- Policy
- The MFDS released a national lot release of Comirnaty
- by Lee, Hye-Kyung Mar 31, 2022 04:29pm
- The MFDS (Director Kim Kang-rip) announced on the 29th that it has released 299,000 doses of Pfizer's Comirnaty 0.1mg/mL (for 5-11 years old) in Korea. The MFDS conducted Comirnaty test and reviewed the manufacturing and test data of the manufacturer, and confirmed the effectiveness, safety, and quality, and decided to release the national
- Policy
- Roche RET target anticancer drug Gavreto, approved in Korea
- by Lee, Hye-Kyung Mar 31, 2022 04:23pm
- Roche's non-small cell lung cancer treatment Gavreto (Pralsetinib)"has obtained an item license in Korea. The MFDS approved Gavreto 100mg on the 29th. The drug was recognized for its effectiveness in the treatment of ▲RET (RET) fusion-positive local progression or metastatic non-small cell lung cancer adult patients and ▲ systemic therap
- Policy
- Reimbursement priorities in ultra-high-priced one-shot Txs
- by Lee, Tak-Sun Mar 31, 2022 05:57am
- With the reimbursement imminent for the ultra-high-priced one-shot treatment Kymriah, the National Health Insurance Service is preparing to conduct research on the performance evaluation of the risk-sharing agreement (RSA) and its mid-to-long-term development direction. The research will be exploring ways on the development direction of
- Policy
- Multidrug-resistant ‘Zavicefta’ applies for approval
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Pfizer Korea has applied for the approval of its important treatment for severe gram-negative bacterial infection, ‘Zavicefta.’ Zavicefta, which received marketing authorization in 2016. is a combination drug that contains the third-generation ceftazidime. According to industry officials on the 28th, Pfizer Korea recently submitted a
- Policy
- Will the migraine tx Reyvow step on the same track
- by Lee, Tak-Sun Mar 29, 2022 05:54am
- Ildong Pharmaceutical's domestic copyrighted migraine drug Lasmiditan seems to be speeding up its benefit using the patent-approval linkage system. According to the industry on the 28th, the HIRA is recently listening to opinions on whether the migraine treatment Reyvow 50 & Reyvow100mg is eligible for medical care benefits through related co
- Policy
- BMS acute myeloid leukemia tx Onureg was approved
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Onureg 200mg and Onureg 300mg, the first PO drugs were approved. Currently, Azacitidine-based AML treatments, which are approved in Korea, are injections with Celgene's Vidaza100mg, Boryung Pharmaceutical's Vizadakin and Samyang Holdings' Azalid 100mg and Azalid 150mg, and Onureg has become the first oral treatment. The MFDS (Director K
- Policy
- Will the separation of the Ministry of Health be promoted?
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- Yoon Seok-yeol's presidential transition committee seems to be discussing the necessity of separating the Ministry of Health and integrating and absorbing the MFDS in the process of discussing the reorganization of the government after the inauguration of the next government. As the pandemic era became commonplace due to COVID-19, the role o
- Policy
- Govn’t to introduce 460,000 courses of oral COVID-19 drugs
- by Kim, Jung-Ju Mar 28, 2022 06:10am
- The government will be introducing 460,000 courses of oral COVID-19 treatments by the end of next month. In principle, Paxlovid will be prescribed first, and Lagevrio, which has recently been approved for emergency use, should be used for patients who are restricted from using Paxlovid, such as users of contraindicated drugs. On the 25th,
- Policy
- The gov's all-out efforts to promote EUA for overseas drugs
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- The government will make all-out efforts to expand the total amount of supply by expanding the production and import of regular medicines such as antipyretic painkillers and cold medicines used to alleviate COVID-19 symptoms. It will even review the emergency introduction of foreign drugs with the same composition as domestic licensed items,
- Policy
- Kymriah's benefit standard has been established
- by Lee, Tak-Sun Mar 25, 2022 05:48am
- Chimeric antigen receptor-T cell therapy, which can be effective only once by using cancer patient T cells, is expected to be given to patients after receiving health insurance benefits for the first time in Korea from April. Novartis' Kymriah will enter the benefit range a year after being approved in Korea. The HIRA announced that it wil
