- Policy
- New dementia drug Leqembi’s approval imminent in Korea
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The marketing authorization for Leqembi (lecanemab), the first drug to slow the progression of Alzheimer's disease, is imminent in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review of ‘Leqembi (lecanemab),’ a new drug for Alzheimer's disease that was co-
- Policy
- SGLT-2 monotherapy 'Suglat' set to withdraw from KOR
- by Lee, Tak-Sun May 13, 2024 05:51am
- The SGLT-2 inhibitor 'Suglat tab 50 mg (Ipragliflozin L-Proline),' which is used as monotherapy, will no longer be available in the market in South Korea. Three SGLT-2 monotherapies that were imported will be withdrawn from the Korean market, as Steglatro and Forxiga are set to be withdrawn. According to the Ministry of Food and Drug
- Policy
- 'BIO KOREA 2024' begins
- by Lee, Hye-Kyung May 10, 2024 05:47am
- 'BIO KOREA 2024' will be held on May 8-May10 for three days at Coex, Seoul. The conference is co-organized by the Korea Health Industry Development Institute (President Soon-do Cha, referred to as KHIDI) and Chungcheongbuk-do Province (Mayor Young Hwan Kim, referred to as Chungbuk), and sponsored by the Ministry of Health and Welfare (MOHW).
- Policy
- Celltrion Pharm completes localizing 3 Edarbi products
- by Lee, Hye-Kyung May 9, 2024 05:52am
- Celltrion Pharm has completed the localization of Edarbi Tab (azilsartan medoxomil potassium), a treatment for essential hypertension. On the 8th, the Ministry of Food and Drug Safety (MFDS) simultaneously withdrew and approved the authorization of Celltrion Pharm's Edarbi Tab 20mg. In December 2020, Celltrion Pharm acquired the entire
- Policy
- Name of transferred and aquired drugs can be changed in KOR
- by Lee, Hye-Kyung May 9, 2024 05:52am
- Korea’s regulations now stipulate that brand names of a drug transferred to a different company can be changed. According to industry sources on the 7th, the Ministry of Food and Drug Safety recently announced the revision of the 'Casebook for Drug Product Naming Practices (Citizen's Guide)' and announced the allowance of brand name changes.
- Policy
- AZ renews orphan drug Strensiq’s risk-sharing agreement
- by Lee, Tak-Sun May 9, 2024 05:52am
- The risk-sharing agreement (RSA) for Strensiq Inj (asfotase alfa, AZ), a treatment for hypophosphatasia, has been successfully renewed in Korea. The drug was last covered under the RSA scheme in June 2020, when it was listed for reimbursement in Korea under the Expenditure Cap Type and Refund Type RSA. According to the National Health
- Policy
- MSD’s Cancidas will retain premium pricing for up to 5 yrs
- by Lee, Tak-Sun May 8, 2024 05:48am
- MSD's antifungal injection Cancidas’s premium pricing will be maintained for 5 years after generic entry. Originally, the price should have been adjusted to 53.55% of the highest price, but for various reasons, its price has remained at the level of 70% of the highest price. According to the industry sources on the 6th, Cancidas’s drug
- Policy
- Will oral anemia drugs for dialysis patients be reimbursed?
- by Lee, Tak-Sun May 7, 2024 05:50am
- Industry interest in rising on whether oral treatments used to treat anemia in dialysis patients will be covered by health insurance in Korea. The drugs have long been approved in Korea since 2020, but one of the products recently withdrew its license. The other two have yet to be reviewed for reimbursement, raising interest. According
- Policy
- Handok’s imported PNH drug Empaveli is approved in Korea
- by Lee, Hye-Kyung May 3, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS) announced on the 29th that it has approved Handok's imported new drug Empaveli Inj (pegcetacoplan). Empaveli binds to complement proteins C3a and C3b and inhibits the complement chain reaction, inhibiting intravascular and extravascular hemolysis. The drug is expected to help expand treatment o
- Policy
- AZ wins nod for new breast cancer drug 'Tiroo Cap Tab'
- by Lee, Hye-Kyung May 3, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) stated that it has granted AstraZeneca Korea’s new breast cancer drug 'Tiroo Cap Tab (capivasertib)' on April 29th. Capivasertib inhibits the activation of AKT protein, a serine·threonine kinase. Thus, it blocks the intracellular signaling pathway, preventing the sur
