- Policy
- Major bills have been piled up
- by Lee, Jeong-Hwan Nov 18, 2021 05:54am
- The National Assembly's Health and Welfare Committee held the first subcommittee on bills on the 23rd and 24th and agreed between the ruling and opposition parties to review the medical law and the Pharmaceutical Affairs Act. The second subcommittee on the bill will be held for two days on the 24th and 25th, and both subcommittees are still
- Product
- Expansion of non-face-to-face tx little by little
- by Nov 18, 2021 05:54am
- Despite opposition from the KMA to expand non-face-to-face treatment using regulatory sandboxes, it is judged that the satisfaction of overseas Koreans is high and it will help resolve medical blind spots. However, concerns about allowing regulatory special cases are also expected to increase, taking advantage of regulatory sandboxes. Mini
- Policy
- Will impurities again in losartan trigger full recalls?
- by Lee, Tak-Sun Nov 17, 2021 05:45am
- Once again, impurity was detected in ‘losartan,’ an ingredient used in hypertension treatments. The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of the
- Company
- Hugel's toxin has been approved for national lot release
- by Nho, Byung Chul Nov 17, 2021 05:44am
- As Hugel recently obtained approval from the Ministry of Food and Drug Safety for three types of botulinum toxin products, administrative measures such as "cancellation of permission" and "suspension of product sales" on the 10th proved once again that there was a difference in legal interpretation of indirect exports, not quality and safe
- Company
- Rinvoq combo rises as optimal option in rheumatoid arthritis
- by Nov 17, 2021 05:44am
- AbbVie’s JAK inhibitor ‘Rinvoq (upadacitinib)’ in combination with MTX was found to improve the clinical remission achievement rate over the TNF-α inhibitor ‘Humira (adalimumab)’ combination therapy in rheumatoid arthritis. The Rinvoq combination therapy achieved a 20% range remission rate in the most commonly used DAS28 index as well
- Company
- Exports of Botulinum drugs to the U.S. doubled
- by Kim, Jin-Gu Nov 17, 2021 05:44am
- The cumulative exports of domestic botulinum toxin drugs amounted to 220 billion won this year, the report showed. Exports to China, which had consistently accounted for a high proportion, have decreased, but exports to the U.S. and other countries have increased. According to the Korea Customs Service on the 15th, the cumulative exports o
- Company
- Celltrion's COVID-19 tx is approved for sale in Europe
- by Chon, Seung-Hyun Nov 17, 2021 05:44am
- Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe. Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19. Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirm
- Policy
- No companies have won suits on Gov's price cut dispositions
- by Lee, Hye-Kyung Nov 16, 2021 05:53am
- The National Health Insurance Service said it needs to be granted the authority to urge or dispose of arrears in order to efficiently collect the losses that were caused by the non-price cuts that occurred during the stay of execution when preparing a bill to recover and refund the drug price cut amount. The NHIS delivered its opinion on modi
- Company
- Drug price negotiations for Xospata began
- by Eo, Yun-Ho Nov 16, 2021 05:53am
- The new leukemia drug Xospata is in the final procedure for insurance benefit registration. According to related industries, Astellas recently entered into drug price negotiations with the NHIS for Xospata(Gilteritinib), a treatment for Acute Myeloid Leukemia (AML). The negotiation deadline is until the 20th of next month. After receiving
- Policy
- Chong Kun Dang is approved for its Jardiance Duo latecomer
- by Lee, Tak-Sun Nov 16, 2021 05:52am
- Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ‘Jardiance Duo (empagliflozin-metformin hydrochloride). In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply f
