- 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
- Policy
- Innovative pharmaceutical companies' new drug tx
- by Lee, Jeong-Hwan Oct 7, 2022 06:03am
- It was also pointed out that the government is delaying the preparation of a sub-law of a clause that favors the price of new drugs developed by innovative pharmaceutical companies in the Special Act on the Promotion of the Pharmaceutical Industry. Critics say that it has not been active in subsequent legislation such as enforcement ordinance
- Policy
- The incidence of adverse effects in Alecensa is 80%
- by Lee, Hye-Kyung Oct 6, 2022 06:05am
- A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that c
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 6, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinica
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 5, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, t
- Policy
- Pfizer Corona vaccine passed a verification advisory group
- by Lee, Hye-Kyung Oct 5, 2022 06:10am
- The Ministry of Food and Drug Safety (Director Oh Yoo-Kyung) announced on the 30th that Pfizer Pharmaceutical's COVID-19 vaccine "Comirnaty 2 0.1mg/mLP (Initial Virus of COVID-19, Omicron (BA.1)") passed the COVID-19 vaccine safety and effectiveness verification advisory group. The advisory group held a meeting on the 29th and proved its
- Policy
- Post-marketing surveillance of breast cancer drug Kadcyla
- by Lee, Hye-Kyung Oct 4, 2022 06:07am
- A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’ With 163 additional cases of unexpected ADRs whose causal relationship cannot b
