- Policy
- Handok’s thrombocytopenia drug Doptelet approved in KOR
- by Lee, Hye-Kyung Nov 28, 2024 05:54am
- Handok's new rare disease drug ‘Doptelet (avatrombopag)' was approved in Korea on the 26th. The Ministry of Food and Drug Safety approved Doptelet as a treatment for thrombocytopenia for patients with liver disease. Handok is reaping the benefits of forging a strategic partnership with the global biopharmaceutical company Sobi-Handok
- Policy
- Lagevrio prescription age raised from 60 to 70
- by Kang, Shin-Kook Nov 28, 2024 05:54am
- The prescription age for the government-supplied COVID-19 treatment, Lagevrio, will be raised from 60 to 70 from the 27th.&160; According to the Korea Disease Control and Prevention Agency (KCDA), the three COVID-19 drugs (Paxlovid, Lagevrio, Veklury Inj) that were initially supplied by the government, were planned to be included in Korea’s
- Policy
- Limiting new drug patent term extensions would be beneficial
- by Lee, Jeong-Hwan Nov 25, 2024 05:53am
- The domestic pharmaceutical industry's attention is focused on whether the proposed amendment to the Patent Act, which would limit the drug patent term to 14 years and stipulate the number of patent rights that can be extended to one (singular), will pass the Bill Review Subcommittee of the National Assembly's Standing Committee review.
- Policy
- Once-weekly Icodec nears approval in Korea
- by Lee, Hye-Kyung Nov 25, 2024 05:53am
- A once-weekly insulin drug for diabetics is close to being approved in Korea.&160; According to the minutes of the Central Pharmaceutical Affairs Council meeting released by the Ministry of Food and Drug Safety (MFDS) on the 21st, the safety and efficacy feasibility of the basal insulin preparation was discussed. As a result of the delib
- Policy
- Academia requests reimb expansion for Perjeta, Verzenio
- by Lee, Tak-Sun Nov 25, 2024 05:53am
- Lymph node-positive patients will now be reimbursed for their use of the breast cancer drug Perjeta inj (pertuzumab, Roche).&160; The reimbursement extension was requested by the relevant medical societies and will take effect in December. It is interesting to note that the new criteria for reimbursement of anticancer drugs were establish
- Policy
- Korea’s 2nd GIFT drug Nefecon is approved in KOR
- by Lee, Hye-Kyung Nov 22, 2024 05:55am
- Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug, has been approved in Korea. The Ministry of Food and Drug Safety approved Nefecon on the 18th. Nefecon is used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who
- Policy
- CKD drug Kerendia seeks indication expansion in KOR
- by Lee, Hye-Kyung Nov 21, 2024 05:46am
- Bayer Korea's Kerendia (finerenone), which is used to treat adult patients with chronic kidney disease with type 2 diabetes, will enter Phase III clinical trials in Korea to expand its indication. On the 20th, the Ministry of Food and Drug Safety (MFDS), approved a ‘randomized clinical trial to determine the efficacy and safety of finere
- Policy
- Strengthed regulations on human drug use in vet clinics
- by Lee, Jeong-Hwan Nov 20, 2024 06:08am
- A bill that requires frontline pharmacies to record detailed distribution details on human specialty drugs sold to veterinary hospitals has passed the Bill Review Subcommittee review. Although there was a lot of disagreement over the bill between the professions subject to the regulation - the pharmacists and the veterinarians - the Healt
- Policy
- Stelara biosimilars face increasing competition
- by Lee, Tak-Sun Nov 20, 2024 06:08am
- Competition among biosimilars referencing Stelara (ustekinumab) for treating autoimmune diseases heats up. Samsung Bioepis added its biosimilar to the reimbursement list in July, and Celltrion added theirs in September. Since Celltrion is set to cut the price starting next month, attention has been drawn to future competition. According
- Policy
- Samil voluntarily cuts price of its Vemlino to lowest price
- by Lee, Tak-Sun Nov 19, 2024 06:13am
- Samil Pharm is voluntarily reducing the price of its hepatitis B drug Vemlino (Tenofovir Alafenamide Hemimalate). This will render the drug to be the lowest-priced drug among tenofovir alafenamide drugs, increasing its price competitiveness. According to industry sources on the 18th, the price of Vemlino will be reduced from KRW 2,425 t
