- Company
- Korean bio companies intent on developing new AD drugs
- by Son, Hyung-Min Nov 15, 2023 05:39am
- Despite downturns, including the return of the rights for JW Pharmaceutical’s atopic dermatitis drug candidate, clinical trials for new drugs to treat atopic dermatitis are still ongoing in Korea. Last month, JW Pharmaceutical announced that its technology transfer agreement for its atopic dermatitis treatment JW1601 which it signed with the
- 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
- Company
- Will the new ADC breast cancer drug Trodelvy be reimb?
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- ‘Trodelvy,’ another new ADC drug for breast cancer, is seeking reimbursement listing in Korea. According to industry sources, Gilead Science Korea has submitted an application for the reimbursement of its triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan-hziy) on July 31, and the agenda is awaiting to be presented
- 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
- Company
- Market for montelukast revive…overcomes impurity issue
- by Kim, Jin-Gu Nov 14, 2023 05:49am
- The market for asthma treatments containing the ingredient montelukast has succeeded in complete revival. This market shrank significantly in 2020-2021 due to the side effects issue and the COVID-19 outbreak, but made a rebound last year, and is expected to expand to the largest size ever this year. The market which remained stagnant fo
- 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
- Company
- Conquest of low survival gallbladder cancer
- by Nov 14, 2023 05:49am
- In the area of bile duct cancer, where survival rates are low and treatment options are scarce, new drug candidates from domestic pharmaceutical companies have been confirmed in clinical practice and are one step closer to commercialization. HDB001A, a new drug candidate for gallbladder cancer that Handok is developing, has recently been approve
- 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
