- Policy
- Movizolo Tab subject to drug shortage prevention program
- by Lee, Tak-Sun Dec 27, 2024 05:56am
- Pharmbio Korea’s Movizolo Tab, a prucalopride succinate-based drug used to treat chronic constipation, will be designated as a drug shortage prevention drug, resulting in an increase in drug price. Until now, prucalopride-based drugs have faced supply challenges due to low drug prices. According to industry sources on January 26, Ph
- Policy
- "Viread generic have saved KRW 400B in drug cost over 9 yrs"
- by Lee, Hye-Kyung Dec 27, 2024 05:56am
- It has been reported that market entries of 84 generics, which obtained priority marketing authorization, for 12 pharmaceuticals listed between 2015 and 2023 have saved medication costs of KRW 804.2 billion. Specifically, it lowered the listed pharmaceutical costs by KRW 536.3 billion and saved through drug substitution by KRW 267.9 billion,
- Policy
- Generic verision of Citus Tab will be reimb-listed next mo.
- by Lee, Tak-Sun Dec 27, 2024 05:55am
- The generic version of 'Citus Tab,' SAMA Pharm's treatment for respiratory asthma and allergic rhinitis, will be reimbursement listed in January 2025 for the first time. Four pharmaceutical companies, including Dasan Pharmaceutical, are set to enter the market early through patent avoidance. According to industry sources on December 26
- Policy
- MFDS' drug data protection to be implemented next year
- by Lee, Hye-Kyung Dec 24, 2024 06:22am
- Starting next year, innovative new drugs (IND) or those developed with new indications will have their approval data protected for up to six years, drawing attention to whether this will encourage domestic pharmaceutical companies to conduct more clinical trials. The Ministry of Food and Drug Safety (MFDS) will implement the Pharmaceutical Da
- Policy
- Original 'Otezla' withdraws, whereas 5 generics get listed
- by Lee, Tak-Sun Dec 23, 2024 05:50am
- Generics to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, will be reimbursed starting January 2025. The ceiling price has been set as KRW 5,840 per tablet. According to industry sources on December 20, Dong-A ST's 'Otelia,' Daeowoong Pharmaceutical's 'Apsola,' Chong Kun Dang's 'Otebell,' Dongkoo Bio
- Policy
- New drug approval fees to increase next year
- by Lee, Hye-Kyung Dec 23, 2024 05:50am
- The Ministry of Food and Drug Safety has completed preparations to raise the fee for new drug approvals to KRW 410 million from January 1 next year. Since mid-October, the agency has formed the ‘Consultative Body for Discussions on New Drug Approval and Review Procedures' and completed the 'New Drug Approval and Review Business Procedures (G
- Policy
- Daewoong to replace Astellas Irribow’s gap
- by Lee, Hye-Kyung Dec 23, 2024 05:49am
- Daewoong Pharmaceutical has filled the gap for Astellas Korea’s diarrhea-type irritable bowel syndrome treatment Irribow (ramosetron hydrochloride), which was discontinued in February this year. The Ministry of Food and Drug Safety approved Daewoong Pharmaceutical's Irricol Tab 2.5㎍ (ramosetron hydrochloride) on the 20th. This follows D
- Policy
- Price of Pulmicort raised again upon request
- by Lee, Tak-Sun Dec 23, 2024 05:49am
- The price of asthma and bronchitis drug ‘Pulmicort Respule Nubuliser Suspension (budesonide, AZ), which had been raised in December last year, will again be raised in just one year. The move is intended to proactively address the drug’s global market shortage. According to industry sources on the 20th, the insurance price ceiling for
- Policy
- Gilead starts trial for its autoimmune disease drug in KOR
- by Lee, Hye-Kyung Dec 20, 2024 05:47am
- The B- and T-Lymphocyte Attenuator (BTLA) autoimmune disease treatment will enter clinical trials in Korea. The Ministry of Food and Drug Safety approved Gilead Sciences' application for a ‘multicenter, randomized, placebo-controlled Phase 1b clinical trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and phar
- Policy
- Keytruda’s reimb for gastric cancer will be redeliberated
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- The application to expand the gastric cancer indication for the immuno-oncology drug Keytruda (pembrolizumab, MSD) has been given a ‘redliberation’ decision. The drug is currently seeking reimbursement for 17 indications, but financial issues have prevented a conclusion. The Health Insurance Review and Assessment Service’s Cancer Disea
