- 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
- Company
- KRPIA-MOHW talk negotiation, prioritized lisiting and PVA
- by Eo, Yun-Ho May 29, 2020 06:16am
- “Nothing was clarified, but we could somewhat feel out their approach.” For the first time since new Director Yang Yoon Seok was appointed, the Division of Pharmaceutical Benefits at Ministry of Health and Welfare (MOHW) met with a couple of dozen Korean Research-based Pharmaceutical Industry Association (KRPIA) officials and multination
- 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
- Product
- Metformin's alternative medicine sold out in an hour
- by Kim JiEun May 29, 2020 06:16am
- As the discontinuation of sales of 31 items of Metformin used as a treatment for type II diabetes patients is decided, the shortage of alternative products is intensifying. The MFDS announced that it will temporarily manufacture, sell, and discontinue prescriptions for 31 items containing Metformin, which are used as a primary treatment for t
- 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
- InterView
- From accountant to BUD, a leadership from diverse experience
- by Eo, Yun-Ho May 28, 2020 10:08am
- When seeking for the right people to work with, companies require the qualities of being both outstanding in one specific area and competent in various areas. And as a next step, companies provide diverse experience to a competent employee in specific area to train them as a leader to take control over various areas. Such trend has been
- Product
- KDA “Agree with government action on metformin with NDMA”
- by An, Kyung-Jin May 28, 2020 10:07am
- Medical academic societies expressed their support for the Korean government’s decision to suspend manufacturing and sales of metformin with excessive level of impurity found. However, the scholars noted diabetic patients should not stop taking metformin without consulting their doctors. On May 26, Korean Diabetes Association (KDA) and Kore
- Company
- Alvogen Korea secures domestic rights for Evista
- by An, Kyung-Jin May 28, 2020 10:06am
- Alvogen Korea took over the domestic rights of 'Evista', an osteoporosis treatment for Takeda. Alvogen Korea announced on the 26th that it had obtained domestic permission for the osteoporosis treatment drug, Evista ( Raloxifene ) from Takeda Pharmaceuticals on the 25th. Evista is a second-generation estrogen receptor modulator (SERM)
- 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
