Pfizer's Vfend. The Ministry of Food and Drug Safety approved on the 29th the sale of 'Cresemba capsule 100mg' and 'Cresemba injection 200mg' of Pfizer Korea. Cresemba i
- Policy
- President Moon wearing a mask visited the NMC
- by Kim, Min-Gun Jan 30, 2020 06:33am
- Cheong Wa Dae announced at 10:31 am on the 28th that President Moon Jae-in visited the National Medical Center, which is treating a new type of coronavirus infection, and directly inspected the field response system and ordered a total response posture. Mr. Moon made this report at the spot where he received on-site response system repor
- Policy
- Amendment to cascading drug price revision revealed
- by Kim, Jung-Ju Jan 30, 2020 06:33am
- Finally came the result. The reinstatement of the cascading drug price system was revised and revised to change the generic insurance price according to whether or not it had its own bioequivalence test. As is known, there is a difference in the price of IMDs and generics. Revisions were included to keep the addition in recognition of the eff
- Policy
- Rafinlar-Meqsel combination done with pricing negotiation
- by Lee, Hye-Kyung Jan 30, 2020 06:33am
- A combination therapy of Rafinlar and Meqsel treating patients with ultra-rare late stage BRAF-mutant lung cancer would be available for reimbursed prescription from next month at earliest. Korea’s National Health Insurance Service (NHIS) has recently announced pricing negotiations on four items&8212;Novartis’ Rafinlar (dabrafenib) 5
- Policy
- Janssen prepares to close Hyangnam plant, renewing licenses
- by Lee, Tak-Sun Jan 29, 2020 06:27am
- Janssen Korea is to close Hyangnam plant in 2021 and the company is speeding up the process of transferring items manufactured in Hyangnam to other facilities. Apparently some of them would be transferred to other Korean manufacturing companies, whereas some would be manufactured abroad and imported to Korea. As of Jan. 28, Korea’s
- Policy
- Korea-Switzerland promulgated an AMR on GMP
- by Lee, Jeong-Hwan Jan 29, 2020 06:26am
- The AMR (Agreement on Mutual Reliance) on GMP (Good Manufacturing Practice) between Korea and Switzerland was promulgated on the 23rd. It is a follow-up after the MFDS (Ministry of Food and Drug Safety) signed a GMP agreement with the SWISSMEDIC (Swiss Drug Agency) on December 18 last year. The agreement promulgated the mutual recognitio
- Policy
- Hanmi’s salt-modifying drug for Galvus was approved
- by Lee, Tak-Sun Jan 29, 2020 06:25am
- A salt alteration drug of Galvus(Vildagliptin) by Hanmi, a DPP-4 inhibitor for diabetes was approved. But one indication in the original drug is excluded. It is understood as a strategy to avoid patent The Ministry of Food and Drug Safety approved the generic product (50mg) for Galvus by Hanmi. Unlike the original galvus, this generic has
