- Policy
- Antiviral Zovirax license transferred from GSK to Ilsung
- by Lee, Tak-Sun Nov 6, 2020 06:26am
- Used for decades in South Korea as an antiviral drug against herpes simplex virus (HSV) and varicella zoster virus (VZV), Zovirax (acyclovir) has completed the local sales rights transfer from GlaxoSmithKline (GSK) to Ilsung Pharmaceuticals An acyclovir original, Zovirax, lost ‘GSK’ from its name as recently GSK voluntarily dropped the
- Policy
- The HIRA is conducting RWE research on cancer & rare dz
- by Lee, Hye-Kyung Nov 4, 2020 06:09am
- The HIRA will be conducting prospective clinical research to secure real world evidence (RWE) for cancer and rare disease treatments in earnest starting next month. From last year to recently, the RWE guidelines were created through retrospective studies, and from this year to 2023,'prospective clinical research to prepare a platform for
- Policy
- New reimbursement standards on Rinvoq and Remicade
- by Kim, Jung-Ju Nov 4, 2020 06:09am
- Starting this month, the drug reimbursement would be granted on AbbVie Korea's rheumatoid arthritis treatment Rinvoq Sustained-release Tablet (upadacitinib) 15mg. As a result, the reimbursement standards have been changed for drugs with other various substances available for a treatment switch, and the combination therapy with the drug would
- Policy
- Hanmi’s generic for Nexavar has been approved
- by Lee, Tak-Sun Nov 4, 2020 06:08am
- Hanmi's generic for Nexavar (Sorafenib, Bayer) was first approved in the liver cancer treatment market. In addition, it acquired exclusive rights in the generic market for nine months after its launch. On the 29th, the MFDS approved Hanmi's Soranib 200mg. Soranib is generic for Nexavar. It is used for hepatocellular carcinoma, advanced
- Policy
- Daewoong's DWP16001 targets synergistic effect with Zemiglo
- by Lee, Tak-Sun Nov 3, 2020 05:58am
- Daewoong's new SGLT-2 inhibitory diabetes drug candidate is aiming for synergy with another domestic drug. The drug, first designated for expedited review, has been approved for three phase III clinical trials. The MFDS approved a phase III clinical trial protocol for Daewoong Pharmaceutical's new diabetes drug candidate 'DWP16001 (Enavog
- Policy
- Merck green lit to test novel COVID-19 antiviral in Korea
- by Lee, Tak-Sun Nov 3, 2020 05:58am
- A novel COVID-19 antiviral candidate, currently in development by a U.S.-based pharmaceutical company Merck, is to conduct a clinical trial in South Korea. Previously, Bloomberg covered the novel candidate as a ‘potential game-changer in the COVID-19 therapeutic scene. On Oct. 29, the Ministry of Food and Drug Safety (MFDS) has appr
- Policy
- 1 out of 4 claims for unltra priced Spinraza were approved
- by Lee, Hye-Kyung Nov 3, 2020 05:58am
- Only one out of four applications for pre-approval for salary medication 'Spinraza (Nusinersen)', a treatment for Spinal Muscular Atropy (SMA), was approved last month. The remaining one can be approved conditionally, and two have to be supplemented with data. A monitoring report must be submitted before administration of maintenance dose
- Policy
- Hyundai is preparing for domestic approval of Mifegyne
- by Lee, Jeong-Hwan Nov 2, 2020 06:13am
- Hyundai Pharm, which maintains the No. 1 market share in the emergency (post) contraceptives market, is preparing for the domestic market approval of the artificial abortion drug Mifegyne. Mifegyne was ruled by the Constitutional Court for an abortion inconsistency in April last year, and the need to legalize domestic use and interest in
- Policy
- Special agreement for re-evaluation of α-GPC is urgent
- by Lee, Jeong-Hwan Nov 2, 2020 06:12am
- Nam In-soon, a member of Democratic Party of Korea, stressed that there is a need for a 'special contract to return the reimbursement price' between the NHIS and pharmaceutical companis that applied for the clinical re-evaluation of Choline alfoscerate. In clinical reevaluation, a pharmaceutical company that failed to prove the usefulness
- Policy
- Vildagliptin generic preferential sales date may get delayed
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- The preferential sales rights Ahn-gook Pharmaceutical has earned for the Galvus (vildagliptin) generic could be cut as a higher court trial has overturned the patent litigation decision. Accordingly, the South Korea’s Ministry of Food and Drug Safety (MFDS) is internally reviewing the matter. On Oct. 29, the Patent Court has partially r
