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2025-11-05 03:59
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Policy
Generic exclusivity of Ticagrelor terminated but no benefits
by
Lee, Tak-Sun
Aug 16, 2022 05:47am
Anti-thrombotic Ticagrelor have disappeared, but no news of generic benefit has been heard. Since the expiration of material patents in November last year, six pharmaceutical companies, including Chong Kun Dang, have registered their benefits, but pharmaceutical companies that have obtained generic exclusivity or later approved have been
Opinion
[Reporter¡¯s View] MFDS opens up, discloses contact info
by
Lee, Hye-Kyung
Aug 16, 2022 05:46am
The Ministry of Food and Drug Safety is changing. The ministry's efforts to transform into an ¡®Open MFDS¡¯ as emphasized by Minister Yu-Kyoung Oh since her day of appointment on May 27th, is showing results. After holding 7 ¡®ultimate debate¡¯ sessions in June this year, the MFDS also held 16 roundtable meetings and discussion sessions w
Policy
Why AZ¡¯s vaccine was used as comparator for SKY Covione
by
Lee, Hye-Kyung
Aug 16, 2022 05:46am
The minutes of the Central Pharmaceutical Affairs Council¡¯s meeting that reviewed the first homegrown COVID-19 vaccine - SK Bioscience¡¯s 'hasCovione multi inj.¡¯ &8211; have now been disclosed. The minutes contained discussions on the reason why a vaccine from a different platform was selected as the control vaccine for SKY Covione, whethe
Company
Will the situation in the Atozet market improve?
by
Kim, Jin-Gu
Aug 16, 2022 05:46am
With the revision of guidelines for treating hyperlipidemia in Korea announced, attention is focused on how it will affect the prescription performance of major drugs. The pharmaceutical industry predicts that the Atorvastatin and Ezetimibe market, which has recently been growing rapidly, will benefit the most from the revision of the guideli
Policy
The regulation for shortening the period will be revised
by
Lee, Hye-Kyung
Aug 16, 2022 05:46am
As announced by the government, if the RSA-applied drugs are subject to PE submission, the registration period will be shortened, and even drugs that have proven improvement in children's quality of life will be excluded. The HIRA will pre-announce the "Partial Amendment Regulations on the Evaluation Standards and Procedures for Medical Care
Company
Wakix, a new narcolepsy drug, can be prescribed at Big 5
by
Eo, Yun-Ho
Aug 12, 2022 05:58am
Wakix, a new narcolepsy drug, can be prescribed at the Big 5 General Hospital. According to the industry, it is Mitsubishi Tanabe Pharma's Wakix recently passed the DC of the Big 5, including Samsung Seoul Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Wakix has been on the insurance benefit list since February, forming
Opinion
[Reporter¡¯s View] Seek industry opinion before implemention
by
Lee, Tak-Sun
Aug 12, 2022 05:58am
Although the government announced measures to reinforce patient access to high-priced severe disease treatments on the 20th of last month, the pharmaceutical industry¡¯s response to the new measures has been lukewarm at best. Moreover, the industry is ferociously criticizing how the government presented the measure without collecting industr
Policy
The Price of 4 Xarelto will be cut from the 22nd as planned
by
Kim, Jung-Ju
Aug 12, 2022 05:58am
As the court sided with the government for the four items of the Bayer Korea Xarelto (Rivaroxaban) series, which the government has lowered the insurance drug price through ex officio adjustment and ended the additional application, the drug price cut schedule was set. On the 22nd, the drug price will fall as originally planned by the governm
Policy
CKD completes acquiring 3 exclusive licensed items
by
Lee, Tak-Sun
Aug 12, 2022 05:58am
Chong Kun Dang completed the acquisition process for the three items that it signed exclusive sales agreements for with foreign pharmaceutical companies last year. All three items are known to have a prior history with Chong Kun Dang. According to industry sources on the 11th, Chong Kun Dang has been receiving insurance reimbursement for
Policy
Ceprotin, Takeda's rare dz, gives 11 yrs for reexamination
by
Lee, Hye-Kyung
Aug 12, 2022 05:57am
On the 2nd, Takeda's Ceprotin, which was first approved as a treatment for severe congenital protein C deficiency in Korea, was given an 11-year review period after marketing. Severe congenital protein C deficiency is a rare genetic disease that causes fatal defects in blood clot control due to a lack of protein C, a type of vitamin K-depende
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