- 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
- Company
- Celltrion's self-test kit has been approved for EUA
- by Chon, Seung-Hyun Oct 27, 2021 05:49am
- Celltrion announced on the 25th that the COVID-19 antigen rapid self-test kit DiaTrust COVID-19 Ag Home Test, jointly developed with Humasis recently acquired Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Celltrion received the EUA of Celltrion DiaTrust™ COVID-19 Ag Rapid Test for Professionals from the FDA
- Company
- Sales of choline alfoscerate rise despite controversy
- by Chon, Seung-Hyun Oct 26, 2021 05:53am
- Sales of brain function enhancer ‘choline alfoscerate’ are on the rise in the prescription drug market. The drug recorded growth for 3 consecutive quarters despite controversy over its efficacy, reduced scope of reimbursement, and the restitution of insurance benefits. Also, with many CA products withdrawing from the market after giving up cl
- 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
- Company
- Merck will actively support Korea to become one of the top 5
- by Oct 26, 2021 05:53am
- M Lab has promised to actively invest and expand cooperation with domestic companies to expand its capabilities in Korean vaccine production and bio-process. In an online press conference hosted to commemorate the 5th anniversary of its establishment on the 21st, M Lab said, "We will support Korea to leap into one of the top five global vacc
- Company
- ‘Brilinta’ generic to be released next month
- by Kim, Jin-Gu Oct 25, 2021 05:50am
- Generics of AstraZeneca’s oral antiplatelet therapy Brilinta will be released next month. However, only 6 of the 25 companies that received first generic exclusivity will be releasing actual products. The small number of releases is interpreted to be caused by the domestic companies' declining interest in Brilintagenerics. According t
- Opinion
- [Desk's view] It should also prepare for "With Corona"
- by Chon, Seung-Hyun Oct 25, 2021 05:50am
- The government has announced that it will shift the COVID-19 quarantine system to a "step-by-step daily recovery" (with COVID-19) centered on the management of the number of critically ill patients or deaths. As the proportion of COVID-19 vaccination completion exceeds 70%, a relaxed quarantine system such as lifting restrictions on operating
- 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
