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RSS FeedPosted by Michael Wonder on 10 Jan 2017
Australian approval for drug that 'melts' leukaemia
10 January 2017 - A new anti-cancer drug with the power to ‘melt away’ certain advanced forms of chronic lymphocytic ...
Posted by Michael Wonder on 09 Jan 2017
Afstyla (rFVIII) for haemophilia A, receives European Commission approval
9 January 2017 - CSL today announced that the European Commission has granted marketing authorisation for CSL Behring’s Afstylta [recombinant ...
Posted by Michael Wonder on 09 Jan 2017
BioCryst receives Health Canada approval for Rapivab for the treatment of influenza
8 January 2017 - BioCryst Pharmaceuticals today announced that Health Canada has approved Rapivab (peramivir injection), an intravenous treatment for ...
Posted by Michael Wonder on 06 Jan 2017
German IQWiG confirms additional benefit for Kisplyx (lenvatinib mesylate) in combination with everolimus for the treatment of advanced renal cell carcinoma
4 January 2017 - Approximately 15,000 people in Germany develop renal cell carcinoma every year. ...
Posted by Michael Wonder on 06 Jan 2017
FDA approves Genentech’s Lucentis (ranibizumab) for myopic choroidal neovascularisation
5 January 2017 - Granted priority review by the FDA. ...
Posted by Michael Wonder on 05 Jan 2017
New FDA drug approvals: breaking down the numbers
4 January 2017 - If a decline in FDA approvals of new pharmaceuticals is a bad sign for the industry, ...
Posted by Michael Wonder on 05 Jan 2017
Health Canada approves Orfadin capsules for treatment of hereditary tyrosinaemia type-1
4 January 2017 - Orfadin to be available in a range of dosing alternatives, including first ever 20 mg dosage. ...
Posted by Michael Wonder on 04 Jan 2017
A review of CDER’s novel drug approvals for 2016
4 January 2017 - This past year was another successful year for the new drugs program in FDA’s Center for Drug ...
Posted by Michael Wonder on 04 Jan 2017
U.S. FDA approves supplemental new drug applications to include landmark data in product labels for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets
4 January 2017 - The U.S. FDA approved supplemental new drug applications for three type 2 diabetes medicines within the empagliflozin ...
Posted by Michael Wonder on 03 Jan 2017
2016 in review
4 January 2017 - The PBAC considered 192 submissions in 2016; 193 were considered by the Committee in 2015. ...
Posted by Michael Wonder on 03 Jan 2017
The NICE year in review
3 January 2017 - NICE has reflected on some of the news over the past twelve months. ...
Posted by Michael Wonder on 03 Jan 2017
NICE says liver cancer treatment to stay within the Cancer Drugs Fund, but not recommended for routine NHS use
30 December 2016 - The drug, sorafenib tosylate (Nexavar), which is used for treating advanced hepatocellular carcinoma, is not value for ...
Posted by Michael Wonder on 03 Jan 2017
Two key FDA decisions to watch out for in January 2017
2 January 2017 - The drug development process is often lengthy and time-consuming and requires the utilisation of a lot ...
Posted by Michael Wonder on 02 Jan 2017
New drug approvals fall to six-year low in 2016
2 January 2017 - Last year turned out to be a disappointing one for new drug approvals with the U.S. ...
Posted by Michael Wonder on 31 Dec 2016
Breast cancer drug rejected for NHS use on cost-benefit grounds
29 December 2016 - Charities angered by guidance on Kadcyla, which costs £90,000 per year per patient and gives extra nine ...