- Policy
- Voluntary withdrawal of benefit redemption excluding α-GPC
- by Lee, Hye-Kyung Mar 16, 2021 06:22am
- The redemption of benefits related to the drug-related 'Choline Alfoscerate', a brain function improvement agent, has been extended until April 12th. The NHIS has been negotiating benefits redemption of 230 items from 130 companies including Choline Alfoscerate in accordance with the order of the MOHW on December 14 last year. In addition
- Company
- Takeda to chase Roche in ALK targeted therapy market
- by Mar 16, 2021 06:22am
- The follow-on drug competition within the anaplastic lymphoma kinase (ALK)-positive lung cancer treatment market is intensifying with more competitors joining the race. From next month, Alunbrig (brigatinib), receiving the National Health Insurance (NHI) reimbursement for the first-line therapy for lung cancer, and the market leader Alecen
- Company
- Binex is likely to be removed from the KPBMA member list
- by Nho, Byung Chul Mar 16, 2021 06:22am
- It is observed that Binex, which is suspected of changing the manufacturing of active pharmaceutical ingredients, has a strong expulsion from the KPBMA membership. The KPBMA is expected to hold a meeting of the board of directors on the 16th and refer the agenda on the Binex situation to the ethics committee. In a statement on the 11t
- Policy
- Samsung Bioepis' biosimilar for Avastin was first approved
- by Lee, Tak-Sun Mar 16, 2021 06:21am
- Samsung Bioepis was the first in Korea to be licensed for the anticancer drug biosimilar for Avastin (Bevacizumab, Roche Korea). The MFDS licensed Samsung Bioepis' Onbevezy on the 11th. Onbevezy is a biosimilar for Avastin of Roche Korea. Onbevezy is the only approved biosimilar for Avastin in Korea. Like Avastin, Onbevezy is used for
- Policy
- COVID-19 vaccine vaccination rate has exceeded 64%
- by Kim, Jung-Ju Mar 15, 2021 08:24am
- COVID-19 vaccine vaccination rate has exceeded 60%. As the AstraZeneca vaccine is recommended for those over 65 years of age, the quarantine authorities decided to introduce an additional 7 million doses (for 3.5 million people) from the end of May. Joon-wook Kwon, the 2nd vice-president of Central Disease Control Headquarters, explained t
- Policy
- Cases of Vivozon & Binex need ‘1+3 Regulation Act’
- by Lee, Jeong-Hwan Mar 15, 2021 06:29am
- Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act. As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid. The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses.
- Company
- SGLT-2 inhibitor Jardiance to expand HF indication
- by Eo, Yun-Ho Mar 15, 2021 06:28am
- Following after Forxiga, Jardiance is also preparing to introduce the heart failure indication in South Korea. According to a pharmaceutical industry insider, Boehringer Ingelheim Korea is waiting for the health authority’s review result in its sodium-glucose cotransporter 2 (SGLT-2) inhibitor Jardiance’ request to expand indication in
- Policy
- AZ vaccination recommended for age 65 or older
- by Kim, Jung-Ju Mar 15, 2021 06:28am
- The Vaccination Specialist Committee recommended AstraZeneca COVID-19 vaccination for people 65 years of age or older. Accordingly, the quarantine authorities decided not only to immunize them, but also to immunize patients and workers in nursing hospitals and facilities during this month. The COVID-19 Vaccination Promotion Team (Dire
- Company
- HER2 targeted therapy market exceeds KRW 200 billion
- by An, Kyung-Jin Mar 15, 2021 06:28am
- The South Korean market for targeted therapy prescribed to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer has exceeded 200 billion won in sales last year. Two domestically developed biosimilars increased the market influence and made up for the sale revenue void in the original by the original maker’s follow-on dru
- Policy
- MFDS drug review result to be disclosed within 2 months
- by Lee, Tak-Sun Mar 12, 2021 06:23am
- The pharmaceutical review result for new drug would be disclosed within two months from the completed date. Compared to four months taken at the moment, the information disclosure deadline would be cut by two months. Regardless of the affected company’s request for non-disclosure, the summarized information would be publicly opened to impro
