- Policy
- Gilead starts trial for its autoimmune disease drug in KOR
- by Lee, Hye-Kyung Dec 20, 2024 05:47am
- The B- and T-Lymphocyte Attenuator (BTLA) autoimmune disease treatment will enter clinical trials in Korea. The Ministry of Food and Drug Safety approved Gilead Sciences' application for a ‘multicenter, randomized, placebo-controlled Phase 1b clinical trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and phar
- Policy
- Keytruda’s reimb for gastric cancer will be redeliberated
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- The application to expand the gastric cancer indication for the immuno-oncology drug Keytruda (pembrolizumab, MSD) has been given a ‘redliberation’ decision. The drug is currently seeking reimbursement for 17 indications, but financial issues have prevented a conclusion. The Health Insurance Review and Assessment Service’s Cancer Disea
- Company
- LG Chem wins Zemiglo patent dispute
- by Kim, Jin-Gu Dec 20, 2024 05:46am
- LG Chem has won the 2nd trial of a patent dispute over the use of DPP-4 inhibitor diabetes drug Zemiglo (gemigliptin). The company was able to reverse its first trial loss and won the second trial, enabling it to prevent patent challengers from launching their generic versions early. The pharmaceutical industry's attention has now turn
- Policy
- Basic refund type-drugs granted early RSA termination
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- Only drugs categorized as a basic refund type are possible when a pharmaceutical company wishes to terminate the Risk Sharing Agreement (RSA) early. However, pharmaceuticals on the cost-effectiveness evaluation waiver track, demonstrating cost-effectiveness, can be submitted for negotiation through the renewal of the agreement. The Nati
- Policy
- Cinacalcet impurities spread…Huons recalls product
- by Lee, Hye-Kyung Dec 19, 2024 05:53am
- The detection of excess 'N-nitroso cinacalcet' impurity has led to the recall of the kidney drug cinacalcet hydrochloride. The Ministry of Food and Drug Safety announced on the 17th that Huons’ Calcepara Tab 25 mg (cinacalcet hydrochloride) with 3 manufacturing numbers TTB201 (2025-08-16), TTB301 (2026-05-18), and TTB302 (2026-05-21) will be
- Policy
- Sanofi signs PVA negotiations for hemophilia drug 'Alprolix'
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- The ceiling price for Sanofi's 'Alprolix,' a new treatment for hemophilia B, is expected to decrease through price-volume agreement (PVA) negotiations. This drug was approved in May 2017, and reimbursement listed in June of the following year. According to industry sources on December 18, the National Health Insurance Service (NHIS) a
- Policy
- Hyperphosphatemia treatments undergo generation change
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Drugs that improve hyperphosphatemia in patients with chronic kidney disease are undergoing a generation change in the domestic market. Following the launch of the new drug Nephoxil Cap (ferric citrate, Kyowa Kirin Korea) last year, generic drugs containing sevelamer have continued to grow, and news of the withdrawal of existing drugs is
- Company
- 'Vyloy' to expand treatment options for gastric cancer
- by Whang, byung-woo Dec 19, 2024 05:52am
- Vyloy (active ingredient: zolbetuximab), a Claudin-18.2-targeting gastric cancer therapy, is rising as the new treatment option for stage 4 gastric cancer despite an issue related to companion diagnostics. As the number of newly diagnosed patients with Claudin-18.2 increases in clinical practices, the drug will be more widely used from the e
- Policy
- Prior notification of drug permit changes extended to 2025
- by Lee, Hye-Kyung Dec 19, 2024 05:52am
- The operation of the pilot program, 'Advance Notification System for Drug Change Permit', which allows drug manufacturers and importers to apply for change permits on their preferred date, will be extended. According to industry sources on the 18th, the Ministry of Food and Drug Safety (MFDS) will extend the pilot project until December 31 ne
- Company
- Kuhnil signs licensing agreement with Mochida
- by Whang, byung-woo Dec 18, 2024 05:55am
- Kuhnil Pharm announced on the 16th that it has signed a sales partnership agreement for Epadel, an original version of the highly purified eicosapentaenoic acid (EPA) ethyl ester formulation, with Mochida Pharmaceutical in Japan. Founded in 1913, Mochida Pharmaceuticals is a leading Japanese innovative pharmaceutical company that has play
