- Company
- Expansion of indications for Forxiga as a treatment for HFrE
- by Jung, Sae-Im Jun 23, 2023 05:43am
- AstraZeneca Korea announced on the 22nd that its SGLT-2 inhibitor Forxiga has additionally obtained indications for HFpEF and HFmrEF from the Ministry of Food and Drug Safety. The indication approved this time is to reduce the risk of death due to cardiovascular disease, hospitalization due to heart failure, and urgent hospital visits due to
- Company
- GO for patent litigation, NO for suspension of execution
- by Kim, Jin-Gu Jun 22, 2023 04:14pm
- Janssen Korea has decided not to file a lawsuit for canceling a drug price cut and a request for suspension of execution following the appeal in a patent dispute. It is interpreted as an intention to avoid controversy over the abuse of the suspension system related to the so-called 'Drug Price Reduction and Refund Act' that recently passed the N
- Policy
- Expansion of # of members of the Committee to around 105
- by Lee, Tak-Sun Jun 22, 2023 05:43am
- The number of members of the Pharmaceutical Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service will be expanded from around 100 to around 105. It is a policy to strengthen the expertise in evaluating the adequacy of drug treatment benefits by increasing the number of experts recommended by pharmaceutical
- Company
- Leclaza confirms brain metastasis benefits
- by Hwang, byoung-woo Jun 22, 2023 05:41am
- "I think this is a meaningful study in that the third-generation EGFR TKI treatment, such as Lazertinib, showed data related to brain metastasis, but clearly focused on the intracranial response to confirm the effect." When brain metastasis occurs in non-small cell lung cancer patients using 1st or 2nd generation EGFR TKI agents, most patients'
- Policy
- New drug pre-registration - post-evaluation non-face-to-face
- by Lee, Jeong-Hwan Jun 22, 2023 05:41am
- The government plans to include discussions on the need to apply innovative insurance systems such as new drugs and new medical technology 'seondeungjae-postevaluation' to strengthen treatment coverage for severe diseases such as cancer in the '2nd National Health Insurance Comprehensive Plan' to be established in the second half of this year
- Policy
- MFDS cautious about strengthening regulations
- by Lee, Jeong-Hwan Jun 22, 2023 05:40am
- The Ministry of Food and Drug Safety explained that although the MFDS with the purpose of the legislation to strengthen regulations on drugs that have been conditionally approved for expedited marketing authorizations before completing Phase III clinical trials from the current guideline level to the Pharmaceutical Affairs Act level, its app
- Policy
- Imported orphan drug specimen storage standards
- by Lee, Hye-Kyung Jun 22, 2023 05:40am
- The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) announces a legislative announcement on the 21st of the amendment to the 'Rules on Safety of Pharmaceuticals, Etc. and, comments are accepted until August 21st. The main contents of this revision are ▲ rationalization of sample storage standards for importers of imported orphan dr
- Company
- JAKi Civinqo completes pricing negotiations for reimb in KOR
- by Eo, Yun-Ho Jun 22, 2023 05:40am
- The atopic dermatitis treatment ‘Cibinqo’ may be listed for reimbursement in Korea from July. According to industry sources, Pfizer Korea completed the pricing negotiations for its new JAK1 inhibitor drug Cibinqo (abrocitinib) with the National Health Insurance Service. Drugs that pass the Health Insurance Policy Deliberative Committee (
- Company
- Joint development & production of DM Combi with SK Chem & AZ
- by Kim, Jin-Gu Jun 21, 2023 10:06am
- SK Chemicals plans to supply products developed and produced to 12 global countries through AZ. SK Chemicals announced on the 19th that it has produced the first commercial product of a diabetes complex jointly developed with AstraZeneca. SK Chemicals explained that it recently held an event to inspect and celebrate the global joint busin
- Opinion
- [Reporter’s View] Closer look into Korea’s new drug access
- by Eo, Yun-Ho Jun 21, 2023 05:53am
- “Korea has low new drug access. It needs to be improved.” As much as the phrase comes to heart, we need to look more closely into the matter to correctly assess the situation. Recently, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently published a report on Korea’s current new drug release status based
