- Policy
- MSD withdraws SGLT2 inhibitors in a row
- by Lee, Hye-Kyung Mar 20, 2024 05:44am
- MSD Korea is facing tough competition in the market for SGLT-2 inhibitors in South Korea. MSD decided that they will discontinue the supply of Steglatro Tab 5 mg and 'Stegluzan Tab 5/100 mg (ertugliflozin plus sitagliptin)' after voluntarily withdrawing 'Steglatro Tab 15 mg (ertugliflozin)' and metformin combination therapy, 'Segluromet,' la
- Policy
- President Yoon stands on expanding quota to 2,000
- by Lee, Jeong-Hwan Mar 20, 2024 05:44am
- President Yoon Suk Yeol reaffirmed the government’s plan to increase the medical school enrollment quota to 2,000 and stated, “Korea’s policy related to the number of doctors is not meeting the standards of the current era and actual needs, repeating the history of failure. Doctors’ licenses should not be used as a tool to intimidate K
- Policy
- Essential medical devices will be designated by next year
- by Lee, Hye-Kyung Mar 20, 2024 05:44am
- The Ministry of Food and Drug Safety is considering establishing a system to designate national essential medical devices. More specifically, the government plans to set a specific scope of medical devices that are essential for healthcare, such as rapid antigen test kits and life support devices that were necessary during COVID-19 but were diff
- Policy
- Liver cancer therapy, ‘Stivarga’ set for 2nd RSA renewal
- by Lee, Tak-Sun Mar 19, 2024 05:44am
- It has been reported that a risk sharing agreement (RSA) has been renewed for the second time for Stivarga (regorafenib; Bayer Korea), a second-line treatment for liver cancer. The news comes two months before the reimbursable RSA contract for Stivarga is set to expire on May 31st. According to industry sources on the 18th, the Nationa
- Policy
- Sotyktu, Adtralza set for reimbursement listing
- by Lee, Tak-Sun Mar 18, 2024 05:49am
- Two drugs, plaque psoriasis drug 'Sotyktu (deucravacitinib)' and atopic dermatitis drug 'Adtralza (tralokinumab)' have completed the negotiation with the National Health Insurance Service (NHIS) and may soon be listed for reimbursement. Additionally, the upper price limit of Soliris (eculizumab) is expected to be reduced following the e
- Policy
- Anticipated shortage of Merck’s fertility drug ‘Gonal-F’
- by Lee, Hye-Kyung Mar 15, 2024 05:49am
- The shortage of Merck’s 'Gonal-F Pen,' which is the world’s first recombinant follicle stimulating hormone (r-FSH), is expected. Merck has announced that three, 300/450/900IU, of the four volumes of Gonal-F Pen approved by the Ministry of Food and Drug Safety (MFDS) are expected to be short in supply. Currently, the 150IU volume is in
- Policy
- Gov't will specify scope of expense report details disclosed
- by Lee, Jeong-Hwan Mar 15, 2024 05:49am
- The Ministry of Health and Welfare recently met with physician and pharmacist organizations and the pharmaceutical, biotech, and medical device industries to collect opinions on setting the ‘scope of disclosure of expense reports’ that are prepared to report the expenses legally paid by pharmaceutical and biotech companies and medical de
- Policy
- HIRA’s CDDC seeks to revise current regulations
- by Lee, Tak-Sun Mar 15, 2024 05:48am
- The current regulation that randomly selects members for each Cancer Disease Deliberation Meeting will be deleted. The measure was prepared to maintain consistency in the committee’s deliberations. In addition, the Korean Association for Lung Cancer will be added as a recommended organization given that lung cancer drugs are often on th
- Policy
- MFDS starts regulatory innovation program for Big Techs
- by Lee, Hye-Kyung Mar 14, 2024 05:42am
- The Ministry of Food and Drug Safety (MFDS) announced that will be operating a ' 2024 Big Tech Company Regulatory Innovation Program’ again this year to provide continuous regulatory support to domestic digital medical device companies. Last year, the MFDS identified the exact needs of the industry through the Big Tech Company Regulatory
- Policy
- Chong Kun Dang also enters low-intensity atorvastatin mkt
- by Lee, Hye-Kyung Mar 14, 2024 05:42am
- Amid fierce competition in the hyperlipidemia drug market to develop 2nd generation ‘statin + ezetimibe’ combination drugs using low-strength statins, some low-dose atorvastatin products are also soon to enter the market. On the 12th, the MFDS approved Chong Kun Dang's ‘Lipilou Tab 5mg.’ It is a 5 mg low-strength single tablet that co
