- Policy
- Ninlaro for multiple myeloma & Lutathera are listed
- by Lee, Hye-Kyung Feb 22, 2021 06:17am
- The standard of benefit of Ninlaro (Ixazomib Citrate), combination therapy for multiple myeloma and Lutathera (Lutetium Oxodotreotide) for neuroendocrine cancer will be established. The HIRA announced that it is proceeding with the amendment of the announcement according to drugs prescribed and administered to cancer patients and will rec
- Policy
- AstraZeneca's vaccine, lot release for 780,000 people
- by Lee, Tak-Sun Feb 22, 2021 06:17am
- All administrative procedures for AstraZeneca's COVID-19 vaccine, scheduled for vaccination on the 26th, have been completed. The final step was approved by the MFDS. The MFDS announced that it had national lot release of 787,000 people (1,574,000 doses) of AstraZeneca's COVID-19 vaccine applied on the 29th of last month on Wednesday.
- Company
- Talks on expanding coverage on Tecentriq to start soon
- by Eo, Yun-Ho Feb 19, 2021 06:17am
- An immunotherapy Tecentriq (atezolizumab) is to face the first threshold to expand the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer D
- Policy
- Atozet’s generics are approved
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- Generics for Atozet (Ezetimibe/Atorvastatin, MSD Korea) were approved on the 18th. Dongkoo Bio, which had joined the Chong Kun Dang group, was also approved. It is reported that Dongkoo Bio transferred and acquired the existing licensed items and newly licensed generic for Atozet according to the license regulations. On the 18th, the MFDS
- Company
- Meditoxin and Innotox back for sales, but what about safety?
- by Feb 19, 2021 06:17am
- Although the Ministry of Food and Drug Safety (MFDS) ordered a license revocation on Medytox’ botulinum toxin drugs, they would be back on the shelf and available for sales as the court halts the administrative action. The relevant industry insiders are pointing out MFDS should be more thorough with pre-sales lot release approval for the pe
- Policy
- Korean-made COVID-19 treatment Rekirona distributed
- by Kim, Jung-Ju Feb 19, 2021 06:17am
- Celltrion has started supplying the first South Korean-made COVID-19 monoclonal antibody treatment Rekirona to healthcare institutes from Feb. 17. Rekirona is a first COVID-19 antibody treatment developed and manufactured in South Korea and it was approved by the Ministry of Food and Drug Safety (MFDS) with condition to further submit cli
- Policy
- The first generic of birth control pills Yaz is released
- by Lee, Tak-Sun Feb 19, 2021 06:17am
- The first generic for Yaz, a pre-contraceptive drug that has established itself in the market, and Duowell’s generic, a combination drug for hypertension and hyperlipidemia, was released. Generic for Yaz is the first with the same ingredients as the original, but in the case of Duowell’s generics, the same ingredient formulations are alr
- Policy
- AZ vaccine for 780,000 people will be inoculated
- by Lee, Tak-Sun Feb 18, 2021 06:28am
- AstraZeneca's COVID-19 vaccine, which starts vaccination on the 26th, received lot release from the MFDS. As a result, it is delivered from the factory and administered at each inoculation site. The lot-released vaccine is expected to be effective until June, and the KCDA plans to complete the vaccination until May. On the 17th, the MFD
- Company
- 19 Korean companies to challenge Entresto patent
- by Kim, Jin-Gu Feb 18, 2021 06:25am
- A series of South Korean pharmaceutical companies are challenging the patents on Novartis’ heart medicine Entresto (sacubitril, valsartan plus sodium salt hydrate complex). Starting with Elyson Pharm filing a patent trial as a first in last year, 18 other companies expressed their intention to release their generics early. According to
- Company
- SK Bioscience has signed a technology transfer contract
- by Kim, Jin-Gu Feb 18, 2021 06:24am
- SK Bioscience has secured the right to independently produce it in Korea by transferring the technology of Novavax vaccine. SK Bioscience announced on the 16th that it has licensed NVX-CoV2373 and signed a contract with the KCDA to supply 40 million doses of vaccine respectively. SK Bioscience announced on the 16th that it has signed a tec
