- Policy
- 'Symbenda' withdraws from Korean market 3 years after reimb.
- by Lee, Tak-Sun Oct 29, 2021 05:54am
- A blood cancer drug that took 7 years from approval to reimbursement is being removed from the market only 3 years since starting its sale in earnest. The company that sells the product has pointed to the termination of their agreement as to the cause of its market withdrawal, however, the analysis is that profitability has declined due to d
- Policy
- KDCA “will monitor development of oral COVID-19 treatments"
- by Lee, Hye-Kyung Oct 29, 2021 05:53am
- The government expressed its determination to introduce a safe treatment with verified efficacy by continuously monitoring the COVID-19 treatment trends, including the US Merck & Co. (MDS)'s oral COVID-19 treatment, 'molnupiravir .' That was the KDCA's response to when NA member Young-seuk Seo of the Democratic Party of Korea asked in vi
- Policy
- The government needs to create a sovereign wealth fund
- by Lee, Jeong-Hwan Oct 29, 2021 05:53am
- The National Assembly's Health and Welfare Committee urged both ruling and opposition parties to create tens to hundreds of trillion won worth of sovereign wealth funds to develop blockbuster vaccines and new drugs. As COVID-19 Pandemic has confirmed high demand in the global market for pharmaceutical and bio sectors such as vaccines and new
- 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
