A part of Watch Media

MedWatchWednesday4 October 2023

  • Latest
  • Search
  • Log in
  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
  • Search
  • Log in
MedWatchWednesday4 October 2023
  • Search
  • Log in
  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
Pharma & biotech

Novo Nordisk facility in the US allegedly receives FDA notice

The FDA has reportedly notified the company’s management of problematic conditions.
Novo Nordisk's manufacturing facility in Clayton, the US. | Photo: Novo Nordisk/pr
Novo Nordisk's manufacturing facility in Clayton, the US. | Photo: Novo Nordisk/pr
by marketwire

Novo Nordisk has been inspected by the US Food and Drug Administration (FDA) at its Clayton facility in the US, which allegedly triggered a notice, highlighting potential regulatory problems.

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
Must contain at least 6 characters
Must contain at least 2 characters
Must contain at least 2 characters

Get full access for you and your coworkers

Start a free company trial today

Share article

Related articles:

  • Photo: Staff

    FDA: Prospects for full supply of Wegovy in the US are unclear

  • Flemming Wagner, adm. direktør hos parallelimportøren Abacus Medicine. | Photo: Pr / Abacus

    Parallel importer sees market for Novo Nordisk obesity drug in new countries

    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

Foto: Tom Little
Pharma & biotech

FDA approves Novo Nordisk drug to treat rare condition

The marketing authorization applies to children and adolescents aged 9 years and older, as well as adults with ”relatively” preserved kidney functions.
  • FDA to review Novo Nordisk drug for rare metabolic disease
  • Huge acquisition scores Novo Nordisk an FDA-ready treatment

For subscribers



Fujifilm Diosynth Biotechnologies' factory in Hillerød, Denmark. | Foto: Liselotte Plenov / Fotorummet / Pr
Pharma & biotech

Fujifilm expands management with former Leo executive

For subscribers



Foto: Andrew Kelly/Reuters/Ritzau Scanpix
Pharma & biotech

Low share price may knock Galecto off the stock exchange

For subscribers


Foto: Mike Segar/Reuters/Ritzau Scanpix
Pharma & biotech

Snack maker keeps an eye on Novo Nordisk's obesity drug


Foto: Yuriko Nakao/Reuters/Ritzau Scanpix
Medtech

Olympus appoints new chief medical officer

For subscribers


Foto: Alexander Heinl/AP/Ritzau Scanpix
Pharma & biotech

Novo Nordisk's semaglutide to be studied for positive effect on alcoholics

For subscribers


  • Vaccine breakthrough behind mRNA shots wins Nobel Prize

    The two scientists will share the 11 million-krona ( USD 1 million) award, the Nobel Assembly at the Karolinska Institutet in Stockholm said in a statement Monday.

    For subscribers


  • Foto: Ws Audiology / Pr

    WS Audiology hires new chief technology officer from car manufacturer

    He succeeds chief research & development officer Stefan Menzl, who is stepping down after six years.

    For subscribers


  • Foto: Tom Little

    Novo Nordisk files lawsuit against US authorities ahead of price negotiation

    The litigation is the latest in a long line of industry lawsuits related to price negotiations.

    For subscribers


  • Foto: Mike Segar

    FDA rejects atopic dermatitis drug lebrikizumab

    Eli Lilly had expected a launch this year.

    For subscribers


  • The FDA has updated the package label of Novo Nordisk's diabetes drug, Ozempic, with a warning about intestinal blockage disorder as a possible side effect. | Foto: Tom Little/Reuters/Ritzau Scanpix

    FDA updates Novo Nordisk's Ozempic drug label with side effect alert

    The diabetes drug might cause a potentially fatal intestinal blockage, the authorities warn.

    For subscribers


  • Foto: Anushree Fadnavis/Reuters/Ritzau Scanpix

    Country Manager: Indians will have to wait for Wegovy until 2026

    Up to 40% of the female population aged 30-49 in India is overweight.

    For subscribers


Further reading

Inadequate oversight of batch deviations and messy microbial controls are the cause of an FDA notice for a Novo Nordisk factory in the US, says media outlet Fiercepharma. | Foto: Novo Nordisk/pr
Pharma & biotech

Media: This is why the FDA has reprimanded Novo Nordisk following US plant inspection

Inadequate oversight of batch deviations and messy microbial controls are the cause of an FDA Form 483 for a Novo Nordisk plant in the US, reports media outlet Fierce Pharma.

