- Policy
- The vaccination date of AZ’s vaccine will be advanced
- by Lee, Jeong-Hwan Jan 6, 2021 06:19am
- The MFDS announced that it will accelerate the marketing approval period as much as possible by approval/review process of AstraZeneca's COVID-19 vaccine, which was accepted for approval on the 4th, and the national lot release at same time. The approval/review system takes up to 40 days and lot release takes up to 20 days, but it is techn
- Policy
- Prostate cancer treatment Erleada by Janssen was approved
- by Lee, Tak-Sun Jan 6, 2021 06:19am
- Janssen Korea has received domestic approval for a new prostate cancer drug. The emergence of new options after Zytiga (Abiraterone acetate) is expected to expand its influence in the prostate cancer treatment market. The MFDS approved Janssen's Erleada (Apalutamide) in Korea on the 30th. It is approved as a combination therapy with andro
- Policy
- AZ has applied for domestic approval of COVID-19 vaccine
- by Lee, Tak-Sun Jan 5, 2021 05:18pm
- The MFDS announced today (4th) that AstraZeneca Korea's application for item approval for COVID-19 vaccine (code name: AZD1222) has been received. This vaccine is a 'viral vector vaccine' manufactured by putting COVID-19 surface antigen gene into a chimpanzee adenovirus vector. Viral vector vaccines are manufactured by inserting viral ant
- Policy
- Generics for Arcoxia are coming soon
- by Lee, Tak-Sun Jan 4, 2021 05:58am
- Generic for Arcoxia, COX-2 anti-inflammatory analgesic is expected to be released soon. As the PMS ended on the 22nd of last month, it was confirmed that the generic company received the application on the 23rd, the next day. Since generic companies have already confirmed patent avoidance, they are expected to market their products as so
- Policy
- Contract for 20 million people with Moderna was completed
- by Lee, Jeong-Hwan Jan 4, 2021 05:55am
- The government officially announced today (31) that it has signed a contract to purchase 20 million COVID-19 vaccines with Moderna, a US pharmaceutical company. As a result, Korea has secured the quantity of Moderna vaccines before the end of this year. This amount exceeds 100% of the population of Korea, and it is evaluated that it is su
- Policy
- GBP510 by SK Bioscience has been clinically approved
- by Lee, Tak-Sun Jan 4, 2021 05:55am
- Another COVID-19 vaccine developed by SK Bioscience has been approved for clinical trials in Korea. The MFDS announced on the 31st that it has approved the clinical trial of the domestically developed COVID-19 vaccine GBP510. GBP510 is a vaccine candidate being developed by SK Bioscience and is different from NBP2001, which was clinically approv
- Policy
- Review of new evaluation index for innovative certification
- by Lee, Jeong-Hwan Dec 31, 2020 06:20am
- When the MOHW is certified as an Innovative Pharmaceutical Company, it is expected to initiate a reorganization of the system to create new evaluation indicators that take into account the characteristics of overseas pharmaceutical companies. The goal is to establish a pharmaceutical and bio environment that provides a basis for domestic i
- Policy
- Item management of accelerated approval is strengthened
- by Lee, Tak-Sun Dec 31, 2020 06:20am
- The MFDS has established a policy that it will not approve the extension of the deadline if the clinical trial is unsatisfactory for phase III accelerated approval item. Periodic reports should be submitted in the middle of Phase III, and surveys will be conducted if necessary for items with no results. It was to supplement this by crea
- Policy
- Benlysta is about to be listed as RSA (Refund·Expenditure)
- by Kim, Jung-Ju Dec 31, 2020 06:19am
- Benlysta (Belimumab), a new treatment for systemic lupus erythematosus by GSK, can be listed on the ‘Pharmaceutical Benefit List and Upper Limit Price List’ in February next year as soon as the administrative procedures are carried out sequentially. According to the pharmaceutical industry on the 28th, the government will promote insurance
- Policy
- Generic for Teribone was approved & the competition began
- by Lee, Tak-Sun Dec 30, 2020 06:02am
- As a treatment for osteoporosis, generics have begun to be released in the latest bone formation promoting agents. Following Lilly's Forsteo, Dong-A ST's Teribone was also a generic version. The MFDS approved Terrosa 56.5μg (Teriparatide acetate) from BMIKOREA on the 28th. Terrosa is a generic of Teribone subcutaneous injection 56.5 μg
