- Policy
- α-GPC's clinical re-evaluation will proceed in 3 groups
- by Lee, Tak-Sun Nov 20, 2020 06:15am
- While Korea United Pharm has visualized a separate clinical trial to verify the effect of 'mild cognitive impairment', Daewoong and Chong Kun Dang, which are ranked first and second in market sales, are expected to conduct clinical trials for all indications. The three companies plan to hold briefing sessions for related companies next week
- Policy
- The government is negotiating with Moderna & Pfizer
- by Kim, Jung-Ju Nov 20, 2020 06:11am
- The quarantine authorities plan to promote COVID-19 vaccine prior to next year's flu vaccination. In addition, it is said that negotiations are underway to purchase COVID-19 vaccines by Moderna and Pfizer, which showed excellent effects on prevention. Kwon Jun-wook, deputy chief at the Central Disease Control Headquarters, revealed the cur
- Policy
- Clinical re-evaluation is being reviewed for Formoterol
- by Lee, Tak-Sun Nov 19, 2020 06:10am
- The MFDS is reviewing a clinical re-evaluation of Formoterol Fumarate Hydrate tablets and syrups used to treat asthma. This is because the need for validation was raised during the renewal review process. However, the policy is to finalize the re-evaluation through the Central Pharmaceutical Affairs Review Committee. According to the MF
- Policy
- The use of antibiotics in Korea is 1.6 X that of the OECD
- by Kim, Jung-Ju Nov 18, 2020 07:59am
- The use of antibiotics in Korea was 1.6 times the average of OECD member countries in 2018. Of these, inadequate prescriptions such as antibiotics for colds account for 28%, so it is important to prevent resistance. The KDCA (Director Jeong Eun-kyeong) emphasized the adherence and practice of antibiotic resistance prevention rules to over
- Policy
- Multiple myeloma treatment 'Ninlaro' passed by the committee
- by Lee, Hye-Kyung Nov 17, 2020 06:27am
- Takeda Korea's multiple myeloma treatment'Ninlaro (Ixazomib)' passed the committee's deliberation. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical care benefits at the '11th Drug Benefit Evaluation Committee in 2020' on the 13th. The new drugs that have been deliberated on the adequac
- Policy
- Cyramza OS Clinical 9.6 months vs. RWE 7.9 months
- by Lee, Hye-Kyung Nov 17, 2020 06:26am
- Apparently a study in South Korea comparing the clinical trial result and real world data has found a targeted therapy for stomach cancer Cyramza (ramucirumab) and a targeted therapy for breast cancer Kadcyla (trastuzumab) have shorter overall survival in the real world. The clinical trial report on Cyramza stated its overall survival (OS) r
- Policy
- No.1 anticancer drug in Rx sales is Palonosetron & Tamoxifen
- by Lee, Hye-Kyung Nov 16, 2020 06:03am
- Based on the number of prescriptions, gastric cancer patients were prescribed 'Palonosetron' and breast cancer patients were prescribed 'Tamoxifen' the most. The HIRA released a retrospective study on preparing a platform for real-world evidence (RWE) for drug reimbursement management (Research Director Dr. Dongsuk Kim, Dr. Jihye Byun). This
- Policy
- Detailed review for COVID-19 tx budget are insufficient
- by Lee, Jeong-Hwan Nov 16, 2020 06:02am
- The National Assembly's Health and Welfare Committee was found to have insufficient details of the detailed review of the new budget of &8361;965 billion, which accounted for the largest volume of the COVID-19-related budget, before the resolution of the budget under its jurisdiction next year. Although it accounts for the highest budget
- Policy
- RWD is useful for shortening new drug's approval period
- by Lee, Hye-Kyung Nov 16, 2020 06:02am
- Opinion was raised that the use of RWD (Real Word Data) owned by The HIRA could accelerate and improve domestic drug development and new drug approval. Prof. Hyung-ki Lee and Ph.D student Yoo-min Jeon published their contributions in the HIRA Big Data Brief on the subject of 'The possibility of utilizing HIRA big data for efficient design,
- Policy
- COVID-19 vaccine likely to be approved w/o clinical trials
- by Lee, Tak-Sun Nov 16, 2020 06:02am
- The COVID-19 vaccine candidate material, which is showing a rapid pace in commercialization, is expected to undergo bridging study after the market because clinical trials are difficult in Korea. The clinical trial is difficult because, ironically, there are few COVID-19 confirmed cases in Korea. On the 10th, Pfizer USA and BioNTech, G
