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From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

Federal Court of Appeal dismisses Pfizer’s appeal of interlocutory decision in pregabalin section 8 case: infringement not a...

UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150)... As previously reported, Justice O’Reilly of the Federal Court granted Pharmascience’s...more

Rebate Update: Amendments to Ontario Regulations remove cap on Ordinary Commercial Term Benefits and restrictions on Private Label...

In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more

Seedlings’ LifeCard patent found invalid and not infringed by Pfizer’s EpiPen

Update: On July 28, 2021, the Federal Court of Appeal dismissed Seedling’s appeal from Justice Grammond’s decision: Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154 (see article here). On January 2,...more

Proposed amendments to Ontario Regulations to streamline administrative process, change OCT payment limit, and reduce government...

On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more

Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

Court dismisses Allergan’s judicial review application of Alberta Minister of Health’s bimatoprost interchangeability designation

On August 8, 2019, the Court of Queen’s Bench of Alberta dismissed Allergan’s application for judicial review of a decision by the Alberta Minister of Health (the Minister) to designate Allergan’s glaucoma treatment product...more

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