The European Medicines Agency was this week due to consider requests from four companies that want it to fast-track its reviews of their planned EU drug marketing authorization applications (MAAs), including one from Eli Lilly for its Alzheimer’s disease drug candidate, donanemab.
EMA Deciding If Donanemab For Alzheimer’s & Three Other Drugs Merit Fast-Tracking
Eli Lilly, MSD, CLS and Pfizer could this week find out if the European Medicines Agency will agree that their planned EU marketing applications for donanemab, sotatercept, garadacimab and aztreonam-avibactam respectively deserve an accelerated assessment.

More from Europe
The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.
The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.
Cost and evidence gaps remain barriers for Kisunla and Leqembi as NICE rejects the drugs again but opens further consultations on the reimbursement of the Alzheimer's disease-modifying treatments.
The European Commission has confirmed that pharmaceutical companies will be able to request access to data for research under the new European Health Data Space Regulation, which has been published in the EU Official Journal and will enter into force on 26 March.
More from Geography
The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.
The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.