GlobeNewswire: Zealand Pharma A/S Contains the last 10 of 662 releaseshttp://www.globenewswire.com/External?Length=42024-03-19T01:39:58ZGlobeNewswirehttp://www.globenewswire.com/External?Length=4newsdesk@globenewswire.com (NewsDesk)https://www.globenewswire.com/news-release/2016/08/19/865650/0/en/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.html?f=22&fvtc=4&fvtv=8457Zealand 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 diabetes2016-08-19T22:23:08Z<![CDATA[ -- 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 FDA has extended their review time by three months
-- A regulatory decision on iGlarLixi in the U.S. is now expected at the end
of November 2016
-- Zealand’s financial guidance for 2016 remains unchanged
Copenhagen, 20 August 2016 – Zealand Pharma (Zealand) announced today that
Sanofi ha]]>https://www.globenewswire.com/news-release/2016/08/19/865650/0/da/Zealand-meddeler-ny-tidsfrist-for-en-FDA-afg%C3%B8relse-vedr%C3%B8rende-iGlarLixi-pr%C3%A6miks-kombinationen-af-lixisenatid-Adlyxin-Lyxumia-og-Lantus-til-type-2-diabetes.html?f=22&fvtc=4&fvtv=8457Zealand meddeler ny tidsfrist for en FDA-afgørelse vedrørende iGlarLixi, præmiks-kombinationen af lixisenatid (Adlyxin™/Lyxumia®) og Lantus®, til type 2-diabetes2016-08-19T22:23:08Z<![CDATA[ -- 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 behandlingstid med tre måneder
-- En regulatorisk afgørelse vedrørende iGlarLixi i USA ventes nu inden
udgangen af november 2016
-- Zealand fastholder sine resultatforventninger til 2016
København, 20. august 2016 – Zealand Pharma (Zealand) meddeler, at Sanofi har
indsendt opdater]]>https://www.globenewswire.com/news-release/2016/08/17/864816/0/en/Notice-of-Zealand-s-interim-report-for-H1-2016-and-related-conference-call.html?f=22&fvtc=4&fvtv=8457Notice of Zealand’s interim report for H1 2016 and related conference call2016-08-17T11:17:29Z<![CDATA[ -- 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 website.
Copenhagen, 17 August 2016 – Zealand Pharma (Zealand) confirms the release of
its interim report for H1 2016 on Thursday 25 August 2016 in accordance with
the company’s financial calendar. The release can be expected in the morning.
Conference call on Thursday, 25 August 201]]>https://www.globenewswire.com/news-release/2016/08/17/864816/0/da/Dato-for-offentligg%C3%B8relse-af-Zealands-del%C3%A5rsrapport-for-1-halv%C3%A5r-2016-samt-tilh%C3%B8rende-telefonkonference.html?f=22&fvtc=4&fvtv=8457Dato for offentliggørelse af Zealands delårsrapport for 1. halvår 2016 samt tilhørende telefonkonference2016-08-17T11:17:29Z<![CDATA[ -- 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.
København, 17. august, 2016 – Zealand Pharma (Zealand) bekræfter, at selskabets
delårsrapport for 1. halvår 2016 vil blive offentliggjort torsdag, 25. august
2016 i overensstemmelse med virksomhedens finansielle kalender.
Offentliggørelsen forventes at finde sted om morgenen.
