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2025-05-08 12:06
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Policy
¡°Will dvlp blockbusters and systemize non-F2F treatment¡±
by
Lee, Jeong-Hwan
Jan 10, 2023 05:35am
The government will reinforce R&D support in the pharmaceutical industry to develop 2 new global blockbuster drugs by 2027, by increasing public-private investments and expanding customized policy support. The government also selected the institutionalization of non-face-to-face treatment and increasing the admissions quota of medical s
Policy
¡è63% of the average annual SA bill
by
Lee, Tak-Sun
Jan 10, 2023 05:33am
Among ultra-high-priced drugs with an annual drug cost of more than 10 million won per patient, RSA contract drugs have increased significantly. It was confirmed that the claims for RSA drugs increased by an average of 62.6% per year. This fact was found in the "Research on the Performance Evaluation and Development Direction of RSA" conducted b
Policy
nAMD & DME tx Vabysmo is about to be approved in Korea
by
Lee, Hye-Kyung
Jan 9, 2023 06:10am
The domestic approval of Vabysmo, the first and only dual-specific antibody biological drug related to eye diseases developed by Roche, is imminent. Vabysmo has been approved as an nAMD treatment and DME treatment in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, and wa
Policy
PMS standards lowered for Sanofi¡¯s hemophilia drug
by
Lee, Hye-Kyung
Jan 6, 2023 05:57am
The post-marketing surveillance (PMS) term for Sanofi¡¯s hemophilia treatment ¡®Eloctate¡¯ and ¡®Alprolix¡¯ has been extended, and the number of subjects reduced. With the risk that the items may be canceled if the company fails to complete PMS for the drugs within the term set within the year, the authorities decided to extend the reeva
Policy
Termination of PVA research services
by
Lee, Tak-Sun
Jan 6, 2023 05:56am
With the completion of the study that derived the improvement plan for PVA, attention is being paid to how it will be reflected in the actual policy. The industry expects the maximum cut rate, which is currently limited to 10%, to change. The NHIS also said it would come up with measures to improve the maximum reduction rate through research
Policy
Approval of Pfizer¡¯s JAK inhibitor Xeljanz Srup imminent
by
Lee, Hye-Kyung
Jan 4, 2023 05:32am
Pfizer¡¯s JAK inhibitor ¡®Xeljanz Syrup (tofacitinib citrate) 1mg/mL¡¯ may soon receive marketing authorization in Korea. According to industry sources on the 3rd, the Ministry of Food and Drug Safety completed the safety and efficacy review for the marketing authorization application Pfizer Korea submitted for Xeljanz Syrup. Generally
Policy
Koselugo is the only non-reimbursed drug among 21
by
Lee, Tak-Sun
Jan 3, 2023 05:41am
The Health Insurance Review and Assessment Service¡¯s Drug Reimbursement Evaluation Committee (DREC) reviewed 21 items last year, among which only 1 failed to pass deliberations and be determined non-reimbursable. This non-reimbursed drug was the neurofibroma treatment ¡®Koselugo Cap.¡¯ Among the other 20, 9 were recognized to be adequate for
Policy
The fast track of tx for serious dz without a substitute
by
Lee, Tak-Sun
Jan 3, 2023 05:40am
Prior consultations will be newly established before the main negotiation to quickly register anticancer drugs without alternative drugs and treatments for severe and rare diseases. Accordingly, the negotiation period for the drug will be reduced from 60 days to 30 days. The NHIS announced on the 30th some revisions to the drug price negotiation
Policy
Will Koselugo, a new neurofibroma drug be reimbursed next ye
by
Lee, Tak-Sun
Jan 3, 2023 05:40am
"Koselugo (Selumetinib, AstraZeneca), the first drug used for childhood neurofibromatosis, a rare disease, is stepping up its challenge." Although he had a hard time at the HIRA in March, efforts to register health insurance have continued since then, such as supplementing data and reapplying for benefits. Starting next year, expectations fo
Policy
Largest-ever drug pricing reeval to be conducted this year
by
Kim, Jung-Ju
Jan 2, 2023 06:04am
The health and pharmaceutical industry is busy preparing various systems and policies for the new year. The reimbursement adequacy reevaluations for listed drugs that had been initiated as a pilot project on choline alfoscerate products settled as an annual policy project and are expected to start full-scale reevaluations on previously not
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