Blog
RSS FeedPosted by Michael Wonder on 11 Jun 2016
CADTH calls for patient input on submission from Teva for Fentora (fentanyl citrate)
10 June 2016 - CADTH calls for patient input on a submission from Teva Pharmaceuticals for Fentora (fentanyl citrate). ...
Posted by Michael Wonder on 08 Jun 2016
CADTH calls for patient input on submissions from Daiichi Sankyo for edoxaban tosylate
8 June 2016 - CADTH has received notice of pending submissions from Daiichi Sankyo for edoxaban tosylate. ...
Posted by Michael Wonder on 01 Jun 2016
BioMarin to stop developing current drugs for Duchenne muscular dystrophy
31 May 2016 - US health regulators rejected company’s Kyndrisa treatment in January. ...
Posted by Michael Wonder on 24 May 2016
Samsung targets US drug market with Remicade knockoff
24 May 2016 - Affiliate Samsung Bioepis says its biosimilar of the arthritis drug is being reviewed by the FDA. ...
Posted by Michael Wonder on 24 May 2016
Sandoz' biosimilar rituximab regulatory submission accepted by European Medicines Agency
24 May 2016 - Sandoz is seeking approval for all indications included in the reference product's label. ...
Posted by Michael Wonder on 20 May 2016
Pfizer announces European Medicines Agency acceptance for review of marketing authorization application for Trumenba (meningococcal group B vaccine)
20 May 2016 - Pfizer today announced the EMA has accepted the Marketing Authorization Application for Trumenba (Meningococcal Group B Vaccine) ...
Posted by Michael Wonder on 18 May 2016
Novo Nordisk files for regulatory approval in the US of long-acting factor IX for the treatment of haemophilia B
16 May 2016 - Novo Nordisk today announced the submission to the US FDA of the Biologics License Application for the ...
Posted by Michael Wonder on 17 May 2016
Call for patient input on a submission from Boehringer Ingelheim for Praxbind
17 May 2016 - CADTH has received notice of a pending submission from Boehringer Ingelheim for Praxbind (idarucizumab) for the reversal ...
Posted by Michael Wonder on 07 May 2016
Pharmaceutical Benefits Advisory Committee Guidelines review
6 May 2016 - The public consultation processes on the draft revised PBAC Guidelines (Version 5.0) and the assessment of co-dependent ...
Posted by Michael Wonder on 04 May 2016
Call for patient input on a submission from Teva Pharmaceuticals for reslizumab
4 May 2016 - CADTH has received notice of a pending submission from Teva Pharmaceuticals for reslizumab for use by patients ...
Posted by Michael Wonder on 02 May 2016
Call for patient input on a submission from Raptor Pharmaceutical for Quinsair (levofloxacin hemihydrate)
2 May 2016 - CADTH has received notice of a pending submission from Raptor Pharmaceutical for Quinsair (levofloxacin hemihydrate) oral solution ...
Posted by Michael Wonder on 26 Apr 2016
Call for patient input on a submission from Ferring Pharmaceuticals for budesonide
26 April 2016 - CADTH has received notice of a pending submission from Ferring Pharmaceuticals for budesonide for use by patients ...
Posted by Michael Wonder on 21 Apr 2016
Patient group submissions to the SMC
21 April 2016 - The SMC has developed two short films to help explain how the agency works with patient groups ...
Posted by Michael Wonder on 14 Apr 2016
SMC announces more forthcoming submissions
14 April 2016 - The SMC has announced forthcoming submissions for the following medicines: aflibercept (Eylea), alirocumab (Praluent), budesonide (Cortiment), diamorphine ...
Posted by Michael Wonder on 13 Apr 2016
Merck announces FDA acceptance of biologics license application for investigational house dust mite sublingual allergy immunotherapy tablet
12 April 2016 - Merck today announced that the U.S. FDA has accepted for review the Biologics License Application (BLA) for ...