- Policy
- Only 6 out of 9 reimbursed use of Spinraza approved
- by Lee, Hye-Kyung Jan 3, 2020 06:31am
- Only 66.6 percent of preliminary approval applications for reimbursement submitted last month was cleared for the use of spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). Six out of nine applications were approved, and other three applications were rejected with conditional approval, disapproval and required supplementary data.
- Policy
- Rare cancer reoccurred in patients with Allergan’s implants
- by Lee, Tak-Sun Jan 2, 2020 11:21pm
- Another patient with rare cancer developed after breast augmentation with Allergan’s coarse surface implants. This is the second time since it was first reported in Korea on August 14th. The Minister of Food and Drug Safety, Eui-Kyung Lee and the Korean Society of Plastic and Reconstructive Surgeon(Chairman, Kwang Seog Kim) announced on t
- Policy
- Reimbursed Dupixent requires prior prescription record
- by Kim, Jung-Ju Jan 2, 2020 11:20pm
- The reimbursement criteria for patients taking now listed Sanofi Aventis Korea’s severe atopic dermatitis treatment Dupixent Pre-filled syringe 300 mg (dupilumab) were officially disclosed. Reimbursement on the treatment is granted for an adult patient age over 18 with chronic and severe atopic dermatitis symptoms continuing over three
- Policy
- ₩2.8 billion will be invested in AI drug development
- by Kim, Jung-Ju Jan 2, 2020 06:09am
- The government will greatly strengthen investment in innovation growth in the biohealth sector, which is called the future food industry, such as the pharmaceutical industry and increased the budget by 13% to &8361;527 billion, and doubled the budget by building big data, new drug development platform, and support for the development of th
- Policy
- Lipiodol’s gap recurrence prevention law is pushed forward
- by Lee, Jeong-Hwan Jan 2, 2020 06:06am
- A bill, which the government is obliged to conduct regular surveys on the state of supply of essential medicines, to build a stable supply environment will be promoted. The legislative goal is to prevent the gap of essential medicines to prepare for major national disasters such as terrorism and radioactive pollution. Representative Myu
- Policy
- Report find MFDS cleared 112 IMDs in past decade
- by Lee, Tak-Sun Jan 2, 2020 06:05am
- Apparently, more than half of incrementally modified drugs (IMDs) approved in the past decade were combination drug. And majority of them were approved for treating chronic disease. On Dec. 30, Korea’s Ministry of Food and Safety (Minister Lee Eui-kyung) published ‘IMD Approval Report’ reviewing current status and past cases of approv
- Policy
- Keytruda-Lenvima already got 9 trials approved in Korea
- by Lee, Tak-Sun Dec 31, 2019 05:51am
- MSD Korea and Eisai Korea are conducting a series of clinical studies in Korea to confirm cancer-treating efficacy of combination therapy of immunotherapy Keytruda (pembrolizumab) and targeted therapy Lenvima (lenvatinib). In Korea alone, nine clinical protocols on the combination therapy have been approved. The pharmaceutical industry
- Policy
- Maviret, liver & kidney transplant patients benefit extended
- by Kim, Jung-Ju Dec 31, 2019 05:51am
- Liver and kidney transplant patients will be expanded and added to the administration of adult chronic hepatitis C treatment drug, Maviret (Glecaprevir + Pibrentasvir), and the reimbursed period of administration will be divided. reimbursed indication of Jext inj (Epinephrine bitartrate)150μg is changed to anaphylaxis, and covered up to
- Policy
- IMD pricing reduction dispute to continue on
- by Lee, Jeong-Hwan Dec 30, 2019 09:48pm
- Pharmaceutical industry and lawmakers are reprehending the government for not laying down any specific plan, despite their demand for the government to abolish or revise the pricing reduction policy on new incrementally modified drugs (IMDs). The criticism is on the lack of any follow-up action from the government, although Minister of
- Policy
- Impurity checks are left to the industry
- by Lee, Tak-Sun Dec 30, 2019 09:47pm
- As announced after the 2018 Valsartan incident, the MFDS focused on regulating generic entry this year. In the sense that all restrictions can be made, irrational systems were introduced as soon as possible to prevent the entry of generics. Generic regulatory measures, including restrictions on cooperative and entrusted activities, the i
