- Company
- Price nego for reimb of much-petitioned Enhertu complete
- by Eo, Yun-Ho Mar 18, 2024 05:49am
- The long journey of the petitioned anticancer drug ‘Enhertu’ if finally coming to an end. According to Dailypharm’s coverage, Daiichi Sankyo and AstraZeneca Korea recently completed drug pricing negotiations with the National Health Insurance Service (NHIS) for their antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhe
- Company
- Hanmi’s Rolvedon tops KRW 73 bil in US sales
- by Son, Hyung-Min Mar 15, 2024 05:49am
- The U.S. sales of Rolvedon (Korean product name: Rolontis), a treatment for neutropenia discovered by Hanmi Pharmaceutical, surpassed KRW 70 billion last year. Assertio plans to conduct additional clinical trials and demonstrate a competitive edge. According to the reports by Assertio on the 13th, Rolvedon generated $11 million in Q4 sal
- 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
- Company
- Sam Chun Dang seeks EMA approval for its Eylea biosimilar
- by Nho, Byung Chul Mar 15, 2024 05:48am
- Sam Chun Dang Pharm announced today that its European partner has simultaneously filed for approval of both vial and prefilled syringe formulations of its Eylea biosimilar (SCD411) in Europe. The application is notable as it is the first application filed in Europe following Korea for the prefilled syringe formulation. The application w
- InterView
- “Solid position of JAK inhibitors despite ongoing concerns"
- by Eo, Yun-Ho Mar 15, 2024 05:48am
- JAK inhibitors, an 'oral drug' that initially gained attention in the field of autoimmune diseases, are now considered one of the treatment options. The first approved ‘Xeljanz (tofacitinib)’ has accumulated a ten-year prescription record. The fifth JAK inhibitor, ‘Jyseleca (filgotinib),’ is now available on the reimbursement listin
- 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
- Company
- Yuhan’s external investments totaled KRW 85 bil last year
- by Chon, Seung-Hyun Mar 14, 2024 05:42am
- Yuhan spent a total of KRW 85 billion in external investments. By acquiring equity investments in companies across various sectors, such as biotech venture and health-functional food, Yuhan scouted for additional acquisitions to expand its business areas. According to the Financial Supervisory Service on the 12th, Yuhan made ten external inve
- 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
