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2025-11-05 16:33
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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
Company
2 CGRP Migraine New Drugs
by
Eo, Yun-Ho
Jan 6, 2023 05:57am
Teva-Handok's Calcitoninene-related peptide (CGRP) targeted migraine treatment Ajovy has been covered by insurance benefits since January, and it will fight for prescription leadership with Emgality of Lily Korea, which was listed in September last year. The two drugs are in the same family, but there are differences in usage dosage, so choic
Company
Phase 1 of HLB Apixaban was approved
by
Lee, Seok-Jun
Jan 6, 2023 05:56am
HLB Pharmaceutical has received approval from the Ministry of Food and Drug Safety for phase 1 in Korea, which develops the oral thrombosis treatment Eliquis in the form of a long-term continuous injection (HLBP-024). According to the company on the 4th, HLBP-024 is a treatment developed independently based on HLB Pharmaceutical's long-term c
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
Company
Celltrion Remsima is licensed in 100 countries
by
Kim, Jin-Gu
Jan 6, 2023 05:56am
Celltrion announced on the 3rd that Remicade biosimilar Remsima has been licensed in 100 global countries 10 years after its domestic approval in 2012. Remsima is a biosimilar of TNF-&4363;&4453;&4520;&4364;&4454; inhibitors used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn'
Company
Bayer and Boryung are competing in the aspirin market
by
Nho, Byung Chul
Jan 4, 2023 05:32am
In the market for aspirin-based cardiovascular treatments, Bayer Aspirin Protect 100 mg was found to be the undisputed No. 1. According to medical distribution performance data, Aspirin Protect recorded 18.8 billion won last year and is leading the market while maintaining the appearance of banding worth 20 billion won. Aspirin Protect's sale
Company
Will Tagrisso finally be reimb in the 1st line after 4 yrs?
by
Eo, Yun-Ho
Jan 4, 2023 05:32am
Whether the third-generation targeted anticancer drug Tagrisso will be able to receive reimbursement expansions in 2023 is gaining attention According to industry sources, AstraZeneca Korea submitted additional supplementary data to extend reimbursement of its EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment to the fir
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
Company
ablbio will receive 32 billion won in technical fee
by
Jan 4, 2023 05:32am
1 trillion won technology export contract in January last year...Get 150 billion won in total. ablbio announced on the 2nd that it will receive $25 million (31.7 billion won) in short-term stages following the first administration of the dual antibody "ABL301" from Sanofi. The milestone is 594.2% of ablbio's sales of 5.3 billion won as of the
Company
CTLA-4 inhibitor Imjudo is expected to commercialize
by
Eo, Yun-Ho
Jan 4, 2023 05:32am
The second CTLA-4 inhibition mechanism is expected to be commercialized in Korea this year. According to related industries, the Ministry of Food and Drug Safety is reviewing for approval of CTLA-4 inhibitor Imjudo, a combination therapy partner of AstraZeneca Korea's PD-L1 inhibitor Imfinzi. The combination therapy of Impinzi and Imjudo was
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