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2025-10-27 13:40
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Reimb discussion on Braftovi and Luxturna continue next year
by
Eo, Yun-Ho
Dec 18, 2023 05:31am
Industry attention is focused on the fate of the two new drugs that were unable to pass the final stage to reimbursement in Korea. According to industry sources, Ono Pharma Korea¡¯s colorectal cancer drug Braftovi (encorafenib) and Novartis' retinal disease drug Luxterna (voretigene neparvovec-rzyl) have entered into extended negotiations
Company
SK pneumococcal conjugate vaccine nears global entry
by
Chon, Seung-Hyun
Dec 15, 2023 05:51am
SK Bioscience is fast-tracking its global market strategy for its next-generation pneumococcal vaccine. Nine years following the start of their joint development with Sanofi, the company has now progressed to the last phase of clinical trials for commercialization. SK Bioscience has also been improving its vaccine production facilities to prepar
Policy
Global orphan drug Lamzede receives GIFT designation
by
Lee, Hye-Kyung
Dec 15, 2023 05:51am
'Lamzede Inj (velmanase)¡¯ received the Global Innovative Products on Fast Track (GIFT) designation and will receive an expedited review in Korea. Lamzede is an orphan drug for which Kwang Dong Pharmaceutical signed an exclusive sales and distribution agreement with Italy's Chiesi Farmaceutical in July this year. As the GIFT program see
Policy
HER2-positive metastatic breast cancer drug Tukysa approved
by
Lee, Hye-Kyung
Dec 15, 2023 05:51am
The Ministry of Food and Drug Safety (MInister: Yu-kyoung Oh) approved two dosage forms (50mg, 150mg) of MSD Korea¡¯s new breast cancer drug Tukysa (tucatinib) on the 14th. The drug is used in combination with trastuzumab and capecitabine, for patients with locally advanced or metastatic HER2-positive breast cancer who have received two o
Company
Reimb for Cold Agglutinin Disease drug Enjaymo starts in KOR
by
Eo, Yun-Ho
Dec 15, 2023 05:51am
The cold agglutinin disease treatment ¡®Enjaymo¡¯ is seeking reimbursement listing in Korea. According to industry sources, Sanofi Korea has filed a reimbursement application for its Enjaymo (sutimlimab) as a treatment for hemolysis in adult patients with Cold Agglutinin Disease (CAD) Enjaymo¡¯ is a first-in-class humanized monoclonal
Company
US-expanded Cresemba faces reimb challenges in KOR
by
Son, Hyung-Min
Dec 15, 2023 05:51am
The antibiotic Cresemba has received expanded indications in the US to include pediatric patients. However, in Korea, the reimbursement for Cresemba is being delayed because of challenges in economic evaluations, limiting patient access to this medication. According to the industry on the 15th, the U.S. Food and Drug Administration (FDA) appr
Policy
Non-inferior drugs likely to receive preferential pricing
by
Lee, Tak-Sun
Dec 15, 2023 05:51am
Non-inferior drugs from Korea innovative pharmaceutical companies will likely be eligible for preferential drug pricing starting next year. Previously, non-inferior drugs were priced below the weighted average of alternative drugs. However, through improvement measures, if the patent of an alternative drug is still active, non-inferior d
Company
Domestic market withdrawal of Forxiga remains a mystery
by
Kim, Jin-Gu
Dec 14, 2023 05:47am
AstraZeneca¡¯s decision to withdraw its SGLT-2 inhibitor diabetes drug Forxiga (dapagliflozin) from the Korean market is being considered an unusual move by the industry. This is because the decision to pull out of the Korean market would essentially mean giving up KRW 50 billion in annual sales for AstraZeneca. While AstraZeneca's offi
Company
Rinvoq is granted reimb for ankylosing spondylitis
by
Son, Hyung-Min
Dec 14, 2023 05:47am
The use of JAK inhibitors, which had been used for rheumatoid arthritis and atopic dermatitis, has been expanded to ankylosing spondylitis. On the 13th, AbbVie Korea held a press conference at Andaz Seoul Gangnam in Gangnam-gu, Seoul to celebrate the reimbursement of its Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib) for severe acti
Company
Reimb of latecomer leukemia drug Bosulif imminent
by
Eo, Yun-Ho
Dec 14, 2023 05:47am
Bosulif, a new leukemia treatment, is expected to receive reimbursement next year. According to the pharmaceutical industry, Pfizer Korea successfully completed drug pricing negotiations with the National Health Insurance Service for Bosulif (bosutinib), a Chronic Myelogenous Leukemia (CML) treatment. Bosulif will be presented to the
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