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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 11 Aug 2016
Heart of bureaucratic darkness
9 August 2016 - Why won’t the FDA make a decision on a muscular dystrophy drug? ...
Posted by Michael Wonder on 11 Aug 2016
The future of cardiovascular medicine from the regulatory perspective
10 August 2016 - For many years, the American public and the entire world have benefited from the U.S. FDAs’ regulatory ...
Posted by Michael Wonder on 10 Aug 2016
Heron Therapeutics announces U.S. FDA approval of Sustol (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting
10 August 2016 - Sustol is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea ...
Posted by Michael Wonder on 10 Aug 2016
Cardiome announces Xydalba single dose infusion approval by European Medicines Agency
9 August 2016 - Cardiome Pharma Corporation has announced that Xydalba (dalbavancin hydrochloride) has been approved by the EMA for administration ...
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 09 Aug 2016
Australia's medicine labels are becoming clearer
9 August 2016 - Medicine labels provide important information about a medicine. Labels must clearly identify a particular medicine and provide ...
Posted by Michael Wonder on 09 Aug 2016
New treatment option for Canadians living with multiple myeloma
8 August 2016 - Takeda Canada receives approval for Ninlaro (ixazomib) - the first and only oral proteasome inhibitor providing a ...
Posted by Michael Wonder on 09 Aug 2016
Cancer-drug ads vs. cancer-drug reality
9 August 2016 - Two days into a long-dreamed-of family vacation to Italy in August 2013, my wife, Ronna, became nauseated, ...
Posted by Michael Wonder on 08 Aug 2016
New FDA documents reveal history of breakthrough therapy designation for Epclusa
5 August 2016 - Sofosbuvir with velpatasvir was originally granted fast track designation by the FDA on 30 September 2013 ...
Posted by Michael Wonder on 08 Aug 2016
EU collaboration strengthens safety monitoring of medicines
8 August 2016 - European Commission publishes three-year report on implementation of pharmacovigilance legislation. ...
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
The FDA approves first generic version of widely used influenza drug Tamiflu
On August 3, 2016, the U.S. FDA approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication ...
Posted by Michael Wonder on 06 Aug 2016
More on the transparency of public assessment reports in Europe and Australia
6 August 2016 - The TGA and EMA have recently described their experiences in publishing public assessment reports, and reflect ...
Posted by Michael Wonder on 05 Aug 2016
TGA publishes paper on transparency in medicines regulation
5 August 2016 - Co-authoring with the EMA, the TGA has published a peer-reviewed, free-to-view paper on transparency in medicines regulation. ...