- Policy
- MFDS cancels all Jeil’s hypertension drugs for fabrication
- by Lee, Tak-Sun Dec 21, 2021 06:05am
- The Ministry of Food and Drug Safety issued a disposition revoking the sales licenses of all hypertension drugs manufactured by Jeil Pharmaceutical after the company was found to have submitted fabricated data for approval. A total of 44 items from 15 companies including Jeil Pharmaceutical were issued the disposition. The GMP investigati
- Policy
- Korea tightens social distancing measures again
- by Kim, Jung-Ju Dec 20, 2021 06:11am
- The surge in COVID-19 cases in Korea has led the government to once again tighten the reins on social distancing while focusing on encouraging booster shot vaccinations. Private gatherings will be once again limited to no more than four people in all areas regardless of region, and a ‘vaccine pass’ that differs the level of restrictions
- Policy
- Jeil's JP-1366 has been approved for phase 3 in Korea
- by Lee, Tak-Sun Dec 16, 2021 05:51am
- Jeil's new drug candidate JP-1366 for GERD has been approved for phase 3 clinical trials and is speeding up commercialization. Currently, sales of HK inno.N's P-CAB-based new drug K-Cab are high in Korea. On the 14th, the MFDS approved a phase 3 clinical trial plan for JP-1366 applied by Onconic Theapeutics, a subsidiary of Jeil Pharmaceu
- 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
