- Policy
- Fexclu priced at 90% of the weighted average of K-CAB+PPIs
- by Lee, Tak-Sun May 20, 2022 06:12am
- The price of ‘Fexclu Tab (fexuprazan), the potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease (GERD) treatment developed by Daewoong Pharmaceutical was set at 90% of the weighted average price of the same class drug ‘K-CAB (tegoprazan, HK Inno.N) and PPI (proton-pump inhibitors) drugs. On the 12th, the
- Policy
- The MFDS will gradually disclose the results of GMP survey
- by Lee, Hye-Kyung May 20, 2022 06:11am
- The MFDS has decided to disclose the results of the drug GMP survey on its website in the future. The MFDS has prepared a plan to disclose information on the results of the drug GMP survey based on the discussions discussed through the Public-Private Consultative Body on the Results of the GMP Survey. As a PIC/S member country, the results of
- Policy
- Green light to Sprycel's reimb with indication expansion
- by Lee, Tak-Sun May 20, 2022 06:11am
- The chronic myeloid leukemia treatment ‘Sprycel tab (dasatinib, BMS Korea)’ has received the green light to expand its reimbursement. The Health Insurance Review and Assessment Service announced that it had set the reimbursement standards for Sprycel in pediatric patients with acute lymphoblastic leukemia (ALL) at the 5th Cancer Disease Del
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of th
- Policy
- HIRA plans to improve the overall management system
- by Lee, Tak-Sun May 20, 2022 06:11am
- With the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system. Accordingly, it has been confirmed that internal research is being carried out. The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system. However
- Company
- The standard of Xospata is very disappointing
- by Eo, Yun-Ho May 19, 2022 05:51am
- Insurance benefits for the new leukemia drug Xospata have been applied, but clinics are expressing regret. Acute Myeloid Leukemia (AML) treatment Xospata has been reimbursed since March. Looking at the benefit criteria of this drug, remission-induction therapy is recognized in patients with FLT3 mutant acute myeloid leukemia who are refrac
- Company
- Samsung Bioepis makes ₩199.1 bil in Q1
- by Chon, Seung-Hyun May 19, 2022 05:51am
- Samsung Bioepis is off to a smooth start this year with a sharp rise in its biosimilar sales. According to the Korea Financial Supervisory Service, Samsung Bioepis recorded &8361;199.1 in Q1 sales this year, a 19.4% increase compared to the same quarter of the previous year. Also, the company’s net profit increased 11.5% to &8361;31.9 bill
- Company
- Samsung Bioepis’s Lucentis biosimilar approved in Korea
- by Lee, Seok-Jun May 18, 2022 10:42pm
- Samsung Bioepis became the first company to receive approval for a Lucentis biosimilar in Korea with ‘Amelivu (ranibizumab).’ Lucentis is a treatment developed by Genetech for ophthalmologic diseases such as macular degeneration and macular edema. With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Ko
- Policy
- 34 new global drugs, including Beleodaq, are urgently needed
- by Lee, Tak-Sun May 18, 2022 05:52am
- A study has been released that 34 new drugs, including the peripheral T-cell lymphoma treatment Beleodaq, are urgently needed to be introduced in Korea. These new drugs have not been introduced because they are judged to be insufficient in marketability due to domestic screening permits. KoNECT announced that it will select 34 new drugs th
- Opinion
- [Reporter’s View] New govnt signals expanded PE exemptions
- by Eo, Yun-Ho May 18, 2022 05:52am
- The inauguration of a new government brings hope and anticipation to each and every industry. The same goes for multinational pharmaceutical companies. In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme. Although many agendas remain in need of resolution, suc
