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2025-09-12 16:28
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Policy
MFDS orders minimized use of varenicline
by
Lee, Tak-Sun
Jul 12, 2021 05:58am
The Ministry of Food and Drug Safety ordered minimized use of the smoking-cessation treatment, ¡®varenicline.¡¯ The measure was announced 3 weeks after safety investigations had started for the products, from the 22nd of last month. The MFDS announced that it has issued a Dear Healthcare Professional Letter regarding the precautions to ta
Policy
Ultra-high-priced drugs(Kymriah) need coverage within a year
by
Lee, Jeong-Hwan
Jul 11, 2021 07:05pm
In order to commercialize high-tech biopharmaceuticals, which are evaluated as ultra-high-priced new drugs, it has been argued that a policy to recognize insurance benefits should follow beyond Expedited Review within at least a year of approval. It is pointed out that although the enactment of the Advanced Regenerative Bio Act in 2019 est
Policy
Early supply of Pfizer in exchange for a vaccine with Israel
by
Kim, Jung-Ju
Jul 11, 2021 07:01pm
The Minister of Health and Welfare, Kwon Deok-chul signed a vaccine swap agreement today (6th), which will receive 700,000 pfizer vaccines from the Israeli government in July and return them sequentially from September to November. Recently, the Israeli government was looking for ways to make effective use of the vaccine, with some of the
Policy
Bayer applies for approval of ¡®Finerenone¡¯ in Korea
by
Lee, Tak-Sun
Jul 9, 2021 05:57am
A groundbreaking new drug developed by Bayer is undergoing review for approval in Korea. The drug is known to inhibit disease progression in chronic kidney disease (CKD) patients with diabetes. According to industry sources on the 8th, Bayer applied for the approval of its ¡®finerenone (Kerendia tab)¡¯ to the Ministry of Food and Drug
Policy
Generic prices are 41-54% more expensive than foreign ones
by
Lee, Hye-Kyung
Jul 7, 2021 05:53am
The level of generic prices in Korea is 41 to 54% higher than that of foreign generics. This leads to an interpretation that if domestic generics are replaced with foreign medicines, 41-54% of costs will be reduced if only tariffs and transportation costs are compared. The findings were recently published by The Korean Association of Heal
Policy
¡®Immunoglobulin inj¡¯ is reimbursed for vaccine-related TTS
by
Lee, Hye-Kyung
Jul 7, 2021 05:52am
Human Immunoglobulin G may now be used with insurance benefits for the treatment of thrombosis thrombocytopenia syndrome (TTS), a known adverse event following COVID-19 vaccinations. Expansion of benefit standards for general drugs usually takes around 80 days, however, due to the specificity of the COVID-19 situation, the reimbursement stan
Policy
Benefit extended for Lipiodol, reduced for Imotun from 23rd
by
Kim, Jung-Ju
Jul 6, 2021 05:50am
Reimbursement benefit for Guerbet Korea¡¯s liver cancer contrast medium Lipiodol Ultra-Fluid (iodised oil, 12.8g/10mL) will be extended to lymphangiography and sialography. On the other hand, reimbursement benefit for Chong Kun Dang Pharmaceutical¡¯s avocado and soyabeam unsaponifiables, Imotun Cap., will be reduced in line with its reduced indi
Policy
Cholib was eventually withdrawn from the domestic market
by
Lee, Tak-Sun
Jul 6, 2021 05:50am
Abbott's Cholib, the first combination of Fenofibrate-Simvastatin released in Korea, will be withdrawn from the Korean market. This is because the Statin-Fenofibrate market was lagging behind domestic pharmaceutical companies and administrative disposition by the MFDS was underway. According to industries on the 2nd, South Korea's Abbott info
Policy
Domestic companies attempt at hemophilia treatment market
by
Moon, sung-ho
Jul 6, 2021 05:50am
Domestic pharmaceutical companies have thrown their hats into the domestic hemophilia treatment market, forewarning a change in the prescription market. The attempts will mainly target the large major hospitals that treat hemophilia, but the possibility of any significant change in the treatment market is considered low in the field. Ac
Policy
Suspension of Execution for Xarelto price cut continues
by
Kim, Jung-Ju
Jul 5, 2021 05:54am
Despite the two price cuts that were previously notified from the ex officio adjustment and expiry of the premium pricing application period, the price of the 4 strengths of Bayer Korea¡¯s Xarelto tab. products will continue to be maintained as is for the time being. The company, which filed a suit against the government regarding the price c
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