- Policy
- Domestic approval for Pfizer's Cibinqo (PO) is imminent
- by Lee, Tak-Sun Oct 22, 2021 05:45am
- It was found that the domestic approval for oral atopic dermatitis treatment developed by Pfizer is imminent. This product is a JAK inhibitor in the same family as Xeljanz, which is used as a treatment for rheumatoid arthritis. As JAK inhibitors have recently obtained permission with atopy treatment indications one after another, it remains t
- Policy
- "Annual unused drug returns record ₩2.7 trillion”
- by Lee, Jeong-Hwan Oct 22, 2021 05:45am
- NA member and pharmacist Jung-sook Suh of the People Power Party urged the Ministry of Health and Welfare and the Ministry of Food and Drug Safety to present a specific solution to resolve the long-standing issue of ‘unused surplus inventory of drugs' in pharmacies. Currently, the burden of the unused surplus drugs is solely borne by the
- Policy
- There are expectations & concerns about ordering research
- by Lee, Jeong-Hwan Oct 22, 2021 05:44am
- While the government has ordered a study on preferential treatment for domestic new drugs developed by innovative pharmaceutical companies, domestic pharmaceutical companies with new drug technology are expressing both expectations and concerns at the same time. As the government accepts demands from the pharmaceutical industry and critic
- Policy
- Janssen, granted permission to import advanced bio medicines
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea. Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business. On
- Policy
- Vegzelma is the name of Celltrion's Avastin biosimilar
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Celltrion reported on the 1st that it had submitted an application for approval of the biosimilar "CT-P16" of Avastin (Bevacizumab), Roche's colorectal cancer treatment, to the MFDS and the U.S. FDA. According to the MFDS on the 19th, Celltrion's Avastin biosimilar, which was recently applied for permission, is Vegzelma. This is the fir
- Policy
- The status of clinical trials is reported annually
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- The subject of conditional approval and Priority review will be more clarified, and follow-up management will be strengthened. Previously, conditional approval regulations were in the notice, but it is expected that management and operation will be strengthened, including related contents in the Pharmaceutical Affairs Act, and procedural jus
- Policy
- The gov. begins research on preferential tx
- by Lee, Jeong-Hwan Oct 20, 2021 05:56am
- The MOHW has launched a research service to prepare preferential measures for new drugs developed by innovative pharmaceutical companies in Korea. The policy is to innovate pharmaceutical companies and achieve health insurance fiscal consistency, such as giving incentives when adjusting drug prices and supporting drug prices linked to R&D inv
- Policy
- It will improve side effects caused by non-face-to-face tx
- by Lee, Jeong-Hwan Oct 20, 2021 05:56am
- The National Assembly is trying to solve problems arising from the implementation of non-face-to-face treatment temporarily allowed due to COVID-19 for more than a year and reduce social concerns. Instead of allowing non-face-to-face treatment temporarily and extensively, the ruling party-centered National Assembly officially introduces it a
- Policy
- One-shot treatment Kymriah passed the cancer committee
- by Lee, Hye-Kyung Oct 20, 2021 05:55am
- Kymriah (Tisagenlecleucel) of Novartis Korea, a "one-shot treatment" with an ultra-high cost of 500 million won per dose, passed the Cancer Drugs Benefit Appraisal Committee. At the Cancer Drugs Benefit Appraisal Committee held last month, the gap between health authorities and pharmaceutical companies was barely narrowed at the second Can
- Policy
- What's Kymriah's procedure after passing the Committee?
- by Lee, Hye-Kyung Oct 19, 2021 08:54pm
- It seems that it will take time for the ultra-high-priced one-shot treatment Kymriah (Tisagencleucel) to be registered. In particular, it is because the setting of additional financial sharing conditions for pharmaceutical companies, which was not easy in the Cancer Drugs Benefit Appraisal Committee, may pass the Drug Reimbursement Evaluatio
