Alvotech hlýtur markaðsleyfi í Bandaríkjunum fyrir Simlandi, líftæknilyfjahliðstæðu við Humira í háum styrk
February 23, 2024 20:15 ET
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Alvotech
Simlandi (AVT02) verður fyrsta líftæknilyfjahliðstæðan á markaði í Bandaríkjunum sem er útskiptanleg við Humira í háum styrkMarkaðsleyfi með útskiptanleika getur veitt einkarétt til markaðssetningar á...
Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®
February 23, 2024 20:15 ET
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Alvotech
SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. SIMLANDI is the first biosimilar approval under the strategic partnership...
Alvotech tilkynnir hvenær sala á AVT04, líftæknilyfjahliðstæðu við Stelara, getur hafist á alþjóðlegum mörkuðum
February 15, 2024 06:30 ET
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Alvotech
Alvotech (NASDAQ: ALVO) tilkynnti í dag að fyrirtækið hafi komist að samkomulagi við Johnson & Johnson (J&J) um það hvenær sala getur hafist á AVT04, líftæknilyfjahliðstæðu við Stelara...
Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (ustekinumab)
February 15, 2024 06:30 ET
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Alvotech
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement...
Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (ustekinumab)
February 15, 2024 06:30 ET
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Alvotech
REYKJAVIK, Iceland, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients...
Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
January 29, 2024 04:00 ET
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Alvotech
The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints Prolia® and Xgeva® (denosumab) are indicated...
Alvotech kynnir jákvæða niðurstöður úr rannsókn á lyfjahvörfum AVT03, fyrirhugaðrar líftæknilyfjahliðstæðu við Prolia og Xgeva
January 29, 2024 04:00 ET
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Alvotech
Aðalendapunktar rannsóknarinnar voru uppfylltir, en henni var ætlað að bera saman lyfjahvörf, öryggi og þolanleika AVT03 og Prolia í heilbrigðum einstaklingum.Prolia og Xgeva (denosumab) eru lyf við...
Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
January 29, 2024 04:00 ET
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Alvotech
The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpointsProlia® and Xgeva® (denosumab) are indicated...
Alvotech birtir upplýsingar um stöðu umsókna um markaðsleyfi fyrir AVT02 og AVT04 í Bandaríkjunum
January 19, 2024 11:30 ET
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Alvotech
Alvotech (NASDAQ: ALVO) tilkynnti í dag að úttekt eftirlitsaðila Matvæla- og lyfjaeftirlits Bandaríkjanna (FDA) á framleiðsluaðstöðu Alvotech í Reykjavík, sem hófst 10. janúar sl., sé nú lokið....
Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04
January 19, 2024 11:30 ET
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Alvotech
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s...