- Policy
- Imlunestrant becomes first reviewed after new drug approval
- by Lee, Hye-Kyung Feb 6, 2025 05:56am
- The first application for a new drug license has been submitted since the fee for drug approval was raised to KRW 410 million. According to industry sources on the 6th, the multinational pharmaceutical company Eli Lilly applied for an marketing authorization for its breast cancer drug 'Inrulio (imlunestrant)' to the Ministry of Food and D
- Policy
- Reimb imminent for switching between atopic dermatitis drugs
- by Lee, Tak-Sun Feb 5, 2025 05:53am
- Switching between atopic dermatitis drugs may be reimbursed soon. This is because the National Health Insurance Service has completed its review through the preliminary drug price reduction system, and all that remains is the National Health Insurance Service's negotiations. As the expected claim amount is not large, the negotiations are e
- Policy
- Low-dose nicergoline continues to be popular
- by Lee, Hye-Kyung Feb 5, 2025 05:52am
- Although it does not indicate the primary treatment of dementia, companies continue to receive approval for their low-dose nicergoline products. . The Ministry of Food and Drug Safety (MFDS) approved Reyon Pharm’s ‘Nicechol Tab. 10mg’ on the 3rd. This is the second approval this year, following the approval of the ‘Neurogoline Tab. 10mg’
- Policy
- 3-way race starts in faslodex mkt with new generic entry
- by Lee, Tak-Sun Feb 3, 2025 05:52am
- A new generic company entered the fulvestrant drug market that has been a battle between the original’s owner AstraZeneca and the first generic developer Boryung. The new entrant, Korus Pharm, will spark three-way competition in the market with its product being reimbursed this month. According to industry sources on the 31st, Korus
- Policy
- Will external reference pricing reevals be further delayed?
- by Lee, Jeong-Hwan Feb 3, 2025 05:52am
- The Ministry of Health and Welfare plans to concentrate on advancing the regulations on the post-management of generic drug pricing that are being redundantly implemented in Korea. Regarding the introduction of the external reference pricing that has been gaining industry-wide attention, the MOHW reaffirmed its stance on its necessity, but th
- Policy
- 'Lixiana' patent expires next year, good news for
- by Lee, Hye-Kyung Jan 24, 2025 05:51am
- As the patent of 'Lixiana (edoxaban),' a Direct Oral Anti-Coagulant (DOAC), is set to expire, generic companies are entering the competition. On January 21, the Ministry of Food and Drug Satefy (MFDS) approved bioequivalence tests, which are open-label, randomized, two groups, single time-point, cross-over Phase 2 trials involving healthy
- Policy
- Hokunalin Patch has been removed from Korea’s reimbursement
- by Lee, Tak-Sun Jan 24, 2025 05:51am
- Hokunalin Patch, asthma and bronchitis deodorant based on tulobuterol, will be removed from the reimbursement list. The move was made upon the expiry of the item’s marketing authorization last month. As a result, only domestic generic versions of the drug are available in South Korea. According to industry sources on Jan. 22, Abbott'
- Policy
- Govt plans to expand CDMO capacity by 2.5 times
- by Lee, Hye-Kyung Jan 24, 2025 05:51am
- The government plans to expand Korea’s CDMO manufacturing capacity 2.5 times by 2032 to become the No. 1 global CDMO by 2032. It will also support domestic companies with a 'megafund' by expanding the size of the K-Bio-Vaccine Fund, currently at KRW 600 billion, to over KRW 1 trillion. The government launched the National Bio Commission i
- Policy
- If atrial fibrillation develops, Rx 'Omega-3' API
- by Lee, Hye-Kyung Jan 23, 2025 05:54am
- The administration of the active ingredient 'omega-3-acid ethyl esters90,' which is used for treating dyslipidemia, will be permanently discontinued if a patient develops atrial fibrillation. Starting February 10, the Ministry of Food and Drug Safety (MFDS) will modify the approval specification based on the results of the European Medic
- Policy
- MFDS approves immune thrombocytopenia drug Tavalisse
- by Lee, Hye-Kyung Jan 23, 2025 05:54am
- The Ministry of Food and Drug Safety (MFDS) announced on the 20th that it has approved Tavalisse Tab 100 mg (fostamatinib sodium hydrate), an orphan drug used to treat immune thrombocytopenia in adults. Adult immune thrombocytopenia is an autoimmune disease in which antibodies against platelets are produced and platelets are destroyed in
