- Policy
- Ticagrelor Napadisylate by Chong Kun Dang was applied
- by Lee, Tak-Sun Jul 7, 2020 06:13am
- It has been shown that Chong Kun Dang developed a salted product of Ticagreler (Brilinta, AstraZeneca) and applied for permission to the MFDS. It is the first product to be approved as a Ticagrelor salt product. Anti-thrombotic agent, Ticagrelor, is a poorly soluble drug and is known to have poor solubility, so it has been noted whether sa
- Policy
- Daewoong's Camostat was approved for clinical trial phase II
- by Lee, Tak-Sun Jul 7, 2020 06:12am
- Daewoong has been approved for clinical trials in patients with mild and moderate COVID-19 as a drug with Camostat Mesilate used as a treatment for pancreatitis. The MFDS approved a plan for phase II clinical trial for 'DWJ1248', which Daewoong applied for on the 6th. DWJ1248 is known as Camostat Mesilate. Daewoong holds Foistar (Camost
- Policy
- Stepped drug pricing applied on maximum price as of Aug 1
- by Kim, Jung-Ju Jul 7, 2020 06:12am
- The Korean government unveiled the specified schedule and plan to apply stepped drug pricing system, also known as the upper limit price reevaluation on listed drug. Although the Regulatory Reform Committee ordered Ministry of Food and Drug Safety (MFDS) to drop the ‘1+3 joint bioequivalence test system’ from the revised ‘Regulation o
- Policy
- Samsung Bioepis' Adalloce prefilled pen was approved
- by Lee, Tak-Sun Jul 6, 2020 06:15am
- Samsung Bioepis’ pen type product of Humira (Adalimumab) biosimilar named Adalloce has additionally approved in Korea It is evaluated as a product with improved convenience of administration than Adalloce PFS that was approved in September 2017. The MFDS approved Samsung Bioepis' Adalloce prefilled pen 40mg on the 3rd. This product is
- Policy
- Pariet holder was changed from Janssen to Kolmar in 20 years
- by Lee, Tak-Sun Jul 6, 2020 06:15am
- The domestic license holder for 'Pariet', a PPI used for GERD, has been changed in 20 years. As Janssen Korea operates the Hyangnam factory until next year, the manufacturer has finally changed. Eisai Korea is in charge of sales. According to related industries on the 3rd, the permit holders of Pariet licensed in 2000 were changed fr
- Policy
- Korean government designates remdesivir essential drug
- by Lee, Tak-Sun Jul 6, 2020 06:14am
- The Korean government has designated specially imported COVID-19 treatment remdesivir, and clinically used COVID-19 treatment Kaletra (lopinavir/ritonavir) as National Essential Drugs. National Essential Drugs are designated to be constantly monitored for stock and supply flow, and to receive support for special importation clearance or
- Policy
- 33 seriously ill patients are eligible for free Remdesivir
- by Kim, Jung-Ju Jul 3, 2020 06:18am
- Gilead Science Korea's COVID-19 treatment 'Remdesivir' was supplied to Korea on the 1st of today. A total of 33 seriously ill candidates will be eligible for the first free application. However, they request to be administered at the discretion of the attending physician, and whether or not to administer is determined according to the sel
- Policy
- It started supplying Remdesivir to Korea for free for July
- by Lee, Tak-Sun Jul 3, 2020 06:17am
- Gilead's 'Remdesivir', a COVID-19 treatment, is supplied to Korea. In the month of July, the supply will be used free of charge. It is planned to be purchased and used through price negotiations after August. The director of The KCDC (Jung Eun-Kyeong) announced that it will supply Remdesivir, which was specially imported as a treatment for
- Policy
- Lipiodol takes government’s pricing reduction to the court
- by Kim, Jung-Ju Jul 3, 2020 06:17am
- The government’s price reduction on Lipiodol Ultra Solution (iodized oil), supposed to be effective from July 1 with the release of generic, is now heading to the courts as the company objected to the decision. Until the judgment is made, the court has allowed Guerbet Korea to sell the drug for the original reimbursed price temporarily
- Policy
- Amgen's Eylea biosimilar has been approved for Phase III
- by Lee, Tak-Sun Jul 2, 2020 06:10am
- Amgen is conducting a phase III clinical trial on Eylea biosimilar in Korea. Recently, Samsung Bioepis' Eylea biosimilar has also been approved for phase III clinical trials in Korea, so the Korean market is expected to face strong competition between Big Pharma and native biosimilar companies. On the 29th of last month, the MFDS app
