- Policy
- Roche approved to release a new drug treating lymphoma
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- A new drug by Roche, Polivy injection (polatuzumab vedotin), is released to the South Korean market to treat patients with lymphoma, a type of blood cancer. The injection, used in combination with bendamustine and rituximab, is expected to be a new option for patients not responsive to the existing treatment. On Oct. 27, the Ministry
- Policy
- Can the ICER value increase the range of GDP?
- by Kim, Jung-Ju Oct 30, 2020 05:55am
- The National Assembly is calling for an increase in the incremental cost effectiveness ratio (ICER), which is used as the basis for price determination, for reimbursement of expensive drugs, which is the key to strengthening the coverage of Moon Jae In Care pharmaceutical sector. This is because the price of breakthrough new drugs used for se
- Policy
- Pantoprazole, shouldn’t be exceed 20mg per day
- by Lee, Tak-Sun Oct 29, 2020 05:52am
- For Pantoprazole, one of the anti-ulcer PPI, the MFDS is pursuing a change in the approval so that it does not exceed 20 mg per day for patients with severe hepatic impairment. Previously, it was supposed to take 40mg once every other day, but it was not to exceed 20mg per day. The MFDS recently prepared a proposal for amendment of the
- Policy
- The MFDS begins preliminary screening for COVID-19 vaccine
- by Lee, Tak-Sun Oct 29, 2020 05:52am
- It was revealed that the domestic health authorities have begun a preliminary review of the COVID-19 vaccine that AstraZeneca is developing. It is explained that applications for domestic approval are expected after three months as soon as possible. Among vaccines currently being developed at home and abroad, it is the fastest for domesti
- Policy
- Godex continues to monopolize the market
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Celltrion's liver disease treatment 'Godex capsule', which has grown to about &8361;60 billion per year, was developed as tablet formulations rather than conventional capsule formulations and is pursuing product approval. Godex capsule has no competing generics, but as the patent expired in November last year. Accordingly, Celltrion has
- Policy
- Kyongbo joins Galvus latecomer competition with IMD
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Kyongbo Pharmaceutical joined the competition among the dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) latecomers. The South Korean company has reportedly applied for the authority’s approval on its new incrementally modified drug (IMD). According to the Ministry of Food and Drug Safety (MFDS) and the pharmaceutical indu
- Policy
- Continued administration of Remdesivir was recommended
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Domestic health authorities recommended that patients continue to administer 'Remdesivir', a treatment for COVID-19. Although the WHO announced that it was not effective, it was not the final clinical trial result, and the US clinical trial reliability, which was the basis for the approval, was highly regarded. The MFDS and the Korea Dise
- Policy
- Stribild was withdrawn in Korea
- by Lee, Tak-Sun Oct 26, 2020 06:15am
- Stribild, which once ran the No. 1 HIV treatment market with an annual sales of &8361;20 billion, withdrew from the domestic market. It has been 7 years and 8 months since the approval in February 2013. Stribild has been on a roll as a drug that enhances the convenience of AIDS patients by containing four ingredients in one pill, but it
- Policy
- Tagrisso is not an expensive drug
- by Kim, Jung-Ju Oct 26, 2020 06:15am
- While Tagrisso, a new lung cancer drug, is currently being paid for as a second-line treatment, the government responded that it was difficult to claim that it should further increase its coverage as a first-line treatment. This is because the government should apply the principle by reasonably setting the economic evaluation and ICER sta
- Policy
- Hanmi’s generic for Galvus is aiming for release next year
- by Lee, Tak-Sun Oct 23, 2020 09:44am
- Hanmi applied for item approval again three months after withdrawal of the DPP-4 inhibitory diabetes treatment 'Galvus' (Novartis, Vildagliptin) salt-modifying drug. Indications were not removed unlike existing products, and combination drugs were applied for permission. According to the MFDS and pharmaceutical industry on the 21st, Ha
