- Policy
- Chong Kun Dang is approved for its Jardiance Duo latecomer
- by Lee, Tak-Sun Nov 16, 2021 05:52am
- Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ‘Jardiance Duo (empagliflozin-metformin hydrochloride). In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply f
- Policy
- Rx drugs,allowed according to CTD starting from next year
- by Lee, Tak-Sun Nov 15, 2021 05:56am
- The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards. The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting
- Policy
- More convenient new dementia treatments introduced to market
- by Lee, Tak-Sun Nov 12, 2021 05:54am
- With a series of new dementia treatments being approved in Korea, whether the market dominated by Aricept will falter is gaining attention. Aricept (donepezil hydrochloride, Eisai Korea) has been dominated the market with an 80% share in the Korean prescription market. The Ministry of Food and Safety approved Lundbeck Korea’s ‘Ebixa tab
- Policy
- Controversy rise over standards used in pricing negotiations
- by Moon, sung-ho Nov 11, 2021 06:00am
- “It may seem cruel for the smaller pharmaceutical companies, but it is important.” The National Health Insurance Services is expected to consider the ‘marketing and sales’ ability of pharmaceutical companies as a major criterion in estimating the ‘expected claims amount’ of the companies, which is an essential part in drug pricing negot
- Policy
- RWD & RWE will be important means of use in post-evaluation
- by Kim, Jung-Ju Nov 11, 2021 06:00am
- Limited replacement is appropriate as a means of supplementing proven RC The quality of the site, which will be the standard, such as standardization of medical records at hospitals where data will be calculated. The task of government insurance authorities and the private sector is to increase patient access to very expensive and innov
- Policy
- The MFDS consulted on Expedite Approval of COVID-19 PO
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- The MFDS announced that it is conducting consultations with the company for rapid domestic approval on overseas developed COVID-19 oral treatments on the verge of commercialization. In the case of Molnupiravir, an oral treatment for MSD, the government plans to gradually introduce 404,000 people through a pre-purchase contract in February
- Policy
- The National Assembly speeds up the telemedicine bill
- by Lee, Jeong-Hwan Nov 10, 2021 05:55am
- With the government declaring a phased COVID-19, the National Assembly's Health and Welfare Committee is speeding up its review of amendments to the medical law, which temporarily introduces non-face-to-face treatment. The Welfare Committee plans to propose two amendments to the medical law aimed at legislating telemedicine at the plenary ses
- Policy
- Moderna vaccine produced by SB has been applied
- by Lee, Tak-Sun Nov 9, 2021 05:53am
- The MFDS announced on the 8th that Moderna Korea has applied for permission to manufacture and sell the COVID-19 vaccine SPIKEVAX produced by Samsung Biologics in Korea. The vaccine induces an immune response by injecting antigen genes from COVID-19 in the form of mRNA to produce antigen proteins in the body. The MFDS announced that it wil
- Policy
- LG Chem seeks approval for its ‘Zemiglo+SGLT-2i’ combo
- by Lee, Tak-Sun Nov 9, 2021 05:53am
- LG Chem has applied for the marketing authorization of a combination drug that combines the DPP-4 diabetes treatment ‘Zemiglo (gemigliptin)’ with an SGLT-2 class inhibitor to the Ministry of Food and Drug Safety. With the new application, whether Zemiglo, one of the most successful locally developed novel drugs, will continue on its su
- Policy
- Will a recombinant flu vaccine be released in Korea, too?
- by Lee, Tak-Sun Nov 9, 2021 05:53am
- A gene recombinant influenza vaccine is expected to be released in Korea. Currently, flu vaccines made by using eggs or culturing cells are also on sale in Korea. The MFDS approved a phase 3 clinical trial plan for Sanofi's RIV4 vaccine on the 2nd. RIV4 is an abbreviation for Quardrivalent Recombinant Influenza Vaccine, which, in direct trans
