Zealand Pharma CEO: Contract manufacturer has resolved issues behind FDA rejection

The total delay for a possible approval could end up being almost a year.

Adam Steensberg, CEO of Zealand Pharma. | Photo: Stine Bidstrup

Zealand Pharma experienced an unexpected rejection when the US Food and Drug Administration (FDA) refused to approve the company’s drug dasiglucagon for congenital hyperinsulinism.

Already a subscriber?Log in here

Read the whole article

Get access for 14 days for free. No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

With your free trial you get:

Access all locked articles

Receive our daily newsletters

Access our app

Get full access for you and your coworkers

Start a free company trial today

Former Novo Nordisk CEO failed to inform FDA of guideline breach
For subscribers
Brazilian pharma firms gear up for Novo Nordisk generics push
For subscribers
Roche to receive FDA ruling on food allergy indication soon
For subscribers

Sign up for our newsletter

Stay ahead of development by receiving our newsletter on the latest sector knowledge.

Newsletter terms

Front page now

Former Demant Executive Vice President Arne Boye Nielsen was found responsible for creating an "unsafe psychological work environment" in an internal legal investigation. | Photo: Demant / Pr

Hearing health

Demant Foundation continues to work with ousted Demant executive

While the findings of a legal investigation were so serious that a Demant executive was fired, the majority owner of the hearing aid company subsequently elected him to several boards.

Sacked Demant executive receives USD 2.6 million golden handshake

Demant Board has "full confidence" in management's handling of unsafe work environment

For subscribers

Hearing health

CHMP recommends ten new medicines in June

For subscribers

Foto: George Frey/Reuters/Ritzau Scanpix

Pharma & biotech

Cosmetic Ozempic use under fire in EU amid drug shortages

Regulation

CHMP recommends conditional approval for Genmab and Abbvie's epcoritamab

For subscribers

Pharma & biotech

Pharmacosmos calls off the hunt for investors

For subscribers

Pharma & biotech

Novo to limit Wegovy’s China launch to avoid global disruption

Analyst on Novo Nordisk writedown: "It is a reminder of the risks"

On Wednesday, Novo Nordisk made a write-down of DKK 5.7bn (USD 817m) after a failed study.

Novo Nordisk snaps up partner's hemophilia candidate and gene editing technology

A five-year collaboration is coming to an end as Novo Nordisk has decided to acquire a drug candidate and gene technology from its former partner.

For subscribers

Bavarian Nordic expects Jynneos to be fully effective against new mpox variant

Bavarian Nordic’s vaccine Jynneos is the only approved vaccine against the disease mpox.

Novo Nordisk implements hiring freeze in certain departments

Since 2021, Novo Nordisk has increased its number of employees by 20,000 to total 66,000.

For subscribers

Foto: Medwatch/photo by Ulrich Quistgaard

Genmab cancer drug approved in new indication in US

Epkinly has become the first and only subcutaneously administered T-cell engaging bispecific antibody approved in the US for the treatment of this patient population.

Novo Nordisk blood pressure candidate ends in USD 817m flop

Novo Nordisk acquired ocedurenone from KBP Biosciences in 2023.

Novo Nordisk implements hiring freeze in certain departments

Since 2021, Novo Nordisk has increased its number of employees by 20,000 to total 66,000.

For subscribers

Hearing health

Demant Foundation continues to work with ousted Demant executive

While the findings of a legal investigation were so serious that a Demant executive was fired, the majority owner of the hearing aid company subsequently elected him to several boards.

For subscribers

Pharma & biotech

Cosmetic Ozempic use under fire in EU amid drug shortages

The success of Novo Nordisk’s Ozempic and Wegovy as well as blockbuster shots made by rival Eli Lilly has left some patients with diabetes struggling to continue their treatment.

Pharma & biotech