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2024-12-13 02:36
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Policy
MFDS to review side effects relief imposed on companies
by
Lee, Jeong-Hwan
Aug 28, 2024 05:52am
The Ministry of Food and Drug Safety (MFDS) announced that it would try to set the reasonably sized 'Payment for Benefits for relief of Injury from Side Effects of Drugs, (hereafter referred to as payment for benefits for relief) ' which is currently charged to pharmaceutical companies. MFDS' audit of the Korea Institute of Drug Safety
Policy
SK Chemicals strengthens migraine drug lineup with Suvexx
by
Lee, Tak-Sun
Aug 27, 2024 05:50am
Suvexx, a combination migraine treatment imported and supplied by SK Chemicals, will be reimbursed in Korea next month. Suvexx is a combination of sumatriptan, a triptan-class drug most commonly used for migraine, and naproxen, a non-steroidal anti-inflammatory drug (NSAID). According to industry sources on the 26th, Suvexx will be lis
Policy
Eliquis generics re-enter the market, 35 reimbursed drugs
by
Lee, Tak-Sun
Aug 26, 2024 05:46am
Drugs that are generic versions of the coagulant agent Eliquis (apixaban) will re-enter the market three and five months after discontinuing sales due to a failing patent nullification challenge. It is because the original drug's substance patent is set to expire on September 9th. According to sources on August 23rd, generics containi
Policy
Hanmi faces competition from cheaper Zytiga generic drug
by
Lee, Tak-Sun
Aug 26, 2024 05:45am
A new competing drug has entered the 'Zytiga' generic market, where Hanmi Pharmaceutical was the only company to launch a product last year. Ace Pharmaceutical has introduced a drug imported from India to the South Korean market. While Hanmi Pharmaceutical is strengthening its market presence by recently launching a combination drug
Policy
DREC to review the COVID-19 drug Paxlovid a week earlier
by
Lee, Tak-Sun
Aug 23, 2024 06:17am
The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) will convene a week earlier than scheduled. The DREC review evaluates the appropriateness of new drugs for reimbursement. Industry analysis suggests that the schedule has changed to quickly list the COVID-19 treatment 'Paxlovid
Policy
Ildong to continue oral 'GLP-1 receptor agonist' trial
by
Lee, Hye-Kyung
Aug 22, 2024 05:55am
Ildong Pharmaceutical will conduct an additional round of Phase 1 clinical trial for its proprietary new drug candidate, 'ID110521156,' for the treatment of type 2 diabetes. The drug, by the development code ID110521156, is an oral new drug targeting type 2 diabetes and obesity. On August 20th, the Ministry of Food and Drug Safety (
Policy
Preferential pricing delayed for homegrown new drugs
by
Lee, Tak-Sun
Aug 22, 2024 05:50am
The delay in issuance of a revised draft that includes preferential drug pricing measures for domestic new drugs is raising concerns in the pharmaceutical industry. This month, a revised draft that reflects the innovative value of new drugs was released by the Health Insurance Review and Assessment Service, but the revision lacked a measu
Policy
Takeda receives P3T approval for TAK-861 in Korea
by
Lee, Hye-Kyung
Aug 21, 2024 05:48am
The Japanese pharmaceutical company Takeda Pharmaceuticals will enter Phase III clinical trials for TAK-861, its new drug candidate for narcolepsy, in Korea. On the 20th, the Ministry of Food and Drug Safety (MFDS) on Tuesday approved a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safe
Policy
Orphan drug 'Jaypirca' for Mantle Cell Lymphoma wins nod
by
Lee, Hye-Kyung
Aug 21, 2024 05:47am
The BTK inhibitor Jaypirca (pirtobrutinib) has been approved in South Korea. The Ministry of Food and Drug Safety (MFDS) announced on August 19th that it approved Jaypirca, an orphan drug for treating Mantle Cell Lymphoma (MCL). Lilly Korea imports the drug. Jaypirca works by binding with Bruton's tyrosine kinase (BTK), which is involv
Policy
Reevaluation of foreign drug price comparisons
by
Lee, Tak-Sun
Aug 21, 2024 05:47am
The Health Insurance Review and Assessment Service (HIRA) announced that drug prices will be adjusted in the second half of next year by reevaluating foreign drug price comparisons. This year, an announcement about reevaluation will be made, and the HIRA will conduct the evaluation in the first half of next year. On August 20th, Pre
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