For subscribers



Foto: Andrew Kelly
Pharma & biotech

FDA to support new orphan drugs through pilot program

Companies developing drugs for rare diseases can apply to be part of a new FDA pilot program, starting at the beginning of the year.

For subscribers



Søren Nielsen, CEO of hearing aid company Demant. | Photo: Demant / Pr
Hearing health

Jyske Bank questions Demant's continued momentum

With increasing competition in the hearing aid market, Jyske Bank analyst Janne Vincent Kjær does not expect Demant to continue its strong momentum into 2024.

For subscribers


Foto: Novo Nordisk/pr
Pharma & biotech

Media: Issues at Novo Nordisk factory have been known for more than a year

Already in May of last year, the FDA released a report documenting quality control failures at Novo Nordisk’s factory in Clayton, USA, Reuters reports. (Updated)

For subscribers



Scott Thomas Smith, CFO of Ascendis Pharma. | Foto: Ascendis Pharma / Pr
Pharma & biotech

Sale of royalties marks new approach to funding for Ascendis

Ascendis has historically raised capital through share issues, but that way of business is coming to an end.

For subscribers



Pharma & biotech

Bank downplays importance of patent dispute and FDA notice to Novo Nordisk

Neither problems at a US Novo Nordisk factory nor Viatris’ challenge of three of Novo’s patents related to the diabetes drug Ozempic change Barclays’ view on the stock.

For subscribers


Jobs

  • Supply Value Stream (SVS) Project Manager

  • Clinical Trial Manager

  • Senior Analytical Scientists

  • Senior Legal Councel

  • Senior CMC Specialist, Upstream Processing, Genmab

  • Senior QA Specialists (GMP or GCP)

  • VP of Software Development, Perfusion Tech

  • QA/RA Manager

  • Project Director, HR & ESG

  • Audit & Supplier Manager

  • Clinical Supply Manager

  • Scientist - Bioanalysis, Biologics

  • Director, Head of Antibody Technology

  • Global Medical Manager

  • Qualified Person to AJ Vaccines

See all jobs

Latest news

  • Novo Nordisk's semaglutide to be studied for positive effect on alcoholics –
  • Olympus appoints new chief medical officer –
  • Low share price may knock Galecto off the stock exchange –
  • Fujifilm expands management with former Leo executive –
  • Snack maker keeps an eye on Novo Nordisk's obesity drug –
  • FDA approves Novo Nordisk drug to treat rare condition –
  • FDA updates Novo Nordisk's Ozempic drug label with side effect alert –
  • FDA rejects atopic dermatitis drug lebrikizumab –
  • FDA to support new orphan drugs through pilot program –
  • Vaccine breakthrough behind mRNA shots wins Nobel Prize –
See all

Jobs

  • Supply Value Stream (SVS) Project Manager

  • Clinical Trial Manager

  • Senior Analytical Scientists

  • Senior Legal Councel

  • Senior CMC Specialist, Upstream Processing, Genmab

  • Senior QA Specialists (GMP or GCP)

  • VP of Software Development, Perfusion Tech

  • QA/RA Manager

  • Project Director, HR & ESG

  • Audit & Supplier Manager

  • Clinical Supply Manager

  • Scientist - Bioanalysis, Biologics

  • Director, Head of Antibody Technology

  • Global Medical Manager

  • Qualified Person to AJ Vaccines

See all jobs

Colophon

MedWatch
Search

Sections

  • Pharma & biotech
  • Medtech
  • Hearing health
  • Regulation
  • Other
  • Sitemap
  • RSS feeds

Editor

Mikkel Aabenhus Hemmingsen

mah@medwatch.dk

Tel.: +45 3330 8387

  • About MedWatch

Editor-in-chief

Anders Heering

Publisher

JP/Politiken Media Group Ltd

Banner Advertising

annoncering@infowatch.dk

Tel.: +45 7077 7441

Advertising

Job Advertising

job@infowatch.dk

Tel.: +45 7077 7441

Jobs

Subscription

Try MedWatch or get an offer for a subscription meeting the exact needs of you or your company.

medwatch@infowatch.dk

Tel.: +45 7077 7441

Learn more about subscriptions here

Address

MedWatch

Rådhuspladsen 37

1785 Copenhagen K, Denmark

Tel.: +45 3330 8370

Guidelines

  • Privacy Policy

Copyright © MedWatch — All rights reserved