- Policy
- 22nd new homegrown drug Acelex adds side effect after PMS
- by Lee, Hye-Kyung May 31, 2022 06:06am
- Crystal Genomics’ ‘Acelex Tab (polmacoxib)’ that was approved as the 22nd homegrown new drug in Korea will be adding ‘strokes, etc’ to its list of adverse events. The Ministry of Food and Drug Safety announced that it had completed the opinion review for the Change in Acelex's Indications based on Reevaluation Results (draft) and wil
- Policy
- President Visited KDCA to Strengthen Bio-Health Investment
- by Lee, Hye-Kyung May 31, 2022 06:05am
- President Yoon Seok-yeol visited the KDCA in Osong at 2 p.m. today (26th) to emphasize strengthening investment in key infrastructure in the bio-health industry. On this day, President Yoon discussed with experts how to promote scientific quarantine to prepare for the COVID-19 re-pandemic in autumn and winter at the KDCA Emergency Situation C
- Policy
- Will Dukarb Plus next month rise as Boryung’s savior?
- by Lee, Tak-Sun May 30, 2022 05:42am
- A product that uses the antihypertensive ingredient fimasartan (Kanarb) that Boryung Pharmaceutical developed will be released next month. The product, Dukarb Plus, is a fixed 3-drug combination of fimasartan, amlodipine, and hydrochlorothiazide. Dukarb Plus will be listed for insurance benefit as of June 1st. The release of Dukarb Plus
- Policy
- Chong Kun Dang faces Hanmi due to Rivaroxaban 2.5mg
- by Lee, Tak-Sun May 29, 2022 05:14pm
- Chong Kun Dang anticoagulant Rivaroxaban 2.5mg will be listed as the second generic drug after Hanmi. Since Chong Kun Dang has shown extraordinary affection for anti-coagulation oral new drugs, it is expected that it will also focus its efforts on low dose Rivaroxaban products. According to the industry on the 22nd, Riroxia capsules 2.5mg
- Policy
- Xarelto's generic 15 items have been revoked
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS canceled the item license of Rivaroxaban-based products, which were sold before the expiration date of the registered patent right as of the 27th. The cancelled product is Rixa 10mg, 15mg, 20mg, Wirelto 10mg, 15mg, 20mg, Jabaroxa 10mg, 15mg, 20mg Xarel-Q 10mg, 15mg, 20mg Xarelivan 10mg, 15mg, 20mg. The composition patent of the origi
- Policy
- GSK meningococcal vaccine Bexero PFS was approved in Korea
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS recently approved the item permission of Bexero PFS applied by GlaxoSmithKline (GSK). Bexero PFS is used to prevent invasive meningitis disease by Neisseria meningitidis B group at least 2 months of age. The safety and effectiveness of this vaccine in infants under 8 weeks of age have not been established. This vaccine injects dee
- Policy
- Atopic Dupixent Pen will be available in Korea
- by Lee, Hye-Kyung May 24, 2022 05:54am
- Dupixent, an atopic treatment that is expected to improve convenience when self-injecting at home with easy operation, will be available in Korea. The MFDS recently approved 200mg and 300mg of Dupixent PF Pen applied by Sanofi Aventis. Dupixent PF Pen formulation, which was approved by the U.S. FDA in June 2020, secured adaptations to atop
- Policy
- Fexclu priced at 90% of the weighted average of K-CAB+PPIs
- by Lee, Tak-Sun May 20, 2022 06:12am
- The price of ‘Fexclu Tab (fexuprazan), the potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease (GERD) treatment developed by Daewoong Pharmaceutical was set at 90% of the weighted average price of the same class drug ‘K-CAB (tegoprazan, HK Inno.N) and PPI (proton-pump inhibitors) drugs. On the 12th, the
- Policy
- The MFDS will gradually disclose the results of GMP survey
- by Lee, Hye-Kyung May 20, 2022 06:11am
- The MFDS has decided to disclose the results of the drug GMP survey on its website in the future. The MFDS has prepared a plan to disclose information on the results of the drug GMP survey based on the discussions discussed through the Public-Private Consultative Body on the Results of the GMP Survey. As a PIC/S member country, the results of
- Policy
- Green light to Sprycel's reimb with indication expansion
- by Lee, Tak-Sun May 20, 2022 06:11am
- The chronic myeloid leukemia treatment ‘Sprycel tab (dasatinib, BMS Korea)’ has received the green light to expand its reimbursement. The Health Insurance Review and Assessment Service announced that it had set the reimbursement standards for Sprycel in pediatric patients with acute lymphoblastic leukemia (ALL) at the 5th Cancer Disease Del
