MedWatch

A part of Watch Media

Orphazyme to give oral explanation as EMA committee decision nears

Biotech company Orphazyme has been called in by the EMA’s expert committee, the CHMP, to answer questions concerning the company’s drug candidate, arimoclomol, on Wednesday at 4 pm. The same drug hope was quashed by the FDA last year.

The European Medicines Agency's headquarters in Amsterdam | Photo: Rob Acket/EMA
by CHRISTIAN BUNDGAARD, translated by daniel pedersen

At 16:00 CET on Wednesday Feb 23, 2022, Orphazyme will meet with the European Medicines Agency’s (EMA) special committee, the CHMP, to give a so-called ”oral explanation.”

The biotech company has been summoned by the EMA in connection with the approval process of Orphazyme’s biggest drug hope, its candidate arimoclomol, a potential treatment for neurodegenerative disease Niemann-Pick type C (NPC).

Already a subscriber? Log in.

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.

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
An error has occured. Please try again later.

Get full access for you and your coworkers.

Start a free company trial today

More from MedWatch

Britt Meelby Jensen wants to rebuild trust in Ambu

Britt Meelby Jensen, new CEO of Ambu | Foto: Novo Holdings / PR

After a turbulent time for Ambu under Juan Jose Gonzalez’s reign, new chief executive appointee Britt Meelby Jensen aims to rebuild the trust in the medtech firm, which has downgraded its expectations seven times over the past three years.

Outgoing Ambu CEO commends colleagues

Today, Juan Jose Gonzalez steps down from his role as chief executing of Ambu | Foto: Ambu/PR

”A true privilege,” says Juan Jose Gonzalez, describing his time as CEO at Ambu, which came to an end with Thursday’s announcement that Britt Meelby Jensen would take over the role.

Further reading

Related articles

Latest news

  1. Top news from MedWatch this week
  2. Outgoing Ambu CEO commends colleagues
  3. Nine new drugs recommended for approval by CHMP at May meeting
  4. Danish Medicines Council rejects Novartis breast cancer drug
  5. Analysts have great faith in incoming Ambu CEO
  6. Britt Meelby Jensen wants to rebuild trust in Ambu
  7. Ambu board had started headhunting process long before firing of CEO
  8. ALK CEO sells shares for USD 1.5m
  9. Novo Nordisk regains Novorapid supply capacity
  10. Ambu appoints Britt Meelby Jensen new CEO
  11. Zealand Pharma reports positive phase III results against congenital hyperinsulinism
  12. Audientes generates first-ever revenue in Q1
  13. Almirall and Evotec to collaborate on multiple severe skin disease targets
  14. Bavarian lands monkeypox vaccine contract with unnamed European country
  15. Thousands of collaborative research papers with China pose threat to Europe, authorities worry

See all

Job

See all jobs

See all jobs