- Policy
- Qarziba’s reimb standard has been set before approval
- by Lee, Tak-Sun May 31, 2024 05:51am
- The reimbursement standard has been set for Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,” even though it has not yet received approval from the Ministry of Food and Drug Safety (MFDS). Qarzi
- Policy
- MFDS approves the orphan drug 'Pluvicto' for prostate cancer
- by Lee, Hye-Kyung May 31, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) stated that on May 29th, it has granted approval of the orphan drug 'Pluvicto inj (Lutetium(177Lu) Vipivotide Tetraxetan)' for the treatment of prostate cancer. Pluvicto is imported by Novartis Korea. It is a radioligand therapy comprised of radioisotope Lutetium(177Lu), which binds to prostate
- Policy
- Korea-US gov't pledge to strengthen biohealth cooperation
- by Lee, Jeong-Hwan May 31, 2024 05:51am
- The Korean government has decided to strengthen cooperation with the U.S. Department of Commerce in the field of telemedicine and digital health, including non-face-to-face medical treatment. CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, Teladoc, the No. 1 teleme
- Company
- Delay after delay…When will Phesgo be reimb in Korea?
- by Eo, Yun-Ho May 31, 2024 05:51am
- The biobetter breast cancer treatment ‘Phesgo’ is facing a tough road to insurance coverage in Korea. Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab) that combined ‘Perjeta’ and ‘Herceptin’ has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Commi
- Policy
- Research on reforming post-management of pharmaceuticals
- by Lee, Tak-Sun May 30, 2024 05:50am
- The government has initiated research on developing a comprehensive reform of post-insurance management of pharmaceuticals. This research was part of the 2nd Comprehensive NHI Plan, announced earlier this year. According to industry sources on May 29th, a policy initiative reporting session was held to announce the start of the res
- Opinion
- [Reporter’s View] We don’t know the fate of rivoceranib
- by Kim, Jin-Gu May 30, 2024 05:50am
- On the 17th, The US Food and Drug Administration issued a complete response letter (CRL) for HLB and Chinese Jiangsu Hengrui Pharmaceuticals’ frontline camrelizumab plus rivoceranib as a treatment for those with unresectable or metastatic hepatocellular carcinoma (HCC). Immediately after the news broke, HLB's stock price plummeted. The s
- Company
- Over 50,000 ppl signed 2nd petition for Trodelvy’s reimb
- by Eo, Yun-Ho May 30, 2024 05:50am
- The second petition calling for the insurance reimbursement of the breast cancer drug 'Troldelvy (sacituzumab govitecan-hziy)' has again garnered over 50,000 signatures. This is the second petition filed after the first in January that garnered 50,000 signatures. Patients are growing increasingly desperate, as 3 months have passed with li
- Policy
- MSD discontinues supply of Zostavax in Korea
- by Lee, Hye-Kyung May 30, 2024 05:50am
- MSD Korea has announced that it will discontinue the domestic supply of the shingles vaccine Zostavax in Korea. According to the Ministry of Food and Drug Safety, MSD reported the suspension of Zostavax to the Ministry of Food and Drug Safety on Monday. The last batch is expected to be delivered within September, but the supply period is
- Company
- 11 years since global entry…K-biosimilars
- by Chon, Seung-Hyun May 29, 2024 05:45am
- The biosimilar products developed by Korean companies are actively tapping into the global market. Celltrion received approval for Remsima in Europe in 2013. Since then, Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years. Celltrion secured 11 approvals in Europe and t
- Company
- Six pharmaceutical companies challenge the 'Esgliteo' patent
- by Kim, Jin-Gu May 29, 2024 05:45am
- Generic companies have claimed patent challenges against Boehringer Ingelheim’s combination therapy for diabetes, 'Esgliteo (empagliflozin+linagliptin).' It is the strategy of six companies, including Boryung, to launch their generics early by avoiding or nullifying the patent of this combination therapy, which contains SGLT-2 inhibitor
