- Policy
- 780,000 doses of Comirnaty 2 will be national lot released
- by Lee, Hye-Kyung Oct 17, 2022 06:03am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that the mRNA COVID-19 vaccine imported by Pfizer Pharmaceutical Co. released 780,000 doses of Comirnaty 2 for two weeks on October 14. National lot release refers to a system that comprehensively evaluates the results of tests and testing results for each lot before vacci
- Policy
- Hemlibra's benefit speeds up to strengthen accessibility
- by Lee, Jeong-Hwan Oct 17, 2022 06:03am
- Kim Sun-min, director of the HIRA, promised to speed up the Hemophilia treatment Hemlibra benefit screening to strengthen accessibility for patients. On the 13th, Kim Sun-min, director of the HIRA, answered the on-site questioning of Kang Sun-woo, a lawmaker of the Democratic Party of Korea, at the NHIS parliamentary audit. Lawmaker Kang S
- Policy
- Proposal for improvement of omission of PE data submission
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- Critics said the HIRA's plan to improve the PE data submission system is actually reducing the scope of application of drugs that can be omitted. It is pointed out that the amendment should be fully reviewed as an amendment to destroy President Yoon Suk Yeol's pledge to expand the coverage of severe and rare diseases. On the 13th, Kang Sun-wo
- Policy
- CDDC blindly opposes applying RSA to Tabrecta and Rybrevant
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- The National Assembly criticized how the Cancer Disease Deliberation Committee has been undermining the purpose of the Risk-Sharing Agreement system that waives submission of PE evaluation data and disapproved reimbursement of anticancer drugs and rare disease treatments. The committee has not allowed reimbursement of these drugs that ha
- Policy
- National lot release for Moderna's bivalent COVID-19 vaccine
- by Lee, Hye-Kyung Oct 13, 2022 06:08am
- The 1.57 million courses of the bivalent vaccine manufactured by Samsung Biologics have been approved for national lot release. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the national lot release for 1.57 million courses of Moderna Korea’s domestically manufactured mRNA bivalent COVID-19 v
- Policy
- The loss of health insurance is close to 200 billion won
- by Lee, Jeong-Hwan Oct 13, 2022 06:08am
- Rep. Nam In-soon said, "The Legislation and Judiciary Committee's pending bill to recover the reduction will be dealt with." Over the past decade, health insurance benefit losses amounted to 19.7 billion won for 17 cases in which pharmaceutical companies lost lawsuits related to weak cuts and re-evaluation. Critics point out that the revision of
- Policy
- 99 items were granted generic exclusivity, none reimbursed
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Although 99 items were granted generic exclusivity, none of the items were granted reimbursement during the period. This was what happened to generics of Boehringer Ingelheim’s Jardiance Duo (empagliflozin+metformin hcl). Although a large number of products were approved and even obtained generic exclusivity, the drugs were unsellable in
- Policy
- Ponesimod's Domestic Item License
- by Lee, Hye-Kyung Oct 12, 2022 05:50am
- Ponesimod of Janssen Korea, a rare drug for treating multiple sclerosis, has been approved for domestic items. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 11th that it has approved Ponesimo for the treatment of recurrent dysplasia in adults. The drug has been shown to reduce inflammatory reactions by block
- Policy
- Alvogen’s Alymsys reimbursed...compete with Avastin similar
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market. Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market. With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in th
- Policy
- Two companies' Ticagrelor can be reimbursed
- by Lee, Tak-Sun Oct 7, 2022 06:04am
- As Kukje and Korea United Pharmaceutical newly entered the anti-thrombotic Ticagrelor market, it was reorganized into a competitive system for nine companies. Although the original Brilinta's material patent expired in November last year, only six pharmaceutical companies' products entered the market due to high manufacturing costs and lack o
