- Policy
- Multinational companies have more drugs for PVA
- by Lee, Hye-Kyung Oct 28, 2021 05:58am
- The NHIS made an official position that it cannot accept the criticism that new domestic drugs are being reversely discriminated within the PVA. After the parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, The NHIS replied, "It cannot be regarded as reverse discrimination in domestic new drugs," when aske
- Policy
- Development of generics for DPP4+SGLT2 has begun
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The development of generics that combines "DPP-4 Inhibitors" and "SGLT-2 Inhibitors," which are not covered so far, is underway. This is because there are less than two years left until the end of the PMS, which can be approved for generics. Until now, the domestic market for DPP4+SGLT2 complex has not been formed due to benefit issues, but g
- Policy
- Samsung Bio’s Moderna vaccine receives GMP certification
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The Ministry of Food and Drug Safety issued a Certificate of GMP Compliance for Samsung Biologics manufacturing facility that will be producing Moderna’s COVID-19 vaccine after signing a contract manufacturing agreement with Moderna. With the GMP certification, discussions on the domestic supply of the vaccine are also expected to gain
- Policy
- Dongkook started developing Dukarb's IMD
- by Lee, Tak-Sun Oct 26, 2021 05:53am
- Boryung's Dukarb (Amlodipine Besylate+Fimasartan Potassium Trihydrate), which reexamination ends in May next year, is competitively developing. While multiple pharmaceutical companies such as DongKoo Bio have already begun developing generics, DongKook has also started developing IMD. On the 22nd, the MFDS approved Dongkook's phase 1 clin
- Policy
- Up to 500 ppl will be allowed at events from next month
- by Kim, Jung-Ju Oct 26, 2021 05:53am
- The government has set a three-phase strategy starting next month for the ‘Living with COVID-19’ era. The measure comes 1 year and 10 months since the government implemented disease control and prevention measures for COVID-19. In particular, events and gatherings of less than 100 people will be allowed starting next month, and temporary p
- Policy
- Hanmi Pharmaceutical's Esomezole Plus has been approved
- by Lee, Tak-Sun Oct 26, 2021 05:53am
- Competition is fierce with the emergence of Hanmi Pharmaceutical, which topped the PPI single-drug market. Hanmi Pharmaceutical's Esomezole Plus will launch in the highly competitive PPI+ antacids complex market. As Hanmi has a high market share with Esomezole, a single PPI drug, it is expected to cause significant changes in the current mark
- Policy
- HIRA “Will improve RSA and prior authorization system”
- by Lee, Hye-Kyung Oct 25, 2021 05:50am
- The increasing number of applications filed for reimbursement decisions on the use of ultra-high-priced new drugs, such as ‘Zolgensma’ and ‘Keytruda’ that cost 2.5 billion won and 500 million won per shot, respectively, has upped the National Assembly’s demand for the improvement of the Risk-sharing Agreement system (RSA) and prior au
- Policy
- Domestic approval for Pfizer's Cibinqo (PO) is imminent
- by Lee, Tak-Sun Oct 22, 2021 05:45am
- It was found that the domestic approval for oral atopic dermatitis treatment developed by Pfizer is imminent. This product is a JAK inhibitor in the same family as Xeljanz, which is used as a treatment for rheumatoid arthritis. As JAK inhibitors have recently obtained permission with atopy treatment indications one after another, it remains t
- Policy
- "Annual unused drug returns record ₩2.7 trillion”
- by Lee, Jeong-Hwan Oct 22, 2021 05:45am
- NA member and pharmacist Jung-sook Suh of the People Power Party urged the Ministry of Health and Welfare and the Ministry of Food and Drug Safety to present a specific solution to resolve the long-standing issue of ‘unused surplus inventory of drugs' in pharmacies. Currently, the burden of the unused surplus drugs is solely borne by the
- Policy
- There are expectations & concerns about ordering research
- by Lee, Jeong-Hwan Oct 22, 2021 05:44am
- While the government has ordered a study on preferential treatment for domestic new drugs developed by innovative pharmaceutical companies, domestic pharmaceutical companies with new drug technology are expressing both expectations and concerns at the same time. As the government accepts demands from the pharmaceutical industry and critic
