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2025-07-07 09:20
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Policy
Boryung's follow-on Lenvima, 'Lenvanib,' becomes reimbursed
by
Lee, Tak-Sun
Jul 7, 2025 06:09am
Boryung has successfully obtained reimbursement listing for all dosages of 'Lenvanib Cap (lenvatinib mesylate dimethyl sulfoxide),' its follow-on drug to the anti-cancer medication Lenvima (lenvatinib mesylate, Eisai), which is used to treat conditions such as liver cancer. With the patent dispute with the original manufacturer, Eisai, sti
Policy
MFDS reviews GMP standards for sterile preparations abroad
by
Lee, Hye-Kyung
Jul 7, 2025 06:09am
With the Ministry of Food and Drug Safety planning to enforce revised GMP standards for sterile drug products reflecting PIC/S international standards in December, it plans to identify research tasks on items that require international harmonization by analyzing the regulatory status of reference countries. Ahead of its re-entry into PIC/S in
Policy
MFDS reviews emergency import of 'anakinra'
by
Lee, Hye-Kyung
Jul 7, 2025 06:08am
The Ministry of Food and Drug Safety (MFDS) is reportedly conducting a review of whether to urgently import anakinra (brand name Kineret) for the treatment of severe adverse reactions associated with CAR-T cell therapy. On June 2nd, in response to an official inquiry from specialized journalists, MFDS stated, "MFDS is currently reviewing
Policy
National Office of Investigation announces rebate crackdown
by
Lee, Jeong-Hwan
Jul 4, 2025 06:06am
Amidst the National Police Agency's announcement of a special crackdown on illegal drug rebates following the launch of the new administration, the Ministry of Health and Welfare is also busy assessing the situation. The MOHW plans to actively consult with the National Police Agency if it receives a specific request for cooperation to crac
Policy
Pressures to reform Korea's drug pricing system
by
Lee, Tak-Sun
Jul 2, 2025 06:10am
President Trump's signing of the executive order on May 12 to lower prescription drug prices in the United States to the same level as other countries has deepened the concerns of Korea¡¯s authorities as well. This is because the U.S.&160;Pharmaceutical Research and Manufacturers of America and others are demanding that Korea raise drug
Policy
More generic 'Vimovo' drugs with naproxen+PPI enters the mkt
by
Lee, Tak-Sun
Jun 30, 2025 06:05am
Generic drugs containing the same active ingredients as the 'Vimovo' (naproxen+esomeprazole magnesium trihydrate), a combination of an anti-inflammatory drug and an anti-ulcer agent, are set to be released. A generic has not been approved since Chong Kun Dang's 'Naxen S Tab' was approved in 2024. Considering the characteristics of a generi
Policy
Polivy granted partial reimbursement after 5 years
by
Lee, Tak-Sun
Jun 30, 2025 06:05am
Roche¡¯s Polivy (polatuzumab vedotin), a treatment for diffuse large B-cell lymphoma (DLBCL) that is currently non-reimbursed in Korea, has been added to the reimbursement list as a part of combination therapy. With the listing, the other drugs used in the combination, excluding Polivy, will be reimbursed. This measure is in accordance wi
Policy
Ensuring stable supply of drugs in short supply
by
Lee, Jeong-Hwan
Jun 27, 2025 06:03am
Following President Lee Jae-myung's pledge to establish a stable supply system for drugs with supply shortages, attention is drawn to the Ministry of Health and Welfare's (MOHW) opinion that a social consensus on the criteria and scope of 'supply shortage' is first needed. It is anticipated that legislative review in the National Assembly
Policy
Yungjin, Ildong¡¯s Ofev generics enter market at half price
by
Lee, Tak-Sun
Jun 26, 2025 06:07am
A generic version of Ofev (nintedanib), a treatment for chronic fibrotic interstitial lung disease), will enter the market at half the price of the original drug. With the entry of generic drugs, the Ofev market now faces competition, just two months after the original drug was listed for reimbursement. According to industry sources o
Policy
Daewoong's high-dose generic 'Xeljanz' wins nod
by
Lee, Hye-Kyung
Jun 26, 2025 06:06am
Daewoong Pharmaceutical's oral generic version of 'Xeljanz (tofacitinib),' which is used to treat rheumatoid arthritis, received approval. On June 23, the Ministry of Food and Drug Safety (MFDS) approved Daewoong Pharmaceutical's two dosages of 'Xeltofa Tab': 5 mg and 10 mg. The latest approval grabs attention, particularly because Dae
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