- Policy
- The KDCA has set aside ₩299.2 billion for COVID-19 tx
- by Kim, Jung-Ju Dec 16, 2021 05:51am
- The KDCA (Chief Jeong Eun-kyeong) announced that it had decided at a Cabinet meeting on the 14th to &8361;299.2 billion as a reserve for additional purchases of COVID-19 treatments. It is equivalent to &8361;192 billion for oral treatment of COVID-19, &8361;107.2 billion for antiviral drugs (Remdesivir) and antibody therapy (Regkirona),
- Policy
- Exempt PVA for drugs with claims less than ₩10 billion
- by Lee, Hye-Kyung Dec 16, 2021 05:51am
- The pharmaceutical industry officially delivered its position that it cannot accept any of the measures set for the improvement of the detailed guidelines for the Price-Volume Agreement negotiations that were disclosed by the National Health Insurance Service. The NHIS had collected industry opinion until the 14th after disclosing the propose
- Policy
- Janssen keeps the Tylenol name for its imported product
- by Lee, Tak-Sun Dec 16, 2021 05:51am
- As expected, Janssen is keeping its brand name, ‘Tylenol,' for its antipyretic analgesic. The company had dropped the license of its domestically manufactured Tylenol Tab. 500mg in line with the shutdown of its Hyangnam plant and changed the name of its imported item that was approved in August to ‘Tylenol Tab. 500mg.’ The expectations
- Policy
- Moderna Korea has obtained permission for sales
- by Lee, Tak-Sun Dec 15, 2021 05:52am
- On the 13th, Moderna Korea, which was approved for Spikevax, an mRNA-based COVID-19 vaccine commissioned by Samsung Biologics, was approved for the ninth time in Korea as a "medical consignment manufacturing and sales business." According to the MFDS on the 14th, Moderna Korea acquired a drug consignment manufacturing and sales business at
- Policy
- The project to expand the age of NIP will be implemented
- by Lee, Jeong-Hwan Dec 14, 2021 05:58am
- The project to expand the age of free vaccination (NIP) against human papillomavirus (HPV) promised by President Moon Jae In will be implemented within the first quarter of next year. The KDCA plans to implement it immediately as soon as the notification revision process necessary for expanding the subject of HPV vaccine NIP is completed betw
- Policy
- Promotion of legislation to expand HPV vaccine NIP to boys
- by Lee, Jeong-Hwan Dec 14, 2021 05:57am
- Following the ruling party, the opposition party will also push for a bill to expand the NIP range of HPV (human papilloma virus) vaccines from girls to boys. Currently, the target of HPV vaccine NIP is 12-year-old girls, and the legislative goal is to prevent diseases caused by HPV such as cervical cancer by expanding them to "11-year-old an
- Policy
- A clinical study on CAR-T tx at SNUH has been approved
- by Kim, Jung-Ju Dec 14, 2021 05:56am
- A clinical study at Seoul National University Hospital for CART-T (Chimeric Antigen Recepter-T cell) treatment for pediatric leukemia patients was first approved. This is the first approval since the enforcement of the "The Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals” (hereinafter Advan
- Policy
- 241 items of the impurity detected Losartan were recovered
- by Lee, Tak-Sun Dec 14, 2021 05:56am
- Azido impurities are detected in Losartan, HTN treatment , and all 241 items are recovered, and only some manufacturing numbers of 54 items are recovered. However, 11 items are sold as they are because impurities are not detected excessively. The MFDS explained that the risk of harm to the human body is very low, but in the case of pati
- Policy
- Phase III for Amivantamab-Lazertinib was approved
- by Lee, Tak-Sun Dec 13, 2021 05:57am
- Lazertinib was exported to Janssen in 2018 worth 1.4 trillion won. Janssen is attempting to overcome existing treatments through the combination of its developed non-small cell lung cancer treatment "Amivantamab (Rybrevant)" and Lazertinib. The MFDS approved a phase 3 clinical trial plan for "JNJ-61186372" applied by Janssen Korea on the 1
- Policy
- MFDS is considering changing the permission of Remdesivir
- by Lee, Tak-Sun Dec 13, 2021 05:56am
- Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, som
