Seeking Alpha

Vivus gives update on pursuit of centralized procedure for Qsymia EU approval

Vivus (VVUS-1.2%) updates investors on its European strategy for Qsymia. The company says it has submitted a request to the EMA for scientific advice on using a "pre-specified interim analysis from ...
Seeking Alpha

PolyPid Announces Eligibility for European Medicines Agency Centralized Procedure for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery

Centralized Procedure Allows for Submission of a Single Marketing Application to the European Medicines Agency that, if Approved, Would Allow D-PLEX 100 to be Marketed in All EU Member States D-PLEX ...
Nasdaq

Protalix Submits Marketing Authorization Application To EMA For PRX-102 For Fabry Disease Treatment

(RTTNews) - Protalix BioTherapeutics Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., announced the submission of a Marketing Authorization Application or MAA ...
RAPS

EMA Updates Guidance on Centralised Procedure

RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as ...
JD Supra

European Union to implement a unitary SPC and centralised examination procedure for SPCs

The European Commission has published its long awaited (and delayed) proposals for a substantial revision of the EU regulation on Supplementary Protection Certificates (“SPCs”), which wraps up a ...
JD Supra

EAASM Report on Patient Safety and Nanomedicines Calls for Centralized Regulatory Procedure

On September 17, 2020, the European Alliance for Access to Safe Medicines (EAASM) announced the availability of a report entitled Patient Safety and Nanomedicines: The need for a centralised ...