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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Teresa Reguly ordered by Published Date Descending.
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1
Drug Price Cooling In Canada's Election Year: Release Of Final PMPRB Regulations
Final amendments to the Patented Medicines Regulations have been announced by the Government of Canada giving the Patented Medicine Prices Review Board
Canada
16 Aug 2019
2
Federal Court Of Appeal's Ruling On The Judicial Review Of PMPRB Decision On Differin
On June 28, the Federal Court of Appeal (FCA) affirmed the lower court's approach to patent review in determining whether the Patented Medicine Prices Review Board (PMPRB)
Canada
22 Jul 2019
3
PMPRB Decision Stands: Soliris Priced Excessively
The Federal Court has dismissed an application for judicial review by Alexion Pharmaceuticals Inc. (Alexion) in relation to a decision of the Patented Medicine Prices
Canada
8 Jul 2019
4
Simplifying Access To Unauthorized Drugs In Canada
The Canadian government has published proposed amendments to the Food and Drug Regulations (Regulations) that will improve access to unauthorized human drugs through the Special Access Program (SAP)
Canada
26 Jun 2019
5
Public Access To Clinical Information On Drugs And Medical Devices Granted
New regulations have been enacted by Health Canada to satisfy its objective of making clinical information in drug submissions and medical device applications ...
Canada
11 Apr 2019
6
Let Them Eat Cannabis – With Restrictions!
On December 22, 2018, the Canadian Federal Government published proposed regulations that will expand the permitted format for products that contain or are derived from cannabis.
Canada
8 Jan 2019
7
Federal Court Addresses The Intention And Application Of Vanessa's Law
The Federal Court of Canada has addressed how the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) ...
Canada
27 Jul 2018
8
Québec Government Limits Use Of Loyalty Cards And Patient Support In Draft Regulation
The Québec government's draft Regulation1 under the Act respecting prescription drug insurance (Act), concerning exceptions to the general prohibition on a manufacturer ...
Canada
24 Jul 2018
9
Le Gouvernement Du Québec Limite L'utilisation Des Programmes De Fidélisation Et De Soutien Aux Patients Dans Un Nouveau Projet De Règlement
Le projet de règlement du gouvernement du Québec1 édicté en vertu de la Loi sur l'assurance médicaments (la « Loi »), concernant les exceptions à l'interdiction générale pour un fabricant de couvrir ...
Canada
23 Jul 2018
10
Le Gouvernement Du Québec Limite L'utilisation Des Programmes De Fidélisation Et De Soutien Aux Patients Dans Un Nouveau Projet De Règlement
Le projet de règlement du gouvernement du Québec1 édicté en vertu de la Loi sur l'assurance médicaments (la « Loi ») ...
Canada
23 Jul 2018
11
Ontario Proposes Regulation Under "Sunshine" Law
Ontario is currently seeking feedback on its newly released proposed regulation under the "sunshine" legislation, the Health Sector Payment Transparency Act, 2017 (HSPTA).
Canada
7 Mar 2018
12
Alexion Pharmaceuticals V Canada FCA Dismisses Appeal Aimed At Constitutionality Of PMPRB Provisions
The Federal Court of Appeal's decision in Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2017 FCA 241 has significant implications for patentees ...
Canada
27 Dec 2017
13
Potential Change In Store For Regulating Disclosure Of Clinical Information
On December 9, the Government of Canada published proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (Regulations).
Canada
20 Dec 2017
14
Les Effets Du Projet De Loi 92 Sur Les Ententes Entre Les Fabricants Et Les Pharmacies Et Sur Le Soutien Aux Patients
Le 6 décembre 2016, l'Assemblée nationale du Québec a adopté le Projet de loi 92 intitule...
Canada
1 Feb 2017
15
The Impact Of Québec's Bill 92 On Arrangements Between Manufacturers And Pharmacies, And Patient Support
On December 6, 2016 the Québec National Assembly passed Bill 92, "An Act to extend the powers of the Régie de l'assurance maladie du Québec...
Canada
1 Feb 2017
16
The CADTH Releases Submission Guidelines For Biosimilars
The Canadian Agency for Drugs and Technologies in Health released Common Drug Review Procedure and Submission Guidelines for Subsequent Entry Biologics.
Canada
3 Apr 2014
17
Health Canada Releases Final Guidance On Subsequent Entry Biologics
Health Canada has released the final version of its guidance document Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) (Final Guidance), which is an update of the draft guidance released by Health Canada on January 30, 2008 and March 27, 2009 and applies to all pending and future drug submissions for SEBs in Canada.
Canada
17 Mar 2010
18
Biosimilars In Canada: New Draft Guidelines From Health Canada
Health Canada announced that it had granted marketing authorization for Omnitrope (a human growth hormone), the first subsequent entry biologic (SEB) to be approved for sale in Canada.
Canada
22 Jul 2009
19
Canada´s Regulation Of Subsequent Entry Biologics
Health Canada has released a revised version of the draft guidance document "Information and Submission Requirements for Subsequent Entry Biologics".
Canada
8 Apr 2009
20
Follow-On Biologics In Canada
Health Canada has released a draft guidance document entitled "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)."
Canada
3 Jun 2008
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