Blog
RSS FeedPosted by Michael Wonder on 09 Mar 2016
Call for patient input on a submission from Merck for a subsequent entry biologic
9 March 2016 - CADTH has received notice of a pending submission from Merck for etanercept for use by certain patients ...
Posted by Michael Wonder on 08 Mar 2016
FDA accepts supplemental biologics license application for Keytruda (pembrolizumab) in advanced non-small cell lung cancer
8 March 2016 - The application is based on data from the Keynote-010 trial, which showed superior overall survival for ...
Posted by Michael Wonder on 03 Mar 2016
Baxalta submits marketing authorization application to the European Medicines Agency for Adynovi for treatment of haemophilia A patients
3 March 2016 - Currently marketed in the U.S. as Adynovate [Antihemophilic Factor (Recombinant), PEGylated], Adynovi is an innovative recombinant Factor ...
Posted by Michael Wonder on 01 Mar 2016
EUSA Pharma and AVEO announce submission of marketing authorization application for tivozanib in advanced renal cell carcinoma
1 March 2016 - EUSA Pharma and AVEO Oncology today announced the submission of a marketing authorization application to the EMA ...
Posted by Michael Wonder on 01 Mar 2016
Revised CADTH procedure for voluntary withdrawal of a submission
25 February 2016 - Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, manufacturers will have ...
Posted by Michael Wonder on 26 Feb 2016
EMA validates Gilead’s marketing application for tenofovir alafenamide fumarate (TAF) for the treatment of chronic hepatitis B
25 February 2016 - Gilead Sciences today announced that the company’s marketing authorization application for tenofovir alafenamide fumarate (TAF) 25 mg ...
Posted by Michael Wonder on 23 Feb 2016
PTC receives refuse to file letter from FDA for Translarna (ataluren)
23 February 2016 - The FDA states in the Refuse to File letter that the application was not sufficiently complete to ...
Posted by Michael Wonder on 17 Feb 2016
CADTH calls for patient input on a new submission from Eli Lilly for ixekizumab
17 February 2016 - CADTH has received notice of a pending submission from Eli Lilly for ixekizumab for the treatment of ...
Posted by Michael Wonder on 17 Feb 2016
CADTH calls for patient input on a new submission from Actelion for Uptravi
16 February 2016 - CADTH has received notice of a pending submission from Actelion for Uptravi (selexipag) for the treatment of ...
Posted by Michael Wonder on 06 Feb 2016
CADTH calls for patient input on submissions for 2 new medicines for use by patients with HIV infection
5 February 2016 - CADTH has received notice of pending submissions from Theratechnologies for Egrifta (tesamorelin acetate) for lipodystrophy in HIV-infected ...
Posted by Michael Wonder on 01 Feb 2016
CADTH calls for patient input on a new submission from Genzyme for Cerdelga
1 February 2016 - CADTH has received notice of a pending submission from Genzyme for Cerdelga (eliglustat tartrate) for the treatment ...
Posted by Michael Wonder on 21 Jan 2016
CADTH calls for patient input on two submissions from Novartis for Cosentyx
21 January 2016 - CADTH has received notice of pending submissions from Novartis for Cosentyx (secukinumab) for use by patients with ...
Posted by Michael Wonder on 18 Jan 2016
CADTH calls for patient input on a new submission from Celopharma for Mifegymiso
18 January 2016 - CADTH has received notice of a pending submission from Celopharma for Mifegymiso (mifepristone with misoprostol) for the ...
Posted by Michael Wonder on 16 Jan 2016
CADTH calls for patient input on a new submission from AstraZeneca for Brilinta
15 January 2016 - CADTH has received notice of a pending submission from AstraZeneca for ticagrelor (Brilinta) for the prevention of ...
Posted by Michael Wonder on 13 Jan 2016
SMC announces more forthcoming submissions
13 January 2016 - The SMC has announced forthcoming submissions for the following medicines: brivaracetum (Briviact), cabazitaxel (Jevtana), crizotinib (Xalkori), febuxostat ...