- Company
- SGLT-2i Jardiance adds chronic heart failure indication
- by Eo, Yun-Ho Nov 30, 2021 05:52am
- The SGLT-2 inhibitor ‘Jardiance’ may now be prescribed for chronic heart failure in Korea as well. According to industry sources, the Ministry of Food and Drug Safety had additionally approved a new indication for Jardiance (empagliflozin),' the SGLT-2 inhibitor used for the treatment of diabetes, to be used for adults with chronic hea
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited on
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anti
- Opinion
- [Reporter’s View] On the best way to issue impurity recalls
- by Lee, Tak-Sun Nov 29, 2021 05:58am
- Once again, impurities were detected in the losartan ingredient of antihypertensive drugs that are being used by many patients. Some pharmaceutical companies have already started product recalls under orders from the Ministry of Food and Safety. With the results of the companies’ impurity investigations being released one after another,
- Company
- Ildong started developing a treatment for COVID-19
- by Nho, Byung Chul Nov 29, 2021 05:58am
- Ildong Pharmaceutical and Shionogi Pharmaceutical have begun joint development of oral COVID-19 treatments, drawing keen attention to whether they will succeed in commercializing them in the future. Ildong Pharmaceutical officially announced on the 17th that it will participate in the development of S-217622 as a candidate for oral COVID-1
- Policy
- A new pre-approval system for Ultomiris was established
- by Lee, Hye-Kyung Nov 29, 2021 05:58am
- The pre-approval application system for Ultomiris, a treatment for night hemoglobin (PNH) in Handok, has just been established. The HIRA recently established a new Ultomiris pre-approval application system in the nursing institution business portal. The application for pre-approval of Ultomiris is in the same position as Soliris, which is previo
- Company
- Samsung BIOEPIS set a new sales record in a year
- by Chon, Seung-Hyun Nov 29, 2021 05:58am
- Samsung BIOEPIS has generated the largest quarterly sales since its launch. Overseas sales of biosimilars have increased, and milestones have flowed in due to overseas permits for subsequent biosimilar products. According to the Financial Supervisory Service on the 23rd, SAMSUNG BIOEPIS saw its sales rise 14.4% year-on-year to 271 billion won
- Company
- Keytruda's sales have been leading for two consecutive years
- by Chon, Seung-Hyun Nov 26, 2021 05:54am
- Keytruda, an immuno-cancer drug, has been leading the domestic pharmaceutical market for the second consecutive year. K-CAB continued to soar among new drugs from multinational pharmaceutical companies. According to IQVIA, a pharmaceutical research institute on the 26th, Keytruda of MSD Korea recorded 145.5 billion won in sales in the third q
- Policy
- Winner of pricing suits will be compensated for damages
- by Kim, Jung-Ju Nov 26, 2021 05:54am
- The countless litigations between government and companies regarding reimbursements such as drug price cuts or reduced scope of reimbursement are causing wasteful losses to both parties. On this, the government and the National Assembly have been proposing various solutions to prevent excessive stay of executions. The NA has proposed a
- Company
- Will the sale of impurity Losartan be okay?
- by Kim, Jin-Gu Nov 26, 2021 05:53am
- It is focusing on announcing the results of the MFDS. Anxiety in production and sales sites surrounding Losartan impurities is rising. As self-inspection results begin to come out for each manufacturer, consignment companies that received these results are agonizing over whether to preemptively suspend sales or continue sales. According to
