- Policy
- Chloroquine was approved for export due to COVID-19
- by Lee, Tak-Sun May 26, 2020 06:06am
- iUnder the influence of COVID-19, the approval of Chloroquine for export used as a therapeutic agent has been followed. It seems that domestic pharmaceutical companies are targeting overseas exports and making items due to the worldwide pandemic phenomenon. According to the MFDS on the 25th, permission to Chloroquine and Hydroxychloroquine
- Policy
- Will Vyleesi known as Viagra for women be released?
- by Lee, Tak-Sun May 26, 2020 06:05am
- A product known as Viagra for Women conducts clinical trials in Korea. It is Vyleesi (Bremelanotide, injection type) introduced by Kwangdong Pharmaceutical. The MFDS approved a clinical trial phase III bridging study plan by Kwangdong Pharmaceutical on the 22nd. Bridging study is a test to prove whether new drugs developed in foreign count
- Policy
- Virtual academic conferences consider e-booth as alternative
- by Kim, Jung-Ju May 25, 2020 06:26am
- Academic conferences in Korea are going through changes as many of academic events around the world are either canceled or postponed amid COVID-19 outbreak. While the medical experts predict the outbreak would not end anytime soon, a number of medical academia have either convened virtual conference or are planning on one to replace th
- Policy
- Concerta OROS'll be moved overseas to complete registration
- by Lee, Tak-Sun May 22, 2020 06:16am
- Janssen Korea, which decided to operate a domestic factory by 2021, is in a hurry to convert imports of licensed items. Following the transition to an overseas manufactory earlier this year, six items have been changed in permission, and in June, the manufacturing plant of the ADHD treatment, Concerta OROS ER will also be moved overseas to
- Policy
- COVID-19 vaccines/quarantine items road map details released
- by Kim, Jung-Ju May 22, 2020 06:16am
- The quarantine authorities will release a detailed road map for 'COVID-19' vaccine and quarantine products next week. Regarding vaccines, the area of greatest interest, R & D of nucleic acid vaccines, such as those under development by Moderna, is also actively being conducted in Korea. Kwon Joon-wook, deputy general manager of the Central
- Policy
- There are 17 cases of COVID-19 tx with stem cells worldwide
- by 박상준 May 21, 2020 06:01am
- As world-renowned pharmaceutical bio companies such as Gilead Sciences Korea, Novartis, and Pfizer have announced the development of COVID-19 treatment and vaccines, domestic pharmaceutical companies are also revealing their intentions through various mechanisms and strategies. In particular, it has attracted attention by offering various pos
- Policy
- Lilly’s Baricitinib begins clinical trial of COVID-19
- by Lee, Tak-Sun May 21, 2020 06:00am
- Global pharmaceutical company Eli Lilly's rheumatoid arthritis treatment, 'Baricitinib' (Olumiant) is conducting sponsor-investigator trials on COVID-19 patients. So far, 10 drugs have been approved for clinical trials in COVID-19 patients, including Baricitinib. The MFDS approved a sponsor-investigator trials investigating COVID-19 for
- Policy
- Consult with PM from the development to post-marketing stage
- by Lee, Tak-Sun May 20, 2020 06:11am
- The MFDS (Minister Eui-kyung Lee) expanded the role of the 'product manager (PM)', which has been limited to the permitting step, from the drug development to the post-marketing cycle, in order to increase the predictability of the approval and review process and safety management expertise. Announced on the 18th that it will switch to a one-sto
- Policy
- “Neglecting cost-effectiveness is dereliction of duty"
- by Kim, Jung-Ju May 19, 2020 06:07am
- Answering to the criticism that National Health Insurance (NHI) coverage enhancement initiative is toughening the barrier of pharmaceutical reimbursement listing and standard, Korean health authority officials urged the cost-effectiveness should be further reinforced. Recently appointed Director Yang Yoon Seok of the Pharmaceutical Benefit
- Policy
- Reimbursement on Ibrance-Faslodex available from June
- by Lee, Hye-Kyung May 19, 2020 06:07am
- From June 1, the healthcare reimbursement would be granted on the combined use of Pfizer Pharmaceutical Korea’s HER2-negative breast cancer treatment Ibrance (palbociclib) capsule and Faslodex (fulvestrant). National Health Insurance Service (NHIS) has settled on a negotiation over an indication expansion of the already listed drug and lis
