Biotech company Orphazyme has decided to withdraw its European marketing authorization application for its drug hope, arimoclomol, a potential treatment for Niemann-Pick type C (NPC), a company press release reports.
This falls before the European Medicines Agency’s (EMA) special committee, the CHMP, was slated to vote officially on whether to recommend the drug for approval later this month. Based on a trend vote following a February meeting with the committee, Orphazyme was not expecting the drug to be approved.
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
Get full access for you and your coworkers.
Start a free company trial todayMore from MedWatch
Long wait for IVDR implementation is over, putting an end to pandemic "wild west"
After prolonged debates on potential bottlenecking and supply issues, the EU’s long-awaited In Vitro Diagnostic Medical Devices Regulation comes into force on May 26.
GN purchase story is very speculative, says analyst
Competition rules could block a purchase of GN Store Nord and subsequent divestment of GN Hearing, says a Sydbank analyst on the speculative story that this might be underway.
Bavarian Nordic upgrades guidance following vaccine contract
Bavarian has been the center of attention in recent days due to its monkeypox vaccine, and the company has now secured a vaccine contract with another undisclosed country. Consequently, Bavarian has raised its expectations for the full year.
Novo Nordisk invests additional millions of dollars in new manufacturing facilities
Novo Nordisk’s DKK 17bn (USD 2.4bn) investment into upgrading and building new facilities in Kalundborg last year has now been followed by a DKK 1bn (USD 143.8m) investment in the same location.
US to start using Bavarian vaccine stockpile
In an attempt to contain a monkeypox outbreak, US authorities will start offering certain people Bavarian Nordic-developed Jynneos vaccinations against the infectious disease.
Scientific Writer 
Clinical Project Manager 
Innovation Project Manager, Display Unit 
Analytical Senior Scientist 
Production Director 
Senior Project Manager (GMP - Life Science) 
CMO Operations Specialist - screening & selection of CMO/CDMO’s 
Clinical Trial Administrator 
Client Talent Acquisition Specialist 
IRT Manager, Clinical Drug Supply 
Key Account Manager, Europe and Asia 
Account Manager 
Senior Chemical Safety Advisor 
KLIFO is looking for a Clinical Supply Manager for our Glostrup office 
Communications Consultant 
Director Global Engineering 
Chemist for Incoming Materials in QC Department