Blog
RSS FeedPosted by Michael Wonder on 17 Feb 2022
Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
17 February 2022 - Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial ...
Posted by Michael Wonder on 25 May 2021
European Medicines Agency grants BioMarin's request for accelerated assessment of valoctocogene roxaparvovec for treatment of severe haemophilia A
24 May 2021 - MAA resubmission on track for June 2021. ...
Posted by Michael Wonder on 27 Apr 2021
EMA grants accelerated assessment procedure for Nefecon for the treatment of IgA nephropathy
23 April 2021 - Calliditas Therapeutics today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation ...
Posted by Michael Wonder on 01 Apr 2019
OncoSec announces advanced therapy medicinal product classification from the EMA for TAVO in refractory metastatic melanoma
1 April 2019 - Classification as an ATMP Positions TAVO for accelerated review and approval in Europe. ...
Posted by Michael Wonder on 19 Jun 2017
Accelerated assessment of medical devices - priority review pathway
19 June 2017 - The TGA sought comments from interested parties on the consultation paper for accelerated assessment of medical devices ...
Posted by Michael Wonder on 17 Mar 2017
Expedited pathways for prescription medicines
17 March 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
Posted by Michael Wonder on 02 Mar 2017
Alnylam receives European Medicines Agency PRIME designation for accelerated assessment of givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias
1 March 2017 - Alnylam Pharmaceuticals announced today that the EMA has granted access to its Priority Medicines (PRIME) scheme ...
Posted by Michael Wonder on 24 Jan 2017
European Medicines Agency grants accelerated assessment, validates marketing authorisation application for AbbVie's investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
24 January 2017 - Marketing authorisation application is supported by data from global registrational clinical development program across all major ...
Posted by Michael Wonder on 21 Sep 2016
Recommendations on eligibility to PRIME scheme
21 September 2016 - During its September 2016 meeting, the CHMP reviewed 9 recommendations for eligibility to PRIME: 2 were ...
Posted by Michael Wonder on 04 May 2016
BioMarin announces EMA grants accelerated assessment for cerliponase alfa, experimental treatment for a form of Batten disease
3 May 2016 - BioMarin today announced that the EMA has granted BioMarin's request for accelerated assessment for the planned cerliponase ...
Posted by Michael Wonder on 01 Apr 2016
New treatment for patients with multiple myeloma
1 April 2016 - The EMA has recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of adults ...
Posted by Michael Wonder on 30 Jan 2016
EMA fast-tracks treatment of multiple myeloma for approval in EU
29 January 2016 - Empliciti is a monoclonal antibody that works by activating the body’s immune system to attack and kill ...
Posted by Michael Wonder on 20 Jan 2016
From our perspective: Expedited oncology drug approvals
19 January 2016 - Richard Pazdur, M.D., Director of the FDA's Office of Hematology and Oncology Products, highlights some of his ...