- Policy
- Patent protection for 42 yrs for Humira/32 yrs for Keytruda
- by Lee, Hye-Kyung May 16, 2023 09:07pm
- It was analyzed that Humira maintained its patent protection period for at least 42 years and Keytruda for at least 32 years after filing for material patents with the Evergreening patent strategy. Evergreening refers to extending the term of a patent or extending the term of a patent for more than 20 years in the case of a patent to obtain more
- Policy
- Biopharmaceutical CDMO annual average of ↑31%
- by Lee, Hye-Kyung May 15, 2023 05:41am
- Globally, the CDMO market for biopharmaceuticals is growing at an average annual rate of 31%. If this trend continues, the size of the Cell&Gene Therapy CDMO market is expected to reach 10 billion dollars in 2026. Kwon Soon-jae, managing director of ENCell, announced this at the 'CDMO Partnership for Acceleration of Biopharmaceutical Developm
- Policy
- Youkyung Oh was appointed as the first chairman of APFRAS
- by Lee, Hye-Kyung May 12, 2023 05:44am
- On the 10th and 11th, the Ministry of Food and Drug Safety (Minister Oh Yookyung) held the 1st Asia-Pacific Food Regulatory Authority Heads Consultative Meeting (APFRAS 2023), where 7 countries came together to harmonize global food regulations in the Asia-Pacific region and strengthen cooperation. said to have collected. APFRAS (Asia-Pacif
- Policy
- HIRA plans to report on the re-evaluation
- by Lee, Tak-Sun May 12, 2023 05:44am
- It is known that The HIRA will come up with a plan to improve the re-evaluation of drug benefits and report it to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare, which will be held this month. This improvement plan is based on the 'rationalization plan for re-evaluation of drug benefit adequacy', which end
- Policy
- Triple-negative breast cancer tx Trodelbi approved in Korea
- by Lee, Hye-Kyung May 11, 2023 05:50am
- Meditip's Trodelbi (Sacituzumabgovitecan), an orphan drug triple-negative breast cancer treatment, has received domestic product approval. The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced on the 9th that it had approved the approval of Trodelbi to be used in breast cancer patients who lack estrogen receptor (ER), progestero
- Policy
- ‘Pay more policy attention to advanced heart failures'
- by Hwang, byoung-woo May 11, 2023 05:49am
- [Interview with Medical Societies] Soo-Yong Lee, Administrative Secretary of the Insurance Committee at KSF Asks authorities to increase benefits for patients at high risk of health failure who have fewer treatment alternatives According to the ‘2020 Heart Failure Fact Sheet’ that was released by the Korean Society of Heart Failure (KSHF),
- Policy
- Rapidly changing breast cancer treatment
- by Choi, sun May 11, 2023 05:49am
- The Korean Breast Cancer Society revised the treatment recommendation on the 27th. Combination drug treatment using a combination of an antibody and an anticancer drug has emerged as a hot issue, and as the new anticancer drug Enhertu for HER2-positive metastatic breast cancer received domestic approval in September last year, the reflection of
- Policy
- A benefit study of the Gardasil 9 NIP is also forthcoming
- by Lee, Jeong-Hwan May 10, 2023 11:17pm
- The KDCA is ordering an additional policy research service to apply the National Vaccination Support Project (NIP) of the 'HPV 9-valent vaccine' to female adolescents and male adolescents over 12 years of age. As the result of the HPV 9 commissioned by KDCA to NECA earlier was found to be low in cost-effectiveness in vaccine research, it is
- Policy
- Prior HIRA approval is required to administer Crysvita
- by Lee, Tak-Sun May 10, 2023 06:00am
- Prior approval from the Health Insurance Review and Assessment Service will be required to administer the pediatric rickets treatment Crysvita Inj which is set to be reimbursed from May this year. Accordingly, HIRA has prepared the specifics for Crysvita’s prior approval and applied it from the 3rd of this month. According to the spe
- Policy
- Insurance price ceiling reeval results to be notified soon
- by Lee, Tak-Sun May 9, 2023 05:38am
- The Health Insurance Review and Assessment Service completed its first review on drugs subject to primary pricing ceiling reevaluations and will be notifying companies of the results soon. A 30-day objection period will follow HIRA’s result notification. According to HIRA on the 8th, HIRA’s Drug Reimbursement Evaluation Committee c
