- Policy
- Manufacturing for development allowed during suspensions
- by Lee, Hye-Kyung Aug 19, 2022 05:53am
- An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period. According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for pr
- Policy
- We need to increase the rate of PO tx for COVID-19 crisis
- by Lee, Jeong-Hwan Aug 19, 2022 05:53am
- In order to respond to the increase in the number of patients with COVID-19, it was pointed out that the prescription rate of treatments such as Paxlovid should be raised more than now, while continuing to maintain an environment where prescriptions are quickly prescribed. It was also suggested that the fast track of the COVID-19 high-risk or
- Policy
- KDCA opposes use of Paxlovid in healthy 50s
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- The disease control and prevention authorities have expressed opposition to the plan to lower the prescription age for Pfizer’s oral COVID-19 treatment, Paxlovid, to those in their 50s, on grounds of domestic Emergency Use Authorization standards. The decision was influenced by the fact that eligibility for Paxlovid had already been exte
- Policy
- Why is price different btw patent-expired original/generic
- by Lee, Tak-Sun Aug 18, 2022 05:47am
- The drug price will be lowered to 53.55% of the existing upper limit from the 22nd after losing an administrative lawsuit against the drug price lowered by the anticoagulant Xarelto with the government. As a result, it will be the same as the highest price of generics registered last year. However, the drug price of Xarelto 10mg is expected t
- Policy
- KDCA will announce its plan to inoculate bivalent vaccine
- by Lee, Jeong-Hwan Aug 17, 2022 05:52am
- The domestic quarantine authorities plan to announce vaccination plans at the end of this month, including the subject and use of Moderna's bivalent vaccine for COVID-19 omicron. Moderna bivalent vaccine is still in the pre-application stage, and the intention is to make a plan for use in consideration of the effectiveness and safety of va
- Policy
- Novavax vaccine approved for use for 12+ years in Korea
- by Lee, Hye-Kyung Aug 17, 2022 05:52am
- The age eligibility of Novavax’s COVID-19 vaccine will be extended. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the Post Approval Change Application for the COVID-19 vaccine ‘Nuvaxovid Prefilled Syringe,’ developed by Novavax and manufactured by SK Bioscience, to change the vaccination ag
- 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
