Private: Gallery Post #1

29

May2014
The Federal Court (Justice O’Reilly) issued decisions May 27 in two similar cases (Sandoz 2014 FC 501 and Ratiopharm 2014 FC 502) and concluded that generics firms that market generic products (even under a licencing agreement from the patent holder) are not patentees for purposes of PMPRB price regulation so ... Read More

27

May2014
On February 11, 2014, the pan-Canadian Oncology Drug Review (pCODR) invited stakeholder comments on proposed changes to the pCODR Procedures and related guidance documents.A summary of the stakeholder feedback can be found here.  In view of the stakeholder comments, effective June 1, 2014, pCODR will no longer ... Read More

26

May2014
CDR Consultation – Patient Input Template for Subsequent Entry Biologics (SEB) CADTH has developed a patient input template for SEBs and is now seeking feedback on the proposed template. Feedback should be emailed by June 6, 2014 to feedback@cadth.ca. Temporary Suspension of a CDR Review Due to Incomplete Information CADTH has recently encountered CDR submissions with ... Read More

25

May2014
Invitation to attend PMPRB Outreach sessions Board Staff will be conducting training sessions regarding the online tool for the filing of the Form 2 information starting for the upcoming January to June 2014 filing. The sessions will be given as follows: Montreal: Wednesday June 11, 2014 from 1:00 p.m. to ... Read More

24

May2014
Common Drug Review (CDR) introduces new application fee for submissions The Canadian Agency for Drugs and Technologies in Health (CADTH) is introducing an industry application fee for submissions made by drug manufacturers to CDR effective September 1, 2014 (April 1, 2015 for drugs submitted to the pan-Canadian Oncology Drug Review). All submissions with a ... Read More

23

May2014
Note worthy news featured in this edition include: Anna Chodos and Beatrice Mullington retire Final requirements for HDAP submissions Online Filing of Form 2 - Project Update CPI-Based Price-Adjustment Factors for 2015 The Hearing Panel approved a VCU in the Teva Canada Innovation G.P-S.E.N.C. and the medicine Copaxone matter New Publication - NPDUIS Research ... Read More

23

May2014
The Institut national d’excellence en santé et en services sociaux (INESSS) has released its list of drugs under review for the October 2014 Liste de médicaments. Comments from health professional groups and associations regarding these drugs can be sent to INESSS by May 30th, ... Read More

22

May2014
CDEC will review and provide recommendations on reimbursement of drugs for rare diseases (DRDs) according to an enhanced Common Drug Review approach, as per news released today in CDR Update- Issue 103. CADTH incorporated suggestions from stakeholder feedback (invited in October ... Read More

18

Feb2014
Statistic Canada has released the final Consumer Price Index (CPI) figure for 2013 with full year annual inflation as measured by CPI increasing by 0.9% over 2012. For PMPRB price compliance, this is important for two reasons. First, this is the second year running ... Read More

18

Feb2014
Yesterday marked the beginning of the second phase of the provincial government’s generic drug pricing policy in Newfoundland and Labrador. Generic drugs will now be priced at no more than 40% of the brand price.  The province has also now finalized an agreement with the Pharmacists’ Association of Newfoundland and ... Read More