- Policy
- The timing of approval for Novavax vaccine is unpredictable
- by Lee, Tak-Sun Jan 13, 2022 02:54pm
- The MFDS, which was active in disclosing information on COVID-19 vaccine screening, is suddenly not disclosing any information on the Novavax vaccine. There was no news of the expert advisory group, and 40 days have already passed the promised screening period. Some analysts say that this is because it is difficult for the MFDS to predict the
- Policy
- NHRC issues ‘expedited listing of Kymriah’ opinion to MOHW
- by Lee, Jeong-Hwan Jan 13, 2022 06:05am
- The National Human Rights Commission of Korea urged the Ministry of Health and Welfare on the need to expedite insurance listing of the CAR-T therapy ‘Kymriah’ that is used to treat leukemia and lymphoma. The NHRC’s position is that the government should set a temporary drug price with NHI coverage for drugs that are directly related t
- Policy
- Lee wants to cover infertility, contraception, HPV vaccines
- by Lee, Jeong-Hwan Jan 11, 2022 06:29am
- With the rising heat over the insurance coverage of hair loss treatments that was mentioned by presidential candidate Jae-Myn Lee, other healthcare-related election pledges made by the presidential candidates are also being reilluminated. Lee, who is planning to publically announce his pledge promising the insurance coverage of hair loss trea
- Policy
- Alopecia belongs to the health sector, benefits are possible
- by Lee, Jeong-Hwan Jan 11, 2022 06:29am
- Democratic Party of Korea's presidential candidate Lee Jae-myung claimed that the application of health insurance for hair loss treatments is a health pledge to alleviate public pain, and said he is reviewing the targets, ratios, and amounts through experts in the camp. He said that if pain relief is possible at an annual cost of around 10
- Policy
- 22 companies' Dapagliflozin+Sitaglipin were approved
- by Lee, Tak-Sun Jan 11, 2022 06:28am
- DongKoo Bio has obtained a number of drugs that are the same as the new diabetes drug "Dapagliflozin+Sitagliptin" approved on the 23rd of last month. A large number of consignment items produced by Dongkoo Bio have entered. Dapagliflozin+Sitaglipin is a new combination complex that has never been released before, but competition has become i
- Policy
- Chong Kun Dang applied for combination of Januvia+Forxiga
- by Lee, Tak-Sun Jan 10, 2022 11:40am
- A combination of diabetes treatments Januvia (Sitagliptin) and Forxiga (Dapagliflozin) is gaining popularity among domestic pharmaceutical companies. Although it can only be released after September next year due to patent rights issues, many domestic pharmaceutical companies are developing products. According to the pharmaceutical industry o
- Policy
- Will companies be able to apply for EUA for COVID-19 tx?
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- The development of COVID-19 treatments is actively progressing at home and abroad. Pfizer's oral treatment Paxlovid received EUA from the MFDS in December last year and is expected to be used in Korea soon. Currently, pharmaceutical companies that develop COVID-19 treatments are in a position to introduce them quickly in Korea through EUA lik
- Policy
- Remdesivir has been officially granted over the age of 12
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- The MFDS has approved the change to use Remdesivir, which was first approved as a treatment for COVID-19, only for those aged 12 or older. However, the EUA was decided for this age group to prevent gaps in pediatric treatment under the age of 12. This is the same as when the U.S. FDA officially approved Remdesivir in October 2020. The MFDS
- Policy
- PAGs request expedited new drug listing system to candidates
- by Kim, Jung-Ju Jan 10, 2022 05:55am
- With the presidential election two months ahead, patient groups have asked the presidential candidates to introduce an expedited listing system in the National Health Insurance for new drugs directly related to life. On the 7th, the Korea Alliance of Patients' Organizations had set out to propose and deliver ‘4 key patient policies’ fo
- Policy
- Dong-A ST applied for Forxiga's Prodrug license
- by Lee, Tak-Sun Jan 7, 2022 06:06am
- It was found that Dong-A ST applied for permission to the MFDS for Forxiga (Dapagliflozin Propanediol Hydrate, AZ), which has been devoted to development. Dong-A ST succeeded in avoiding material patents (scheduled to expire on April 7, 2023) through prodrug for Forxiga, so there is a possibility that it will dominate the generic market when