Telefonko]]>https://www.globenewswire.com/news-release/2016/08/11/863678/0/en/Phase-II-results-with-dasiglucagon-ZP4207-support-its-potential-for-use-in-a-ready-to-use-rescue-pen-to-treat-severe-hypoglycemia-in-diabetes.html?f=22&fvtc=4&fvtv=8457Phase II results with dasiglucagon (ZP4207) support its potential for use in a ready-to-use rescue pen to treat severe hypoglycemia in diabetes2016-08-11T18:28:03Z<![CDATA[
-- 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
-- Zealand plans to discuss the trial results with the FDA later in 2016 to
define the next development steps for dasiglucagon as a single-dose rescue
treatment
Copenhagen, 11 August 2016 – Zealand Pharma (Zealand) announces supportive
results from a Phase II trial with]]>https://www.globenewswire.com/news-release/2016/08/11/863678/0/da/Fase-II-resultater-underst%C3%B8tter-dasiglukagons-ZP4207-potentiale-som-en-pen-klar-til-brug-til-n%C3%B8dbehandling-af-akut-sv%C3%A6r-hypoglyk%C3%A6mi-i-diabetes.html?f=22&fvtc=4&fvtv=8457Fase II-resultater understøtter dasiglukagons (ZP4207) potentiale som en pen ”klar-til-brug” til nødbehandling af akut, svær hypoglykæmi i diabetes2016-08-11T18:28:03Z<![CDATA[
-- 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 hypoglykæmi
-- Det er Zealands plan at diskutere studieresultaterne med FDA senere i 2016
for at fastlægge næste trin i udviklingen af dasiglukagon som en
enkelt-dosis nødbehandling
København, 11. august 2016 – Zealand Pharma (Zealand) meddeler, at der er
opnået underst]]>https://www.globenewswire.com/news-release/2016/07/29/860000/0/da/Licensindt%C3%A6gtsrapport-for-2-kvt-2016-og-opdatering-p%C3%A5-lixisenatid-Lyxumia-AdlyxinTM-og-iGlarLixi.html?f=22&fvtc=4&fvtv=8457Licensindtægtsrapport for 2. kvt. 2016 og opdatering på lixisenatid (Lyxumia®/AdlyxinTM) og iGlarLixi2016-07-29T05:36:19Z<![CDATA[ -- 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 Adlyxin(TM) til
behandling af type 2-diabetes, og Sanofi forventes at lancere lægemidlet i
USA senere i 2016
København, 29. juli 2016 – Zealand Pharma (Zealand) meddeler, at
licensindtægterne fra Sanofis globale salg af Lyxumia® (lixisenatid uden for
USA) i 2. kvartal 2016 udgjorde 6,4 mio. kr. Licensindtæ]]>https://www.globenewswire.com/news-release/2016/07/29/860000/0/en/Royalty-report-for-Q2-2016-and-update-on-lixisenatide-Lyxumia-AdlyxinTM-and-iGlarLixi.html?f=22&fvtc=4&fvtv=8457Royalty report for Q2 2016 and update on lixisenatide (Lyxumia®/AdlyxinTM) and iGlarLixi2016-07-29T05:36:19Z<![CDATA[ -- 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 Adlyxin(TM) to treat type 2
diabetes, and commercial launch by Sanofi in the U.S. is expected later in
H2 2016
Copenhagen, 29 July 2016 – Zealand Pharma (Zealand), a biotechnology company,
reports royalty revenue from Sanofi’s global sales of Lyxumia® (lixisenatide
outside the U.S.) of DKK 6.]]>https://www.globenewswire.com/news-release/2016/07/28/859512/0/da/FDA-godkender-lixisenatid-under-navnet-AdlyxinTM-til-behandling-af-voksne-med-type-2-diabetes-i-USA.html?f=22&fvtc=4&fvtv=8457FDA godkender lixisenatid under navnet AdlyxinTM til behandling af voksne med type 2-diabetes i USA2016-07-28T04:08:12Z<![CDATA[ -- 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 behandler i øjeblikket en registreringsansøgning for iGlarLixi, et
præmiks- kombinationsprodukt af Adlyxin(TM) (lixisenatid) og Lantus®
(insulin glargin) med forventet afgørelse i august 2016
-- Under aftalen med Sanofi er Zealand berettiget til at modtage resterende
milepæls-b]]>https://www.globenewswire.com/news-release/2016/07/28/859512/0/en/FDA-approves-lixisenatide-as-AdlyxinTM-for-the-treatment-of-adults-with-type-2-diabetes-in-the-U-S.html?f=22&fvtc=4&fvtv=8457FDA approves lixisenatide as AdlyxinTM for the treatment of adults with type 2 diabetes in the U.S.2016-07-28T04:08:12Z<![CDATA[ -- 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 reviewing iGlarLixi, the fixed-ratio combination of
Adlyxin(TM)(lixisenatide) and Lantus® (insulin glargine), with regulatory
decision expected in August 2016
-- Zealand is eligible to receive remaining milestone payments of up to $135
million as well as royalties on global]]>