- Policy
- 26 million flu vaccines will be released this year
- by Lee, Tak-Sun Jun 22, 2020 06:08am
- It is expected that 26 million flu vaccines will be released this year. The MFDS is planning to cooperate closely with the industry in preparation for an increase in demand for inoculation due to the prevalence of COVID-19 and the flu at the same time in the second half of the year. On the 18th, the MFDS announced that it will hold a briefing
- Policy
- What is the solution for Remdesivir/generic competitiveness?
- by Lee, Tak-Sun Jun 19, 2020 06:21am
- There was no communication between the MFDS and the pharmaceutical industry due to the COVID-19 crisis that began in Korea from the end of January. Since the 'Director of pharmaceutical safety bureau at the MFDS-CEO Meeting in 2020' was postponed indefinitely on February 12, the news of the MFDS was only occasionally available through data
- Policy
- Lee Nak-yeon, would continue to support COVID-19 development
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- Chairman Lee Nak-yeon urged the MOHW and the MFDS to fully compensate for the cost of R&D so that domestic COVID-19 vaccines and therapeutics can contribute to the world. On the 17th, Chairman Lee attended the 'One-Health Strategy Debate on Future Infectious Diseases X' hosted by the Democratic Party of Korea’s COVID-19 National Overcomin
- Policy
- Dexamethasone would be difficult to use as direct treatment
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- While Dexamethasone focused global attention as a candidate for the COVID-19 treatment, the government decided that Dexamethasone would be difficult to use as a direct treatment. The government explained that Dexamethasone, which is considered a relatively old drug, is used to alleviate severe inflammation rather than directly treating COV
- Policy
- Tagrisso, approved phase III clinical trial
- by Lee, Tak-Sun Jun 18, 2020 06:28am
- Tagrisso, the third-generation medicine for metastatic non-small cell lung cancer with certain types of abnormal EGFR genes is gradually expanding its treatment area. Recently, the results of Phase III clinical trial that proved the effectiveness of Tagrisso as an adjuvant therapy after surgery were released at the American Society of Cli
- Policy
- What criteria did it decide whether to introduce Kaletra?
- by Kim, Jung-Ju Jun 18, 2020 06:28am
- What criteria did the government decide whether to introduce Remdesivir and Kaletra, which are used internationally as a treatment for 'COVID-19'? The government explained that the US FDA recently canceled the Hydroxychloroquine's emergency use of 'COVID-19' and that Korea is also considering whether to introduce it in consideration of the
- Policy
- MFDS, published COVID-19 vaccine clinical trial guidelines
- by Lee, Tak-Sun Jun 18, 2020 06:28am
- The MFDS announced on the 16th that it has published guidelines to help early entry into the clinical trial of COVID-19 vaccine and support its commercialization. The main contents are: ▲requirements for quality data of clinical trial drugs ▲considerations for non-clinical studies such as toxicity tests cConsiderations for the first clinica
- Policy
- MFDS talks of choline alfoscerate efficacy reevaluation
- by Lee, Tak-Sun Jun 17, 2020 06:22am
- Director Kim Young-ok of Pharmaceutical Safety Bureau at Ministry of Food and Drug Safety (MFDS) explained that the efficacy reevaluation on cognitive enhancer choline alfoscerate is in progress according to the principle, and the Central Pharmaceutical Affairs Deliberation Committee would assess the need for the clinical efficacy reevaluati
- Policy
- DAA Daklinza and Sunvepra to be pulled out from Korea
- by Lee, Tak-Sun Jun 17, 2020 06:21am
- ‘Daklinza plus Sunvepra,’ the first direct acting antivirals (DAA) in Korea praised to have opened the era of ‘curable hepatitis C,’ would be withdrawn from the Korean market after five years since the launch. Bristol Myers Squibb (BMS) Korea, a supplier of the drug in Korea, has recently reported Ministry of Food and Drug Safety (MFD
- Policy
- Phase III trial of Eylea biosimilar is ready to kick off
- by Lee, Tak-Sun Jun 16, 2020 06:20am
- Samsung Bioepis is accelerating the development of a macular degeneration treatment, Eylea biosimilar (Aflibercept, Bayer Korea). The development stage is the most advanced in Korea. On the 11th, the MFDS approved phase III global clinical trials for Eylea biosimilar ‘SB15’ by Samsung Bioepis It is phase III trial comparing the ef
