Bavarian Nordic — Marts 2021

[Jakob440]

Jeg har fundet indlægssedlen https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf

[Jakob440]

Indlægsgodkendelsen er tilhørende dasiglucagon hypopal.

[Jakob440]

Så må godkendelsen officelt blive meldt ud snart.

[Jakob440]

Nu er det officielt

[exitnu]

Jeg har denne fra mit feed: (men er i tvivl)

Approval Date: 03/22/2021; Drug Name: Zegalogue, Nda #214231; Active Ingredients: DASIGLUCAGON; Company: Zealand Pharma As; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 214231

[Jakob440]

ZEAL: Zealand Sp ADR Latest Stock Price, Analysis, News and Trading Ideas

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Stocktwits (stocktwits.com)

[exitnu]

Zealand Pharma surges on news of FDA approval for dasiglucagon

[exitnu]

Zealand Pharma (NASDAQ:ZEAL) rose in late trading hours to end the day with a ~12.9% gain on the news that its glucagon analog dasiglucagon, with the brand name Zegalogue, won FDA approval, according to a posting on the federal agency’s website.The company hasn’t officially released a statement yet.

[exitnu]

The PDUFA was March 27 for the company’s marketing application for dasiglucagon for congenital hyperinsulinism.Zealand Pharma dropped sharply in December on the announcement of topline data from the first Phase 3 trial evaluating dasiglucagon as a treatment of Congenital Hyperinsulinism (“CHI”).

[exitnu]

Zealand Pharma surges on news of FDA approval for dasiglucagon

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(seekingalpha.com)

[DevOp]

Og her sad man og ventede på godkendelse af HypoPal rescue pen - så er der da basis for lidt mere i løbet af ugen

[Jakob440]

Indlægssedlen lyder også fin. Har lige kort kigget den igennem.

[exitnu]

ZEGALOGUE (dasiglucagon) injection, for subcutaneous use. Initial U.S. Approval: 2021:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf

[Munchi]

er dette ikke hypopalpennen ? hvis nej hvad er det så ?

[DevOp]

Exitnu, det ser jo ud som dasi til Rescue pen mod "severe hypoglycemia" - de nævner bare ikke pennen, men de har tilsyneladende også fået godkendelse til dasi mod
"congenital hyperinsulinism"

[Jakob440]

Godkendelsen er for Dasiglucagon hypopal pennen

[Jakob440]

Pensionisten, det der link er forældet så det skal du bare glemme. Det var såmænd bare en bekræftelse tilbage fra maj 2020, at FDA har modtaget ansøgningen.

[exitnu]

"autoinjector and prefilled syringe are for subcutaneous
injection only"

[Jakob440]

DevOp, det er udelukkende en godkendelse af hypopal pennen.

[DevOp]

Ja, men betyder det så ikke, at "congenital hyperinsulinism" stadig mangler og endda også har PDUFA date d.27. marts?