Blog
RSS FeedPosted by Michael Wonder on 12 Apr 2016
Updated new product assessment form and guidance
11 April 2016 - The SMC new product assessment form (NAPF) and guidance has been updated. ...
Posted by Michael Wonder on 04 Apr 2016
CADTH calls for patient input on submissions from Boehringer Ingelheim & Servier
4 April 2016 - CADTH has received notice of pending submissions from Boehringer Ingelheim for empagliflozin with metformin hydrochloride (Synjardy) for ...
Posted by Michael Wonder on 31 Mar 2016
Agenda for the 6 April 2016 TC meeting
31 March 2016 - The Transparency Commission will consider the reimbursement of pertuzumab (Perjeta), lixisenatide (Lyxumia), ezetimibe (Ezetrol) and secukinumab (Cosentyx). ...
Posted by Michael Wonder on 30 Mar 2016
Call for patient input on a submission from Boehringer Ingelheim for Jardiance (empagliflozin)
30 March 2016 - CADTH has received notice of a pending submission from Boehringer Ingelheim for empagliflizin (Jardiance) for use by ...
Posted by Michael Wonder on 25 Mar 2016
Introducing a common CADTH recommendation framework and establishing a minimum period of 120 calendar days for advance notification of anticipated submissions and resubmissions for CADTH Common Drug Review and pan-Canadian Oncology Drug Review Programs
23 March 2016 - CADTH will be implementing changes to the CDR Procedures and pCODR Procedures that will require all manufacturers/submitters ...
Posted by Michael Wonder on 24 Mar 2016
Pfizer announces European Medicines Agency accepted for review its marketing authorisation application for Xeljanz (tofacitinib citrate) for the treatment of moderate to severe rheumatoid arthritis
23 March 2016 - Pfizer announced today that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application ...
Posted by Michael Wonder on 24 Mar 2016
CADTH calls for patient input on a submission from Takeda for Entyvio (vedolizumab)
23 March 2016 - CADTH has received the following notice of a pending submission from Takeda for Entyvio (vedolizumab) for use ...
Posted by Michael Wonder on 23 Mar 2016
CADTH calls for patient input on a submission from Gilead for sofosbuvir with velpatasvir
23 March 2016 - CADTH has received notice of a pending submission from Gileda for sofosbuvir with velpatasvir for the treatment ...
Posted by Michael Wonder on 22 Mar 2016
Raptor's Procysbi new drug submission accepted by Health Canada with priority review
21 March 2016 - Raptor Pharmaceutical Corporation today announced that Health Canada has accepted for review its New Drug Submission for ...
Posted by Michael Wonder on 19 Mar 2016
Allergan confirms generic Abraxane patent challenge
17 March 2016 - Allergan today confirmed that it has filed an abbreviated new drug application with the U.S. FDA seeking ...
Posted by Michael Wonder on 19 Mar 2016
SMC announces more forthcoming submissions
18 March 2016 - The SMC has announced forthcoming submissions for the following medicines: carfilzomib (Kyprolis), dasatinib monohydrate (Sprycel), emtricitabine with ...
Posted by Michael Wonder on 17 Mar 2016
Call for patient input on a submission from UCB for brivaracetam
17 March 2016 - CADTH has received notice of a pending submission from UCB for brivaracetam for the treatment of patients ...
Posted by Michael Wonder on 11 Mar 2016
Call for patient input on a submission from Hospira for a subsequent entry biologic
11 March 2016 - CADTH has received notice of a pending submission from Hospira for Inflectra (infliximab) for the treatment of ...
Posted by Michael Wonder on 11 Mar 2016
Genmab announces submission of supplemental biologics license application to FDA for ofatumumab in combination with fludarabine and cyclophosphamide for relapsed CLL
10 March 2016 - The application was submitted by Novartis under the ofatumumab collaboration between Novartis and Genmab. ...
Posted by Michael Wonder on 11 Mar 2016
FDA accepts Amgen's supplemental biologics license application for the expanded use of Enbrel (Etanercept) to treat paediatric patients with chronic severe plaque psoriasis
10 March 2016 - Amgen today announced that the U.S. FDA has accepted for review Amgen's supplemental biologics license application for ...