- Company
- Kisqali to be listed November starting three-way competition
- by Eo, Yun-Ho Oct 22, 2020 06:32am
- The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor market is expanded to a three-way competition. A pharmaceutical industry source reported, Novartis’ hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer treatment Kisqali (ribociclib) has concluded the pricing negotiation with Nati
- Policy
- Eplerenone was first approved in Korea
- by Lee, Tak-Sun Oct 22, 2020 06:31am
- The drug for hypertension and chronic renal failure, which was not introduced in Korea, was first approved by a small and medium-sized pharmaceutical company in Korea. The MFDS approved a drug for data-based re-evaluation of two doses of Theragen Etex's Eplerenone formulation on the 21st. Eplerenone is generic for Inspra, which was app
- Company
- Samsung-AZ joint venture contemplates on Mabthera biosimilar
- by Kim, Jin-Gu Oct 22, 2020 06:30am
- A subsidiary of Samsung Biologics, Archigen Biotech (“Archigen”) has successfully completed clinical trials but it has not yet disclosed its further plan on the product in development. While Archigen’s sole portfolio is a Mabthera (rituximab) biosimilar in development, the industry is paying attention to the correlation between Archi
- Policy
- Competition for generics for Tenelia M SR is fierce
- by Lee, Tak-Sun Oct 21, 2020 06:35am
- Following Handok's DPP-4 inhibitory diabetes treatment 'Tenelia', the generics for 'Tenelia M SR', a combination drug combined with Metformin, are also actively developing commercialization. According to the MFDS on the 20th, this year, Kyung Dong and Kolmar Korea were approved for a phase I clinical trial to compare the equivalence of th
- Opinion
- [Reporter’s View] Investors’ money, who is it for?
- by An, Kyung-Jin Oct 21, 2020 06:33am
- The public is giving the cold shoulder to the South Korean bio companies and their recent investments. A number of bio companies have apparently invested in Optimus fund that caused loss of about 500 billion won from an alleged fraud. And as the public found out about the fraud, the bio companies could not avoid their harsh reproach. Onc
- Policy
- Sneak peek into NHIS-HIRA audit centering new drug coverage
- by Lee, Jeong-Hwan Oct 21, 2020 06:32am
- The National Assembly annual audit for National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) scheduled on Oct. 20 is predicted to address the issue of improving patients’ coverage on new drugs like high-cost anticancer treatment. The lawmakers would likely to talk about the necessity of legis
- Policy
- MFDS evaluates documents for prolonged COVID-19 crisis
- by Lee, Tak-Sun Oct 21, 2020 06:32am
- The MFDS decided to skip the pre-GMP survey of imported drugs due to the prolonged COVID-19, and to evaluate the documents without exception. The MFDS postponed the survey after the massive outbreak of COVID-19 in February, and document evaluation was conducted for some items without the survey. However, as COVID-19 situation is prolonged
- Opinion
- [Reporter's View] Generic substitution is necessary
- by Lee, Hye-Kyung Oct 21, 2020 06:32am
- The activation of generic substitution was a daily issue at the National Assembly Health and Welfare Committee's national audit held on the 7th to 8th and 13th. It has been a long time since 2015 that the National Assembly has been interested in revitalizing alternative preparations as much as this year. This is also the reason why Young-Seo
- Policy
- The intervention in COVID-19 patents should be cautious
- by Lee, Jeong-Hwan Oct 20, 2020 09:16am
- The MOHW said that the government's intervention in a patent related to a vaccine and treatment for COVID-19 developed with public funds from the government should be carefully reviewed. Requesting nation share in patent rights or property rights of private companies just because vaccines and treatments were developed with government fund
- Policy
- Government unconvinced of pre-listing reimbursement
- by Kim, Jung-Ju Oct 20, 2020 09:16am
- The South Korean government has technically expressed its opposing stance at a National Assembly audit session questioning about the necessity of adopting the ‘pre-listing reimbursement and post-evaluation system’ that exempts a deliberation on reimbursement feasibility to enhance a severe-case patient’s treatment access. Considering
