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BioWorld - Thursday, June 19, 2025
Home » Topics » Regulatory » Health Canada

Health Canada
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Woman at doctors office visit
Women's health

Abcellera gains Canadian clearance for phase I study of ABCL-635 for vasomotor symptoms in menopause

May 15, 2025
No Comments
Abcellera Biologics Inc. has received a no objection letter from Health Canada authorizing its clinical trial application (CTA) for ABCL-635.
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canada-court-regulatory.png

Health Canada jumps into PCCP filings for machine learning

March 4, 2025
By Mark McCarty
The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.
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Illustration of head with circuit board brain
HIF 2024

Neuralink just one part of ongoing BCI evolution

Nov. 26, 2024
By Marian (YoonJee) Chu
Fifty years after the term brain-computer interface (BCI) was coined, Neuralink and several other companies are reviving the promise of BCI for health care, as artificial intelligence and novel methods of neural signal detection work hand-in-hand to propel biomedical innovation.
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Liver over digital lens background

Organox gets greenlight in Canada for liver transplantation system

Oct. 4, 2024
By Shani Alexander
Organox Ltd. gained approval from Health Canada for its Metra system for use during liver transplantation. The system utilizes normothermic machine perfusion to maintain donor livers under physiologic conditions prior to transplantation.
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Gastrointestinal system with ulcerative colitis.
Gastrointestinal

Palisade submits CTA for PDE4 inhibitor prodrug for ulcerative colitis

Sep. 26, 2024
Palisade Bio Inc. has submitted a clinical trial application (CTA) for PALI-2108 for the treatment of ulcerative colitis, following a pre-CTA consultation meeting with Health Canada. Pending clearance, the company anticipates initiating a phase I study by year-end.
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Gears with regulatory words

Trio of regulators issues guidelines for transparency for AI

June 17, 2024
By Mark McCarty
For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.
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Canada continues to voice concerns about US drug imports

Jan. 17, 2024
By Mari Serebrov
The U.S. FDA’s Jan. 5 approval of Florida’s plan to import prescription drugs from Canada to take advantage of their lower price triggered ongoing communication between senior U.S. officials and Canada’s Ministry of Health over Canadian concerns about maintaining sufficient drug supplies.
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US FDA importation approval: Worth the wait?

Jan. 8, 2024
By Mari Serebrov
With its approval Jan. 5 of Florida’s drug importation program, the U.S. FDA ended a 23-year wait for the government to implement a 2000 provision allowing certain prescription drug imports from Canada.
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Canada launches new drug agency

Dec. 20, 2023
By Mari Serebrov
In an effort to standardize prescription practices across Canada, help Canadians afford their medicines and improve access to health data, the government is investing an additional $89.5 million over the next five years to establish the Canadian Drug Agency.
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Tumor microenvironment
Immuno-oncology

Ankyra Therapeutics receives clearance in US and Canada to advance its anchored immunotherapy agent into clinical trials

Oct. 25, 2023
Ankyra Therapeutics Inc. has received approval of its IND application by the FDA and its clinical trial application (CTA) by Health Canada for its lead agent, ANK-101, a novel tumor-directed anchored immune medicine.
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