- Policy
- Phase 3 of Voclosporin has been approved in Korea
- by Lee, Hye-Kyung Apr 7, 2022 06:10am
- Phase 3 clinical trials of Voclosporin, the first oral treatment for lupus nephritis, will be conducted in Korea. On the 6th, the MFDS approved a clinical trial of Voclosporin, an LN treatment of Aurinia Pharmaceuticals, a subsidiary of Iljin SNT. Phase 3 clinical trials will be conducted at Seoul National University Hospital and Kyungp
- Policy
- The negotiation period for patent expired drugs ,shortened
- by Lee, Jeong-Hwan Apr 7, 2022 06:10am
- The Regulatory Reform Committee passed a regulation that would shorten the negotiation period for lowering the drug price of the original patented drug from 60 days to 20 days, effectively confirming its implementation. According to the results of the drug price reduction dispute, the revision of the law, in which the government refunds damag
- Policy
- 76 generics for DM tx Jardiance Duo have been approved
- by Lee, Hye-Kyung Apr 6, 2022 06:06am
- Generics for Jardiance Duo, a diabetes treatment complex affiliated with SGLT-2 inhibition of Beringer Ingelheim, have been approved. On the 4th and 5th, the MFDS approved 76 items of Empagliflozin/Metformin HCl from 26 pharmaceutical companies. Generics for Jardiance Duo are commissioned by Dongkoo Bio. Empagliflozin/ Metformin for the
- Policy
- Oral COVID-19 drugs prescribed to 1 in 100 patients
- by Lee, Jeong-Hwan Apr 6, 2022 06:06am
- One out of every 100 confirmed COVID-19 patients were found to have been prescribed oral COVID-19 treatments (Paxlovid·Lagevrio). According to the data NA’s Health and Welfare Committee member Hyun-Young Shin of the Democratic Party of Korea received from the Korea Disease Control Prevention and Control Agency on the 5th, a total of 124,571
- Policy
- It will not be easy to reflect generic positive list system
- by Lee, Tak-Sun Apr 6, 2022 06:05am
- The NHIS has completed a study of external services that only provides a positive list of excellent generics, but it is not expected to be easy to reflect the policy. This is because the research was promoted by the current government and it is still unreasonable to lead to policies. On the 31st of last month, the NHIS registered a "resear
- Policy
- Kymriah has been listed, hope of cure
- by Lee, Jeong-Hwan Apr 5, 2022 05:57am
- Patients immediately welcomed the confirmation of health insurance benefits of the acute lymphocytic leukemia and lymphoma CAR-T treatment Kymriah (Tisagencleucel). The patients urged the transition committee of the next presidential post and Yoon Seok-yeol to quickly register new drugs directly related to life as health insurance benefits
- Policy
- Phase 3 of Jetema the toxin will be conducted in Korea
- by Lee, Hye-Kyung Apr 4, 2022 06:07am
- Jetema the toxin 100U, which has been approved for export botulinum toxin, will conduct phase 3 clinical trials in Korea. The MFDS recently approved Jetema the toxin for a "multi-organization, double-blind, random assignment, parallel design, noninferiority trials, active control groups, and phase 3 clinical trials" for JTM201. The clinica
- Policy
- 20 ultra-high-priced drugs over ₩5 mil sold in Korea
- by Lee, Tak-Sun Apr 4, 2022 06:07am
- Survey results have shown that 20 high-priced drugs over &8361;5 million are approved for reimbursement 10 years after, Soliris, which had been then the most expensive drug in the world, was listed for reimbursement in Korea With ‘Kymriah,’ the one-shot treatment that was listed for reimbursement on April 1st, recording the highest pri
- Policy
- Based on PVA exclusion, the arithmetic average is 90%
- by Lee, Tak-Sun Apr 4, 2022 06:07am
- Drugs subject to PVA with an arithmetic average of less than 90% of the same product group are excluded. Previously, only drugs below the arithmetic average were excluded, but the target was further narrowed to less than 90%. Products with annual claims of less than 2 billion won are also excluded from PVA drugs. Previously, products worth
- Policy
- To commercialize innovative new drugs/supply essential drugs
- by Lee, Jeong-Hwan Apr 3, 2022 04:25pm
- The MFDS reports discuss ways to become a bio-health powerhouse The Presidential Acquisition Committee Yoon Seok-yeol and the MFDS agreed to systematically support the commercialization of high-tech and innovative medical products and establish a stable supply environment for rare essential drugs with low profitability. The transition com
