- Policy
- Takeda Obizur accepts results of the drug rating
- by Lee, Tak-Sun Nov 17, 2023 05:59am
- If the alternative drug was accepted less than 90%, the drug price negotiation was omitted. It was confirmed which was conditionally approved by the Pharmaceutical benefit evaluation committee in October, accepted the results and moved to the stage of negotiation. This drug is used to treat bleeding in patients with adult acquired hemoph
- Policy
- Abbvie’s Skyrizi is approved for Crohn's disease in Korea
- by Lee, Hye-Kyung Nov 16, 2023 05:46am
- Abbvie’s ‘Skyrizi,’ which was first introduced to Korea as a psoriasis treatment, has received additional marketing authorization for its Crohn's disease indication The Ministry of Drug and Safety approved Abbvie Korea’s ‘Skyrizi Inj (risankizumab)’ and ‘Skyrizi Cartridge Inj (risankizumab)’ on the 15th. The products, which contain
- Policy
- Chinese immunotherapy tislelizumab to soon arrive in KOR
- by Lee, Hye-Kyung Nov 15, 2023 05:39am
- A PD-1 cancer immunotherapy developed in China is soon expected to receive marketing approval in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety has completed the drug safety and efficacy review for BeiGene Korea’s ‘Tevimbra 100mg (tislelizumab).’ If no issues were found during the safety and effi
- Policy
- Drug price lawsuit recovery & refund, effective on the 20th
- by Lee, Jeong-Hwan Nov 15, 2023 05:39am
- Pharmaceutical company to reduce drug price, abusing lawsuit to reduce 'term profit' strategy In order to recover or refund the loss of drug costs as a result of the drug price-down lawsuit, the NHIS must notify the pharmaceutical company of the details such as the amount of refund, method, and the deadline for submitting opinions. The C
- Policy
- Enforcement rules for the recovery of drug price
- by Lee, Jeong-Hwan Nov 14, 2023 05:49am
- The amendment to the enforcement rules of the 'Refund and Refund Act', which was legislatively announced by the Ministry of Health and Welfare, was judged to be important in the preliminary review of the Regulatory Reform Commission, leaving only the procedure for confirming the enforcement rules as announced in the near future. According to
- Policy
- Discussions on external drug price referencing reevals begin
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- The National Health Insurance Review and Assessment Service will start collecting industry opinions for the external pricing reference system reevaluations next year. At the first meeting, the pharmaceutical industry is said to have expressed disapproval, complaining of fatigue accumulated from successive reevaluations. At the meetin
- Policy
- Drug pricing adjustment guidelines to be established soon
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- With the rise of drugs that show unstable supply and the consequent rise in drugs requesting pricing adjustments, the National Health Insurance Service plans to establish a guideline for smooth pricing adjustment negotiations and disclose it soon. The NHIS recently completed expert consultations and is currently revising the final draft.
- Policy
- Regeneron enters Phase 3 in Korea
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- FDA and EMA review begins in the second half of this year for CD20 and CD3 targeted treatments. Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea. The Ministry of Food and Drug Safety recently submitted an application from ICON Clinical Research Korea for the efficacy and safety
- Policy
- Looking at the review date for GIFT No. 1 Lunsumio
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- "The goal of the GIFT program is to shorten the general review period by 25%. The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.” Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug
- Policy
- Korean researchers develop 1st new substance for Alzheimer's
- by Lee, Hye-Kyung Nov 9, 2023 05:43am
- A Korean research team has developed a new substance (ALT001) that promotes mitophagy, and the recycling of damaged mitochondria, and presented a new door to treating Alzheimer's type dementia. The Korea Health Industry Development Institute (President: Soon-Do Cho) announced that a joint research team that consists of Jin-ho Yoon (College of
