- Policy
- Bayer begins development of high-dose of Eylea
- by Lee, Tak-Sun Aug 14, 2020 06:21am
- The competition between Bayer and Novartis for the treatment of age-related macular degeneration (AMD) is intensifying. After Novartis recently received approval in Korea for a new drug 'Beovu', which improved the number of doses, Bayer also began to develop a high-dose of Eylea that extended the dosing period. On the 11th, the MFDS appro
- Policy
- 1 out of 8 Koreans prescribed with narcotic anti-anxiety
- by Lee, Tak-Sun Aug 14, 2020 06:21am
- In last year alone, one out of eight people in South Korea have been prescribed with narcotic anti-anxiety medications. On Aug. 12, Ministry of Food and Drug Safety (MFDS) informed a pamphlet on ‘Safe Use of Narcotic Anti-anxiety Medication’ would be disseminated with the relevant information found from its big data analysis on the use of
- Policy
- The right age to use KRW 2.5 billion SMA drug Zolgensma
- by Lee, Tak-Sun Aug 13, 2020 06:27am
- Prior to the South Korean health authority’s approval on Zolgensma, known as the most expensive drug in the world, Central Pharmaceutical Affairs Deliberation Committee discussed the appropriate age of the drug user. The manufacturer Novartis has applied for an indication to treat patients under the age of two, but the committee conclud
- Policy
- There are 13 COVID-19 treatments in domestic clinical trials
- by Lee, Tak-Sun Aug 13, 2020 06:25am
- Currently, there are 9 antiviral drugs and 4 immunomodulatory drugs for COVID-19 treatments currently in clinical trials in Korea. As antiviral drugs and immunomodulatory drugs have different mechanisms of action, treatment methods are also different. The MFDS said that two clinical trials (Rebif, GX-I7) were added since the announcement on J
- Policy
- 74% relying on imported substance at risk amid COVID-19
- by Lee, Jeong-Hwan Aug 13, 2020 06:25am
- While the domestic self-sufficiency of pharmaceutical substance has been constantly falling and 74 percent of the industry is relying on overseas-imported substances, experts warn the South Korean pharmaceutical industry may be at risk when the substance supply gets unstable amid COVID-19. They advise the Korean government should set
- Policy
- 14 generics for Albendazole, were already approved this year
- by Lee, Tak-Sun Aug 12, 2020 06:00am
- Albendazole is on the rise this year. Albendazole is an anthelmintic ingredient that began to obtain domestic approval in the early 1980s, and only four products were approved from 2017 to 2019. However, as other effects other than the approval of Albendazole became known through social media, new licensed generics have rapidly increased t
- Policy
- Genexine, conducts clinical trials of 'GX-I7'
- by Lee, Tak-Sun Aug 12, 2020 05:59am
- Interleukin-7 anticancer drug candidate, being developed by Genexine, will conduct a clinical trial in Korea in patients with COVID-19. The MFDS announced on the 7th that it has approved a phase I clinical trial plan for 'GX-I7', a domestically developed COVID-19 treatment. As a result, there have been a total of 15 clinical trials (13 tr
- Policy
- Administrative court rules against Lilly on Forsteo pricing
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- The administrative court rejected Lilly Korea’s litigation against the government-authorized drug pricing reduction ordered due to the reimbursement listing of biosimilar. Lilly argued Daewon Pharmaceutical’s biosimilar Terosa cannot be considered equivalent to its original drug, the court rejected the argument. Accordingly, the up
- Policy
- GC Pharma begins clinical trial for new type of Fenofibrate
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- In the triglyceride treatment market, GC Pharma, which is running on top of the Fenofibrate 'Lipidil supra', has begun clinical trials for a new formulation of the same ingredient. It seems to be an attempt to improve the shortcomings of Lipidil supra, which should be taken after meals. The MFDS approved a phase I clinical trial protocol to e
- Policy
- The HIRA deliberated on benefits for Rinvoq & Kisqali
- by Kim, Jung-Ju Aug 11, 2020 06:02am
- The HIRA (Director Sun-min Kim) deliberated on the adequacy of benefits for these two new drugs at the Pharmaceutical Benefits Advisory Committee held on the 6th and concluded that AbbVie Korea's new drug for rheumatoid arthritis 'Rinvoq ER 15mg (Upadacitinib)' was to be eligible for reimbursement, and Novartis’ advanced or metastatic breast
