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2025-05-01 13:52
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Policy
Legislation of ¡®INN prescriptions¡¯ for drugs begin
by
Lee, Jeong-Hwan
Dec 4, 2024 05:56am
The government is promoting legislation to recommend international non-proprietary name prescriptions for national essential medicines and drugs with unstable supply and demand and to encourage the use of 'product name and the international non-proprietary name¡¯ when obtaining a marketing authorization. The bill also includes a provision
Policy
17 drugs receive essential medicine designations
by
Lee, Hye-Kyung
Dec 3, 2024 05:53am
Seventeen medicines that are essential for pediatric patients, cancer patients, and others, but require government support due to unstable supply, have been newly designated as national essential medicines. The Ministry of Food and Drug Safety (MFDS, Yu-Kyung Oh) announced on the 29th that it held a meeting on the stable supply of national es
Policy
Janssen¡¯s Tremfya¡¯s price cut 2yrs due to increased use
by
Lee, Tak-Sun
Dec 3, 2024 05:52am
The upper limit price of Tremfya, Janssen's autoimmune disease treatment, is expected to be reduced under the price-volume agreement system for the second consecutive year.&160; According to industry sources, the National Health Insurance Service and Janssen recently finalized PVA negotiations for the reimbursement of Tremfya on the 1s
Policy
Concerns about National Bio Committee's foreign pharma exec
by
Lee, Jeong-Hwan
Nov 29, 2024 05:54am
The National Bio Committee, chaired by President Yoon Suk Yeol, is set to launch in December. However, reports indicate that a global pharmaceutical company executive has been included as a committee member, raising concerns. The committee comprises up to 40 members, including the chair, vice-chair, various ministers, and officials from t
Policy
KIPO opposes to objections to new drug patent extended cap
by
Lee, Jeong-Hwan
Nov 28, 2024 05:55am
The Korea Research-based Pharma Industry Association (KRPIA) and others have submitted an opinion disagreeing with the proposed legislation that would introduce a maximum cap for terms of patent protection for new drugs. The proposed legislation is intended to facilitate an earlier market launch for Korea-made new drugs. The Korean Intellect
Policy
Trial for targeted drug 'VERT-002' for NSCLC begins in KOR
by
Lee, Hye-Kyung
Nov 28, 2024 05:55am
A clinical trial of 'VERT-002,' an innovative targeted treatment for degrading a c-MET gene, will begin in South Korea. C-MET gene is known as one of the cancer-inducing factors of non-small cell lung cancer (NSCLC). On November 27, the Ministry of Food and Drug Safety (MFDS) has granted approval of 'a first-in-human (FIH) multi-center, do
Policy
Handok¡¯s thrombocytopenia drug Doptelet approved in KOR
by
Lee, Hye-Kyung
Nov 28, 2024 05:54am
Handok's new rare disease drug ¡®Doptelet (avatrombopag)' was approved in Korea on the 26th. The Ministry of Food and Drug Safety approved Doptelet as a treatment for thrombocytopenia for patients with liver disease. Handok is reaping the benefits of forging a strategic partnership with the global biopharmaceutical company Sobi-Handok
Policy
Lagevrio prescription age raised from 60 to 70
by
Kang, Shin-Kook
Nov 28, 2024 05:54am
The prescription age for the government-supplied COVID-19 treatment, Lagevrio, will be raised from 60 to 70 from the 27th.&160; According to the Korea Disease Control and Prevention Agency (KCDA), the three COVID-19 drugs (Paxlovid, Lagevrio, Veklury Inj) that were initially supplied by the government, were planned to be included in Korea¡¯s
Policy
Limiting new drug patent term extensions would be beneficial
by
Lee, Jeong-Hwan
Nov 25, 2024 05:53am
The domestic pharmaceutical industry's attention is focused on whether the proposed amendment to the Patent Act, which would limit the drug patent term to 14 years and stipulate the number of patent rights that can be extended to one (singular), will pass the Bill Review Subcommittee of the National Assembly's Standing Committee review.
Policy
Once-weekly Icodec nears approval in Korea
by
Lee, Hye-Kyung
Nov 25, 2024 05:53am
A once-weekly insulin drug for diabetics is close to being approved in Korea.&160; According to the minutes of the Central Pharmaceutical Affairs Council meeting released by the Ministry of Food and Drug Safety (MFDS) on the 21st, the safety and efficacy feasibility of the basal insulin preparation was discussed. As a result of the delib
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