- Policy
- Mabthera coverage extended and Strensiq newly listed
- by Kim, Jung-Ju Jun 1, 2020 06:20am
- Healthcare reimbursement would be granted on AbbVie Korea’s adult psoriasis treatment Skyrizi prefilled syringe (risankizumab) and Handok’s rare disease treatment Strensiq Injection (asfotase alfa) with new reimbursement standards. Korea’s Ministry of Health and Welfare (MOHW) announced the finalized changes in the revised Healthcare
- Policy
- Hanmi, applied for permission for Xoterna's generic drug
- by Lee, Tak-Sun Jun 1, 2020 06:19am
- Hanmi is expanding its inhaler business for respiratory diseases such as bronchial asthma and chronic obstructive pulmonary disease (COPD). In 2014, Fluterol, generic for GSK's asthma treatment was first introduced in Korea, and recently, the COPD treatment Xoterna (Korea Sandos) is also targeting the market. According to the industry
- Policy
- Novartis filed a lawsuit for Galvus’ salt-altering drug
- by Lee, Tak-Sun May 29, 2020 06:17am
- It was confirmed that Novartis has filed a lawsuit against the MFDS regarding the approval process of 'Vildagle 50mg' (Vildagliptin HCl), a DPP-4 series diabetes treatment drug that was approved in January. Unlike the Novartis’ Galvus (Vildagliptin), Hanmi's Vildagle is a salt-altering drug with HCl. In addition, Vildagle's indication doe
- Policy
- KAPO-HIRA on Lutathera coverage “Shooting for September”
- by Lee, Jeong-Hwan May 29, 2020 06:16am
- A patient group announced a meeting was convened with Health Insurance Review and Assessment Service (HIRA) Pharmaceutical Management Department to talk about granting healthcare reimbursement on Neuro Endocrine Tumor (NET) treatment Lutathera. The group is demanding the Korean government to take into consideration of the patients relucta
- Policy
- A market return track is needed for NDMA-related drugs
- by Lee, Jeong-Hwan May 29, 2020 06:16am
- The production and sales of Valsartan, Ranitidine, and Metformin have been discontinued due to the detection of NDMA (N-nitrosodimethylamine), a carcinogen, and prescriptions have been limited, and people's anxiety and the blow to the pharmaceutical industry are increasing. In particular, while NDMA detected in Valsartan in the past was i
- Policy
- Bayer’s NUBEQA was approved by the MFDS
- by Lee, Tak-Sun May 28, 2020 10:08am
- Another prostate cancer drug, Bayer's Nubeqa, was approved in Korea. On the 27th, the MFDS approved a new drug for Bayer Korea's 'Nubeqa 300mg' (Darolutamide) as a treatment for patients with non-metastatic castration-resistant prostate cancer(nmCRPC). Darolutamide, the active ingredient, is a nonsteroidal antiandrogen (NSAA), and acts as
- Policy
- The MFDS suspends sales of 31 items of Metformin
- by Lee, Tak-Sun May 28, 2020 10:06am
- As the MFDS temporarily suspends manufacturing, selling, and prescribing 31 items containing Metformin, which are being used as the primary treatment for patients with type II diabetes, the issue of impurities in pharmaceuticals is expected to re-occur. However, due to the same NDMA issue, 175 Valsartan products and 269 Ranitidine were di
- Policy
- PVA lowers Entresto and Synovian pricing
- by Kim, Jung-Ju May 27, 2020 06:04am
- The prices of Novartis Korea’s Entresto film-coated tablet (sacubitril plus valsartan plus sodium salt hydrate complex) and LG Chem’s Synovian injection (BDDE bridged sodium hyaluronate gel) have been negotiated to be lowered by 7 percent and 2.7 percent, respectively, due to their increased use. Daewoong Pharmaceutical, Ildong Pharmaceuti
- Policy
- Benefit of COVID-19 medications completed in just one day
- by Lee, Hye-Kyung May 27, 2020 06:04am
- In order to prevent the spread of COVID-19 infection, the HIRA is the one which is drawing attention. The DUR system was used to help medical institutions check immigration visit information from around the world, and it shortened the review period for drug benefit standards that took more than 80 days on average to one day, promptly res
- Policy
- Ultomiris, a successor to Soliris, was approved in Korea
- by Lee, Tak-Sun May 27, 2020 06:04am
- Handok acquired a domestic item license for paroxysmal nocturnal hemoglobinuria (PNH) treatment 'Ultomiris'. Ultomiris is a product that was expected as a successor to Soliris, and is a drug developed by Alexion, like Soliris. In particular, it has attracted attention in that it has increased convenience by significantly reducing the numbe
