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2024-11-03 13:15
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Policy
MFDS approves Hemgenix for Hemophilia B in Korea
by
Lee, Hye-Kyung
Sep 19, 2024 05:48am
The Ministry of Food and Drug Safety (MFDS) announced on the 13th that it has approved the orphan drug ¡®Hemgenix Inj (etranacogene dezaparvovec)¡¯ imported by CSL Behring Korea. Hemgenix is used to treat moderate-to-severe hemophilia B (congenital blood clotting factor IX deficiency) in adults without a history of Factor IX inhibitors. T
Policy
Moderna¡¯s COVID-19 vaccine is approved in Korea
by
Lee, Hye-Kyung
Sep 13, 2024 05:50am
A new COVID-19 variant vaccine, which is the only mRNA-based COVID-19 vaccine that will be manufactured domestically (by Samsung Biologics) has been approved in Korea. The Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung&160;Oh) announced on the 11th that it has authorized the manufacturing and sale of ¡®Spikevax JN.1¡¯ that M
Policy
Price of Pristiq original and IMDs cut with generic release
by
Lee, Tak-Sun
Sep 11, 2024 05:54am
The release of generic versions of Pfizer's antidepressant ¡®Pristiq ER Tab,¡¯ has hit not only the sales of the original drug but also the salt-modified version. Korea Pharma launched the first generic version of Pristiq in Korea last month, and the release has also affected the salt-modified drug that was released 4 years ago. Accordi
Policy
MFDS announces EUA application of new COVID-19 vaccine
by
Lee, Hye-Kyung
Sep 9, 2024 05:49am
An emergency use authorization process is in progress for new COVID-19 vaccines so that the disease control authorities can inoculate using the vaccines in October. On the 6th, the Ministry of Food and Drug Safety announced an application for emergency use approval of the ¡®JN.1 variant-response recombinant protein vaccine for the prevent
Policy
COVID-19 drug Paxlovid¡¯s price likely to be based on Japan
by
Lee, Tak-Sun
Sep 6, 2024 05:48am
The insurance ceiling price of Pfizer's COVID-19 drug Paxlovid is likely to be set at around KRW 900,000 in Korea. This is similar to its price in Japan. Japan is said to have the lowest price for Paxlovid among the A8 countries. According to industry sources on the 4th, Paxlovid passed the Drug Reimbursement Evaluation Committee (DREC
Policy
¡®Policy support enabled the prompt approval of Envlo¡¯
by
Lee, Hye-Kyung
Sep 4, 2024 05:49am
The backstory of Daewoong Pharmaceutical's Envlo 0.3mg (enavogliflozin), which is a representative success case of the MFDS¡¯s expedited review process, was introduced recently. The government¡¯s policy support for the commercialization of innovative products was what enabled Envlo¡¯s clinical trial to approval in just 5 years. In general
Policy
Alvogen voluntarily recalls Comtan Tab due to impurities
by
Lee, Hye-Kyung
Sep 3, 2024 05:53am
Single-agent entacapones, which are used for Parkinson's syndrome, are being recalled due to the detection of excess impurities. The issue of drug impurities continues to arise after MFDS has added nitrosamine impurity testing as a quality control test item to strengthen the management of nitrosamine impurities. On March 30, MFDS ann
Policy
Prolia¡¯s drug price cut 30% before the entry of biosimilars
by
Lee, Tak-Sun
Sep 3, 2024 05:53am
Prolia, the No. 1 product in the domestic osteoporosis treatment market, has had its upper insurance price limit adjusted this month through price-volume agreement (PVA) negotiations. The drug underwent 4 PVA negotiations in total, which led to a price drop of nearly 30% from the initial price it received in October 2017 upon reimbursement.
Policy
Rival party heads discuss pending issue in NA
by
Lee, Jeong-Hwan
Sep 3, 2024 05:53am
Dong-hoon Han, Chairman of the People Power Party, and Jae-Myung Lee, Chairman of the Democratic Party of Korea met at the National Assembly on the afternoon of the 1st and reached a consensus on resolving the parliamentary conflicts and medical gap. Han mentioned the need to resolve the public's anxiety over the medical gap, while Lee sugge
Policy
Usage recommendations for 3 JAK inhibitors to be changed
by
Lee, Tak-Sun
Sep 3, 2024 05:53am
The Ministry of Food and Drug Safety (MFDS) will implement changes to approval for Janus Kinase (JAK) inhibitors, recommending low dosages when used to treat high-risk patients. This is a follow-up measure to the changes to the efficacy and effectiveness section for high-risk patient treatment in 2022. On August 30th, the MFDS posted
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