- Policy
- Will the 37th new drug in Korea receive approval?
- by Lee, Hye-Kyung Apr 22, 2024 05:45am
- The approval for the 37th new drug in Korea is approaching. According to industry sources on the 22th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy assessment of the three zastaprazan-containing products from Onconic Therapeutic, Jeil Healthscience, and Jeil Pharmaceutical. The completion of the safet
- Company
- Will Padcev be deemed cost-effective and receive DREC review
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- Whether the reimbursement discussions for Padcev, a new antibody-drug conjugate for bladder cancer, will make progress is gaining attention. According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin), which passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in February, has
- Policy
- Reimb expansions of Keytruda have failed the 4th CDRC
- by Lee, Tak-Sun Apr 19, 2024 06:24am
- Keytruda’s reimbursement expansion item did not cross the Cancer Disease Review Committee (CDRC) threshold for the fourth time following its expansion in June last year. The analysis is that this attempt is particularly significant as all 15 indications were reviewed by the CDRC, and MSD’s financial contribution proposal was discussed f
- Company
- Global companies are affected by doctors’ resignation
- by Moon, sung-ho Apr 19, 2024 06:24am
- Two months have passed since the government announced its plan to raise the medical school quota by '2,000' students. Pharmaceutical companies are facing more marketing challenges amin the ongoing dispute between the medical community and the government. In particular, global pharmacies that launched new drugs after overcoming reimbursemen
- Policy
- Impurity detected in single-agent entacapones
- by Kang, Shin-Kook Apr 19, 2024 06:24am
- t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease. According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based
- Policy
- Four Otezla generics were authorized simultaneously in Korea
- by Lee, Hye-Kyung Apr 19, 2024 06:24am
- Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea. With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent see
- Company
- Adcetris’s IPS requirement for reimb may be removed
- by Eo, Yun-Ho Apr 19, 2024 06:23am
- A green light has been given for the removal of the IPS score requirement for Adcetris, which had been a long-standing wish of the patients. According to industry sources, Takeda Pharmaceutical Korea’s reimbursement expansion application to remove the International Prognostic Score (IPS) score criteria for prescribing its Adcetris (brent
- Company
- Drug exports escape ‘COVID-19 endemic slumps’ with botox
- by Kim, Jin-Gu Apr 19, 2024 06:23am
- The export values of drugs developed by Korean pharmaceutical companies increased 16% year-over-year in Q1. Compared to other quarters, it is the highest amount two years after Q1 of 2022. The export performances of domestic drugs had stagnated after the announcement of the endemic. However, the pharmaceutical industry has a positive outlook,
- Company
- Korean pharma companies accelerate global market entry
- by Heo, sung-kyu Apr 18, 2024 05:54am
- Domestic pharmaceutical companies are targeting the Southeast Asian and Latin American markets as a bridgehead to their entry into the global market. As these are still emerging markets, the companies believe that they can secure relative competitiveness in those markets. For this, the companies are exploring the market through various strate
- Policy
- PVA exemptions expanded to drugs below KRW 3 billion
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Effective this year, the price-volume agreement (PVA) criteria will be expanded to provide an exemption to products with a claim amount below KRW 3 billion. This amount represents an increase from the previous criteria, which was below KRW 2 billion. Also, any product that has undergone more than two price reductions in the last five yea
