![Zealand meddeler ny](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Zealand meddeler ny tidsfrist for en FDA-afgørelse vedrørende iGlarLixi, præmiks-kombinationen af lixisenatid (Adlyxin™/Lyxumia®) og Lantus®, til type 2-diabetes
August 19, 2016 18:23 ET
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Zealand Pharma A/S
Som en del af registreringsansøgningen for iGlarLixi har FDA anmodet Sanofi om opdateret information på injektionspennen, hvilket er indsendt
I forlængelse heraf har FDA forlænget deres...
![Zealand announces ne](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Zealand announces new timelines for a U.S. FDA decision on iGlarLixi, the fixed-ratio combination of lixisenatide (AdlyxinTM) and Lantus®, for the treatment of type 2 diabetes
August 19, 2016 18:23 ET
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Zealand Pharma A/S
The FDA had requested updated information on the pen delivery device for iGlarLixi as part of its New Drug Application, which has been submitted by Sanofi
Consequently, the...
![Dato for offentliggø](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Dato for offentliggørelse af Zealands delårsrapport for 1. halvår 2016 samt tilhørende telefonkonference
August 17, 2016 07:17 ET
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Zealand Pharma A/S
På dagen for offentliggørelse, torsdag 25. august 2016 kl. 14.00 afholder Zealands ledelse en telefonkonference. Telefonkonferencen kan tilgås via webbaseret lydspor fra Zealands hjemmeside....
![Notice of Zealand’s](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Notice of Zealand’s interim report for H1 2016 and related conference call
August 17, 2016 07:17 ET
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Zealand Pharma A/S
On the day of release, Thursday 25 August 2016 at 2.00pm CET, Zealand’s senior management will host a conference call. The conference call can be accessed via live audio webcast from Zealand’s...
![Phase II results wit](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Phase II results with dasiglucagon (ZP4207) support its potential for use in a ready-to-use rescue pen to treat severe hypoglycemia in diabetes
August 11, 2016 14:28 ET
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Zealand Pharma A/S
In the Phase II trial, all type 1 diabetes patients treated with dasiglucagon had a clinically relevant increase in blood glucose levels after an insulin-induced hypoglycemic event...
![Fase II-resultater u](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Fase II-resultater understøtter dasiglukagons (ZP4207) potentiale som en pen ”klar-til-brug” til nødbehandling af akut, svær hypoglykæmi i diabetes
August 11, 2016 14:28 ET
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Zealand Pharma A/S
I fase II-studiet opnåede alle type 1-diabetikere, som blev behandlet med dasiglukagon, en klinisk relevant stigning i deres blodsukkerniveau efter et tilfælde af insulin-induceret...
![Licensindtægtsrappor](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Licensindtægtsrapport for 2. kvt. 2016 og opdatering på lixisenatid (Lyxumia®/AdlyxinTM) og iGlarLixi
July 29, 2016 01:36 ET
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Zealand Pharma A/S
Licensindtægter på 6,4 mio. kr. fra Sanofis salg af Lyxumia® (lixisenatid uden for USA) i 2. kvt. 2016
FDA i USA godkendte fornylig lixisenatid under navnet AdlyxinTM til behandling af type...
![Royalty report for Q](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
Royalty report for Q2 2016 and update on lixisenatide (Lyxumia®/AdlyxinTM) and iGlarLixi
July 29, 2016 01:36 ET
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Zealand Pharma A/S
Royalty revenue of DKK 6.4 million / €0.9 million in Q2 2016 on Sanofi’s sales of Lyxumia® (lixisenatide outside the U.S.)
Recently, the U.S. FDA approved lixisenatide as AdlyxinTM to treat...
![FDA approves lixisen](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
FDA approves lixisenatide as AdlyxinTM for the treatment of adults with type 2 diabetes in the U.S.
July 28, 2016 00:08 ET
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Zealand Pharma A/S
Approval paves the way for launch by Sanofi of the first Zealand invented product in the U.S.
Triggers a $5 million milestone payment from Sanofi
FDA is currently...
![FDA godkender lixise](/news-release/logo/356649/0/356649.jpg?lastModified=12%2F09%2F2016%2022%3A41%3A25&size=2)
FDA godkender lixisenatid under navnet AdlyxinTM til behandling af voksne med type 2-diabetes i USA
July 28, 2016 00:08 ET
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Zealand Pharma A/S
Godkendelsen baner vej for, at Sanofi kan lancere det første lægemiddel, opfundet af Zealand, i USA
Udløser en milepælsbetaling på 34 mio. kr. fra Sanofi
FDA...