- Policy
- Lucentis biosimilars have been applied to the MFDS
- by Lee, Tak-Sun Sep 1, 2021 05:57am
- Along with Chong Kun Dang, Samsung Bioepis also applied for permission to the MFDS for Lucentis biosimilar. Lucentis (Ranibizumab) is a treatment for ophthalmic diseases that treat macular degeneration and various eye damage, and it is a blockbuster with annual global sales reaching ￦4.6 trillion and sales of ￦37 billion in Korea as of l
- Policy
- DREC to include patient and civic groups' recommendations
- by Lee, Hye-Kyung Sep 1, 2021 05:57am
- In addition to experts recommended by consumer groups, experts recommended by patients and civic groups will also be included in the 8th Drug Reimbursement Evaluation Committee (DREC) that will be commissioned next month. Also, detailed guidelines that did not exist before for DREC’s subcommittees were newly established to aid the organi
- Policy
- MFDS requests supplements for porcine islet transplant trial
- by Lee, Tak-Sun Aug 31, 2021 06:14am
- Experts from the Ministry of Food and Drug Safety expressed the opinion that supplementary data is necessary for the clinical trial protocol studying a xenotransplantation product that transplants islet cells isolated from pigs to diabetic patients. With such an opinion issued, it seems that some time would be required before the clinical
- Policy
- There is a need to apply the HPV vaccine NIP Men Under 17
- by Lee, Jeong-Hwan Aug 31, 2021 06:13am
- President Moon promises free vaccination for girls under 12 → girls under 17. In addition, there is a need for free vaccination of male teenagers of the same age group. HPV, which causes cervical cancer, claims that the country needs to expand vaccination because it can infect both men and women through sexual contact and causes various di
- Policy
- Korean pharmas are pursuing various SGLT-2 combos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- Companies are busy developing combination therapies combining the latest diabetes treatment, SGLT-2 inhibitors, with existing diabetes treatment. In particular, domestic companies that are eyeing the SGLT-2 market have been testing various combinations for commercialization. On the 26th, the Ministry of Food and Drug Safety approved the P
- Policy
- The patent for Breast Cancer Therapy Affinitor has been clos
- by Lee, Tak-Sun Aug 30, 2021 05:55am
- The patent suit for Affinitor, which was conducted by Novartis and Kwang Dong, was finally closed due to the plaintiff's withdrawal. As a result, Kwang Dong and Samyang Biopharm are able to market more actively. According to the industry on the 26th, the lawsuit against the use patent of Afinitor, which has been filed since March last year
- Policy
- Regulation of COVID-19 vaccines is imminent
- by Lee, Jeong-Hwan Aug 27, 2021 05:59am
- As the "Special Act on the Development of Public Health Crisis Response Medical Products and the Emergency Supply" sub-enforcement decree passed the Regulation Reform Committee preliminary review, regulations and management such as COVID vaccines will be strengthened. The MFDS plans to conduct a follow-up investigation of the public health
- Policy
- RSA refund should be differentiated by income
- by Kim, Jung-Ju Aug 27, 2021 05:59am
- Currently, it has been suggested that Korea should apply RSA's refund flexibly by differentiating it according to income. It is suggested that the government should reduce the refund of high-income earners according to the income distribution and strengthen the guarantee of high-weakness by operating the refund of low-income earners in the form
- Policy
- Clinical trials of Jardiance have been approved
- by Lee, Tak-Sun Aug 26, 2021 05:58am
- The SGLT-2 diabetes treatment has expanded its indication to other treatments for diseases such as heart failure. In Korea, AstraZeneca's Forxiga (Dapagliflozin Propanediol Hydrate) has also been recognized for its efficacy and effect on chronic heart failure and chronic kidney disease. And Boehringer Ingelheim's "Jardiance (Empagliflozin)" i
- Policy
- Ppl willing to pay max ₩13.52 mil. for one-shot therap
- by Kim, Jung-Ju Aug 26, 2021 05:58am
- Over 75% of the public responded that high-priced innovative new drugs, or so-called ‘one-shot treatments,’ should be covered by the National Health Insurance. As to the maximum price the public was willing to pay for such treatments, the average price was &8361;13.52 million, and the most amount of respondents - 33.3% - agreed to the price.
