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Article
Federal Court Approves Litigation Funding Agreement In Proposed Class Proceeding Against Generic Drug Manufacturers
As previously reported, a proposed class action proceeding against over 50 generic drug manufacturers was commenced in 2020.
CanadaFood, Drugs, Healthcare, Life Sciences
Smart & Biggar
Article
Federal Court Denies Stay Of Decision Issuing NOC For RUZURGI
On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc and KYE Pharmaceuticals Inc (collectively, the applicants) for an interlocutory injunction to stay the decision of the Minister of Health ...
CanadaFood, Drugs, Healthcare, Life Sciences

Smart & Biggar

Federal Court Dismisses Motion For A Fifth Generic To Be Added To Rivaroxaban Trial Of Common Issues Under PMNOC Regulations

The Federal Court had previously allowed a concurrent trial on common invalidity issues in actions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations)...

CanadaFood, Drugs, Healthcare, Life Sciences

Federal Court Of Appeal Dismisses Apotex's Appeal In Judicial Review Of Health Canada Decision Seeking Further Information From Facilities In India

The Federal Court of Appeal found that the application judge made no reviewable error in finding that the TPD's decision was not improperly motivated, and dismissed the appeal.

CanadaFood, Drugs, Healthcare, Life Sciences

Guidance Document - Use Of A Foreign-Sourced Reference Product As CRP

On November 27, 2017, Health Canada announced the release of Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product.

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada Announces Decision On Naming Of Biologic Drugs

As previously reported, Health Canada conducted stakeholder consultations and analysis of issues related to the naming of biologic drugs, including biosimilars.

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada Intends To Propose Post-Market Amendments To The Medical Devices Regulations

Health Canada intends to pre-publish the proposed regulatory amendments in 2019.

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada Posts 2023 To 2024 Review On Drug Shortages

On November 20, 2024, Health Canada posted Drug shortages in Canada: Fiscal year 2023 to 2024 in review. The review includes an overview of drug shortages...

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada Publishes Notice Of Consultation For Proposed Amendments To The Medical Devices Regulations

On January 7, 2022, Health Canada issued a notice of consultation for proposed amendments to the Medical Devices Regulations.

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada Publishes Updated Guidance Document On Classification Of Products At The Device-Drug Interface

On February 7, 2018, Health Canada published an update to the guidance document Classification of Products at the (Medical) Device-Drug Interface.

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada Requests Feedback If Company Names Were Added To The Generic Submissions Under Review List

The Generic Submissions Under Review (GSUR) list (previously reported) is a list of Abbreviated New Drug Submissions (generic submissions) ...

CanadaFood, Drugs, Healthcare, Life Sciences

Health Canada To Implement Further Pre-Market Transparency Initiatives For Prescription Drugs

Health Canada announced it will move forward with Phase III of its prescription drug product transparency initiatives.

CanadaFood, Drugs, Healthcare, Life Sciences

Minister Of Health Announces National Strategy For Drugs For Rare Diseases

On March 22, 2023, the Minister of Health announced the first-ever National Strategy for Drugs for Rare Diseases

CanadaFood, Drugs, Healthcare, Life Sciences

Minister Of Health Proposes Legislation For First Phase Of National Universal Pharmacare

On February 29, 2024, the Minister of Health announced the introduction of Bill C-64, An Act respecting pharmacare (Pharmacare Act), which "proposes the foundational principles...

CanadaFood, Drugs, Healthcare, Life Sciences

New Court Proceedings - October 2018

New Court Proceedings - October 2018

CanadaFood, Drugs, Healthcare, Life Sciences

Ontario Court Of Appeal Dismisses Appeal Of Judgment Awarding Apotex Damages From Contract Research Organization For Delayed FDA approval Of Two Products

As previously reported, in December 2017, Apotex was awarded over $11M in damages and pre-judgment interest for losses flowing from delays ...

CanadaFood, Drugs, Healthcare, Life Sciences

Patented Medicines Regulations: The Problem Is Not In Collecting The Data, But In How You Use It! (June, 2023)

The Federal Court of Appeal recently heard a constitutional challenge to the new Patented Medicines Regulations that came into force on July 1, 2022.

CanadaFood, Drugs, Healthcare, Life Sciences

PMPRB News: Amendments Still Not Released; Alexion/SOLIRIS, Galderma/DIFFERIN Decisions

While originally proposed to come into force on January 1, 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of June 30

CanadaFood, Drugs, Healthcare, Life Sciences

Potential Pan-Canadian Formulary: Discussion Paper And Online Questionnaire

CADTH has provided an online questionnaire for stakeholders to provide feedback; the online consultation period will run through to February 25, 2022.

CanadaFood, Drugs, Healthcare, Life Sciences

Quebec Court Of Appeal Overturns Minister's Decision To Delist REMICADE From Quebec's List Of Medications

This appeal arose in the context of a February 15, 2017 decision of the Minister of Health and Social Services (the "Minister") to halt coverage of Janssen's REMICADE ...

CanadaFood, Drugs, Healthcare, Life Sciences

Showing 181–200 of 2490 results

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