Blog
RSS FeedPosted by Michael Wonder on 11 Aug 2016
FDA accepts Marathon Pharmaceuticals’ new drug applications for deflazacort for the treatment of Duchenne muscular dystrophy and grants priority review
10 August 2016 - Deflazacort could be among the first FDA approved treatments for this devastating genetic disorder. ...
Posted by Michael Wonder on 09 Aug 2016
EMA updates published list of new medicines under review by the CHMP
9 August 2016 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA has ...
Posted by Michael Wonder on 08 Aug 2016
Merck announces U.S. FDA filing acceptance of new drug application for MK-1293, an investigational follow-on biologic insulin glargine
5 August 2016 - Marketing authorization application to the European Medicines Agency currently under review. ...
Posted by Michael Wonder on 06 Aug 2016
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
5 August 2016 - The U.S. FDA today issued draft updated recommendations to help manufacturers determine when they are required to ...
Posted by Michael Wonder on 06 Aug 2016
CADTH calls for patient input on a submission from Cipher Pharmaceuticals for Actikerall (5-fluorouracil with salicylic acid)
5 August 2016 - CADTH is calling for patient input on a pending submission from Cipher Pharmaceuticals for Actikerall. ...
Posted by Michael Wonder on 05 Aug 2016
PBAC post-market reviews of chronic obstructive pulmonary disease medicines and ezetimibe
5 August 2016 - The public submission process is now closed. ...
Posted by Michael Wonder on 04 Aug 2016
PHARMAC updates its funding applications list
3 August 2016 - PHARMAC has published the funding applications received for PTAC for 2016. ...
Posted by Michael Wonder on 03 Aug 2016
CADTH calls for patient input on a submission from Horizon Pharmaceuticals for Ravicti (glycerol phenylbutyrate)
2 August 2016 - CADTH has called for patient input from Horizon Pharmaceuticals for Ravicti. ...
Posted by Michael Wonder on 03 Aug 2016
CADTH calls for patient input on submission from Allergan for Fetzima (levomilnacipran hydrochloride)
2 August 2016 - CADTH is calling for patient input on a pending submission from Allergan for Fetzima. ...
Posted by Michael Wonder on 02 Aug 2016
FDA accepts BLA for BioMarin's cerliponase alfa for CLN2 disease, form of Batten disease
27 July 2016 - Potential first treatment for fatal, rare, brain disease in children. ...
Posted by Michael Wonder on 01 Aug 2016
EMA to review marketing authorisation application for sarilumab
1 August 2016 - Sanofi and Regeneron Pharmaceuticals have announced the EMA has accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 27 Jul 2016
CADTH calls for patient input on submission from Pierre Fabre for Hemangiol (propranolol hydrochloride)
27 July 2016 - CADTH has received notice of a pending submission from Pierre Fabre for Hemangiol (propranolol hydrochloride). ...
Posted by Michael Wonder on 27 Jul 2016
FDA continues steady reduction of generic drug application backlog
25 July 2016 - As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US FDA ...
Posted by Michael Wonder on 22 Jul 2016
Merck provides regulatory update on biologics licensing application for investigational agent bezlotoxumab
22 July 2016 - Merck today said that the U.S. FDA has requested the submission of new data and analyses from ...
Posted by Michael Wonder on 22 Jul 2016
Mylan and Biocon announce regulatory submission for proposed biosimilar pegfilgrastim accepted for review by European Medicines Agency
21 July 2016 - Mylan and Biocon Ltd. announced today that the EMA has accepted for review, Mylan's marketing authorization application ...