- 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
- 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
- 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
- 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
- Policy
- Gov is reluctant to demand that infants be exempted from PE
- by Lee, Jeong-Hwan Aug 11, 2022 06:03am
- The government expressed reluctance to apply PE omission to rare drugs for infants, children, and adolescents. They say that it is a matter to be carefully considered in consideration of other drugs. On the 10th, the MOHW responded to a written question by Choi Hye-young of the Democratic Party of Korea, a member of the National Assembly's He
- Policy
- Reyvow, a migraine drug aimed at clinicians
- by Lee, Tak-Sun Aug 11, 2022 06:03am
- Ildong Pharmaceutical, which is seeking to introduce the new migraine drug Reyvow in Korea, has decided not to accept the upper limit offered by the Pharmaceutical Benefit Evaluation Committee of the Health Insurance Review and Assessment Service. The measure was decided in consultation with Lilly, who holds the global copyright of the drug,
- Policy
- "May bring 60M courses of Omicron-adapted COVID-19 vaccines"
- by Lee, Jeong-Hwan Aug 11, 2022 06:03am
- The disease control authorities announced that they may introduce the adapted, so-called ‘Omicron-specific COVID-19 vaccines’ as newly introduced amounts if the vaccines receive marketing authorization. In other words, if Moderna’s ‘Moderna Spikevax-2 inj.’ and Pfizer’s ‘Comirnaty-2 inj.’ that are being reviewed by the Ministry o
- Policy
- Will approval of brain function enhancers be revoked?
- by Lee, Hye-Kyung Aug 10, 2022 05:53am
- Whether acetyl-L-carnitine, which failed to verify its efficacy in its ‘secondary degenerative diseases caused by cerebrovascular disease’ indication during clinical reevaluations, will be able to maintain its marketing authorization status will be determined within September this year. The Ministry of Food and Drug Safety issued a Dear Hea
