Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food...more
On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...more
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....more
President Trump Announces Higher Tariff Rates Effective August 1st- After announcing an extension of the reciprocal tariff rates from July 9, 2025, to August 1,2025, President Trump published letters which were sent to...more
In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of...more
On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more
On May 28, 2025, the United States’ Court of International Trade (CIT) struck down the President’s use of the International Economic Emergency Powers Act (IEEPA) to impose tariffs. This includes tariffs imposed on Canada,...more
The evidentiary burden on plaintiffs to have a case certified—i.e., the “some basis in fact” standard—has been described as a “low bar” in countless cases. Plaintiffs cite the “low bar” in trying to certify their cases, and...more
In 2024, Ontario’s highest court affirmed the principle that a certifiable tort claim requires a plaintiff to provide some basis in fact for a present, materialized injury that is “sufficiently serious.” A legally compensable...more
The Supreme Court of Canada (SCC) has endorsed the constitutionality of British Columbia (BC) legislation empowering the province to seek recovery of opioid epidemic healthcare costs in a proposed class action brought on...more
The Bloom Burton & Co. Healthcare Investor Conference (BBHIC), held in Toronto this week, drew over 1,500 global participants to one of Canada's leading events for healthcare investment and innovation. The conference brought...more
Effective April 5, the United States imposed a 10% baseline tariff on imports from nearly all countries, excluding products from Canada and Mexico, and those products contained in the Harmonized Tariff Schedule of the United...more
On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more
This spring, the Supreme Court of Canada (SCC) will consider the scope of patentable subject-matter as it relates to “methods of medical treatment”....more
Since taking office in January 2025, the Trump Administration has announced, imposed, or reimposed various tariff-related restrictions on articles imported into the United States. These proposed tariffs and their...more
On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more
Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more
Antitrust authorities continue to make use of powers to scrutinize deals falling below merger control filing thresholds. Many that don’t have that ability, want it. The European Commission (EC) remains the frontrunner in...more
We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more
As we previously reported, JAMP sought leave to commence an application against Janssen under the abuse of dominance provisions of the Competition Act (the Act), relating to ustekinumab (Janssen’s STELARA and FINLIUS). This...more
2024 was an active year in Canadian patent law, with the Federal Court issuing several decisions on the merits regarding invalidity and/or infringement. The courts also considered issues of the regulation of patent agents,...more
On December 17, 2024, the Competition Tribunal (the Tribunal) issued reasons for its decision to dismiss an application for leave to bring a private abuse of dominance action against a major pharmaceutical manufacturer. JAMP...more
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more