- Policy
- Celltrion's CT-P59 was approved for phase I clinical trial
- by Lee, Tak-Sun Jul 21, 2020 06:10am
- Celltrion's development of COVID-19 antiviral antibody treatment has been approved for clinical trials in Korea. The MFDS announced that it has approved a phase I clinical trial on the 17th for 'CT-P59', a domestically developed COVID-19 antiviral antibody treatment. As a result, a total of 13 clinical trials (11 treatments, 2 vaccines) w
- Policy
- Generic exclusivity is on the verge of change
- by Lee, Tak-Sun Jul 20, 2020 06:19am
- The system of generic exclusivity, which grants the monopoly of the market for 9 months to patented generic drugs, is on the verge of change. It is expected that the measures to improve the right to generic exclusivity that were promoted through the public-private council will soon reveal its outline. As the process of the meeting is delay
- Policy
- Integrating PMS with RMP to protect new drug information
- by Lee, Tak-Sun Jul 20, 2020 06:19am
- The post-marketing surveillance (PMS) system that monitors new drug’s adverse reaction experienced by patients to maintain the drug safety would be integrated with the risk management plan (RMP) review system. The number of investigated subjects would be reasonably adjusted and the data protection system for the authorized new drug woul
- Policy
- Minister Park is trying to preliminarily secure Remdesivir
- by Lee, Jeong-Hwan Jul 20, 2020 06:19am
- Minister Park Neung-Hoo, from the MOHW said he is trying to maximize the estimated number of seriously ill patients in Korea to preliminarily secure the Remdesivir, known as a cure for COVID-19. One of the criteria for the distribution of Remdesivir around the world is the number of seriously ill patients, so it aims to do its best to ensu
- Policy
- Generic pricing negotiation from Sept to protect patients
- by Lee, Hye-Kyung Jul 17, 2020 05:55am
- Korea’s National Health Insurance Service (NHIS) plans to negotiate pricing on generics from September. On July 15, NHIS submitted briefing material for the National Assembly provisional session that elaborated the outcomes of the healthcare coverage enhancement (Moon Jae-in Care) and the government’s prospective plan to lower medical
- Policy
- Domestic vaccine development for COVID-19 aims at 2021
- by Lee, Jeong-Hwan Jul 17, 2020 05:55am
- It is expected that the government will start a clinical trial of COVID-19 blood plasma therapy in early September and will be able to secure treatments throughout the year. Antibody therapies, except for blood plasma therapies, are scheduled to go through clinical trials, and the government expects that antibody therapies will be secured
- Policy
- The MFDS will enact a law covering special cases
- by Lee, Tak-Sun Jul 16, 2020 05:54am
- The MFDS decided to promote the establishment of a law covering special cases to support the approval of vaccines and treatments for new infectious diseases such as COVID-19. It also plans to establish the Central IRB to expedite clinical trials. The MFDS made the announcement through the 'Major Business Reports' submitted to the National
- Policy
- Use patent of Xarelto 2.5mg listed late
- by Lee, Tak-Sun Jul 15, 2020 07:54am
- Although Hanmi and SK Chemicals acquired market monopoly rights as a follow-up drug to the anticoagulant drug (NOAC), Xarelto 2.5mg (Rivaroxaban), it may not exercise its right. This is because the use patent for Xarelto 2.5mg has been listed in the MFDS after the acquisition of the rights of both companies. According to the MFDS, H
- Policy
- Emergency use of KRW 5.13 mln Soliris covered for aHUS
- by Lee, Hye-Kyung Jul 15, 2020 06:32am
- Soliris (eculizumab) injection costing 5.13 million won per vial is to get coverage for an emergency administration. Korea’s Health Insurance Review and Assessment Service (HIRA) has recently made an additional checkbox on the preliminary approval application for Soliris. The government body issued a notice on July 10 stating an eme
- Policy
- Nine out of 27 patients in Remdesivir improved
- by Kim, Jung-Ju Jul 14, 2020 06:12am
- Of the 27 COVID-19 patients in Korea who took Remdesivir, 9 cases improved out of 27 patients with severe change. The positive effect was about 30%, which is only a numerical example and is still under professional review. Deputy General Manager Kwon Joon-Wook, the Central Disease Control Headquarters of the KCDC (Director, Eun-kyeong J
