Genmab — April 2024
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On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Rybrevant. PAPILLON -amivantamab in combination with carboplatin and
pemetrexed for the first-line treatment https://www.ema.europa.eu/en/medicines/human/variation/rybrevant -
tisotumab vedotin submission in japan
https://genmab.co.jp/pressrelease/ -
AMGEN TO SUBMIT TEPROTUMUMAB MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY https://www.amgen.com/newsroom/press-releases/2024/04/amgen-to-submit-teprotumumab-marketing-authorization-application-to-the-european-medicines-agency
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In March 2024, Amgen submitted a marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain, a New Drug Submission (NDS) to Health Canada and an application to the Therapeutic Goods Administration (TGA) in Australia for teprotumumab. Teprotumumab is also under review by the Ministry of Health, Labour and Welfare (MHLW) in Japan.
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Godmorgen
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Genmab-partner vil have Tepezza godkendt i EU
i dag kl. 08:04 ∙ MarketWireGenmabs amerikanske partner Amgen vil have øjenmidlet Tepezza godkendt til markedsføring i EU.
Det skriver Amgen i en pressemeddelelse ifølge Medwatch.
I pressemeddelelsen oplyses det, at Amgen har indsendt en markedsføringsansøgning for Tepezza til de europæiske myndigheder.
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Tepezza er udviklet af Genmab til øjensygdommen Thyroid Eye Disease (TED) og har siden starten af 2020 været godkendt i USA.
Salget har i USA hidtil været varetaget af selskabet Horizon Therapeutics, der i oktober 2023 blev opkøbt af Amgen.
Hvis Tepezza, der er baseret på virkemidlet Teprotumumab, godkendes, vil det ifølge Medwatch være det eneste lægemiddel, der er godkendt til behandling af TED i EU. Midlet markedsføres desuden i Brasilien og Saudi-Arabien.
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Amgen har endvidere ansøgt om markedsføringstilladelse i Storbritannien, Canada og Australien, og også i Japan er man ved at gennemgå godkendelsesprocessen.
Genmab modtager royaltybetalinger for salget af Tepezza.
Link til originalartikel: https://medwatch.dk/Medicinal___Biotek/article17059845.ece
.\˙ MarketWire
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Transactions in Connection with Share Buy-back Program Genmab https://www.proinvestor.com/investornyt/1151698/transactions-in-connection-with-share-buy-back-program-genmab
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