- Policy
- Eyes on approval of ‘acetaminophen+ ibuprofen’ combo OTCs
- by Lee, Tak-Sun May 14, 2021 05:50am
- The Ministry of Food and Drug Safety (MFDS) is reviewing the approval of an acetaminophen and ibuprofen combination therapy as an over-the-counter drug (OTC). The two ingredients are well-known antipyretic-analgesics, however, the combination of only these two ingredients was not commonly used as the two have different mechanisms of acti
- Policy
- MFDS has begun testing the second supply of AZ vaccine
- by Lee, Tak-Sun May 14, 2021 05:50am
- The MFDS has begun a national test on the second supply of AZ COVID-19 vaccines produced by SK Bioscience. The vaccine will be supplied 7.23 million doses from the 14th to early June. According to the MFDS on the 12th, SK Bioscience recently applied for a lot release for the second supply of AZ vaccine. The MFDS plans to approve the lot r
- Policy
- 835,000 doses of Covax AZ vaccines arriving tomorrow
- by Lee, Tak-Sun May 14, 2021 05:49am
- AstraZeneca vaccine produced in Italy will be introduced into Korea as a supply of Covax. Imported AZ vaccines are introduced through Emergency Use Authorization as they do not have domestic permission. The pan-government vaccine introduction TF (Team Leader: Kwon Deok-cheol, Minister of Health and Welfare) said 835,000 doses of the Covax Ast
- Policy
- The preventive effect of Moderna vaccine is 94%
- by Lee, Tak-Sun May 12, 2021 05:58am
- The MFDS' verification advisory group, consisting of outside experts, has recognized the prevention effect of Moderna COVID-19 vaccine for permission. The Central Pharmaceutical Affairs Review Committee, a court advisory body, will seek permission advice on the Moderna COVID-19 vaccine on Wednesday. COVID-19 vaccine safety and effective
- Policy
- Koselugo is about to be approved in Korea
- by Lee, Tak-Sun May 12, 2021 05:57am
- Koselugo (Selumetinib) is the FIRST and ONLY FDA-approved prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Koselugo is safe and effective in children under 2 years of age. And, it i
- Policy
- Dongkook develops new triple-drug combo for hypertension
- by Lee, Tak-Sun May 11, 2021 06:00am
- Dongkook Pharmaceutical has started the development of a single-pill, triple-drug combination that contains S amlodipine. Although two-drug combinations are already available, no triple-drug combination with a substance added for high blood pressure currently exists in the market. On the 10th, the Ministry of Food and Drug Safety approved
- Policy
- Clinical results for Janssen Vaccine to be submitted
- by Lee, Tak-Sun May 11, 2021 05:59am
- If Janssen COVID-19 Vaccine, the third-largest licensed clinical trial in Korea, is completed by the end of this year, the permits will also be subject to change. Janssen COVID-19 Vaccine was approved on April 7 for the prevention of COVID-19 in adults aged 18 and older. However it has not been officially introduced in South Korea yet.
- Policy
- Hemlibra is likely to establish criteria for reimbursement
- by Nho, Byung Chul May 11, 2021 05:59am
- Hemlibra's reimbursement standard applied in February this year is ▲for patients who fail ITI, ▲ if there is a doctor's opinion that it meets the requirements for ITI but cannot be implemented, and ▲approved only if antibodies are regenerated after ITI success. These benefits criteria could be cut from the HIRA's screening after prescribi
- Policy
- Korea United Pharm has started developing a combined IMD
- by Lee, Tak-Sun May 10, 2021 05:57am
- [ It is confirmed that Korea United Pharm has started developing a triglyceride treatment compound called "Pravastatin-Fenofibrate." The intention is to commercialize Fenofibric Acid, which can be taken with or without meals, as it is more convenient than conventional drugs. On the 28th of last month, the MFDS approved a Phase I clinical
- Policy
- 40 new drugs licensed last year
- by Lee, Tak-Sun May 7, 2021 06:01am
- Last year, a total of 40 new drugs were licensed in Korea, with five items manufactured by domestic pharmaceutical companies. One item of Yooyoung Pharmaceutical Co., Ltd.'s anti-arthritis treatment and four items of Hwanin Pharmaceutical Co., Ltd. were listed as new drugs. Rare drugs have also been licensed, up sharply from the previous year.
