Canada

Returning to pulmonary hypertension, GSK buys 35Pharma

Tue, 03 Mar 2026 12:00:00 -0500

GSK plc is paying $950 million cash to acquire 100% of 35Pharma Inc.’s equity and pipeline, including phase II-ready candidate HS-235 for pulmonary hypertension. The acquisition agreement comes a day after GSK added two small interfering RNA assets from Nanjing, China-based Frontier Biotechnologies Inc. through a license deal reaching up to $1 billion.

Returning to pulmonary hypertension, GSK buys 35Pharma

Wed, 25 Feb 2026 12:00:00 -0500

So far, ACIP vaccine recommendations in line with the world

Thu, 02 Oct 2025 11:00:00 -0400

While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.

Health Canada vows to streamline operations for device, drug makers

Fri, 12 Sep 2025 12:00:00 -0400

Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.

In search of lower prices, FDA enhances Rx import program

Fri, 23 May 2025 11:00:00 -0400

It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices.

As tariffs threaten US imports of APIs, companies reshore manufacturing

Tue, 11 Mar 2025 12:00:00 -0400

While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.

As tariffs threaten US imports of APIs, companies reshore manufacturing

Mon, 10 Mar 2025 12:00:00 -0400

Speculations rise on US tariff impact on global pharma industry

Tue, 11 Feb 2025 12:00:00 -0500

For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.

Speculations rise on US tariff impact on global pharma industry

Fri, 07 Feb 2025 12:00:00 -0500

Medipost grows US, Canada base; plans US phase III of Cartistem

Tue, 21 Jan 2025 12:00:00 -0500

As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.

Medipost grows US, Canada base; plans US phase III of Cartistem

Wed, 15 Jan 2025 12:00:00 -0500

Pfizer notches another hemophilia approval

Mon, 14 Oct 2024 12:00:00 -0400

The U.S. FDA has approved the second hemophilia drug in nearly six months from Pfizer Inc. This one, Hympavzi (marstacimab), is for preventing or reducing bleeding in those age 12 and older with hemophilia A and B. Hympavzi heralds a couple of market boundary breakers: it’s the first and only anti-tissue factor pathway inhibitor approved in the U.S. for hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered using a pre-filled, auto-injector pen.

Wave View patenting microwave technology for pain-free, timely breast imaging

Mon, 29 Jul 2024 12:00:00 -0400

The first patenting to be published in the name of Wave View Imaging Inc. sees its co-founders file for additional protection of their imaging technology which can be used to monitor breast cancer treatment.

Trio of regulators issues guidelines for transparency for AI

Mon, 17 Jun 2024 12:00:00 -0400

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.

Usual players show up again in US trade report of bad actors

Tue, 21 May 2024 12:00:00 -0400

The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.

ANVISA to consider other regulatory decisions for device registration

Tue, 09 Apr 2024 12:00:00 -0400

While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices.

Amylyx pulling ALS drug Relyvrio from US, Canadian markets

Thu, 04 Apr 2024 12:00:00 -0400

Less than a month after disclosing that its confirmatory phase III trial of Relyvrio (sodium phenylbutyrate plus taurursodiol) fell short of its endpoint, Amylyx Pharmaceuticals Inc. is withdrawing the amyotrophic lateral sclerosis (ALS) drug from the market.

Canada continues to voice concerns about US drug imports

Wed, 17 Jan 2024 12:00:00 -0500

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.

US FDA importation approval: Worth the wait?

Mon, 08 Jan 2024 12:00:00 -0500

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.

Canada launches new drug agency

Wed, 20 Dec 2023 12:00:00 -0500

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.

Government groups team up on change control guiding principles

Tue, 24 Oct 2023 12:00:00 -0400

The U.S. FDA, Health Canada, and the U.K. Medicines and Healthcare Products Regulatory Agency have once again sidestepped the usual mechanisms for international regulatory cooperation to strike a blow for harmonization.

Haemonetics doesn’t skip a beat with $253M Opsens deal

Wed, 11 Oct 2023 12:00:00 -0400

Haemonetics Corp. returned to the M&A trail with an agreement to buy Opsens Inc., a cardiology-focused medical device company, for CA$2.90 (US$2.13) per share for a total of CA$345 million (US$253 million). The all-cash transaction, its third significant purchase in five years, is expected to close by late January 2024, pending the approval of regulators and 66.66% of voting shareholders. Haemonetics expects the deal to be immediately accretive to adjusted earnings per share (EPS).

Canada looks to Conscience for drug R&D

Tue, 10 Oct 2023 12:00:00 -0400

Hoping to find a niche where it can be a pacesetter in biopharma development, the Canadian government is investing CA$49 million (US$36 million) in the new Conscience Open Science Drug Discovery Network. The investment will be used to accelerate drug R&D “by leveraging Canadian strengths in artificial intelligence and employing open science principles to drive efficiencies in building Canadian innovation capacity and delivering the medicines that Canadians need,” François-Philippe Champagne, minister of Innovation, Science and Industry, said in announcing the funding Oct. 5.

Patent update: Total Flow designs cannulas for reducing ischemic conditions in cannulated limbs

Wed, 27 Sep 2023 12:00:00 -0400

The co-founder and CEO of Total Flow Medical Ltd, Hilary Pierce, reported the filing of a patent for bidirectional flow cannulas configured and designed to replace conventional femoral arterial cannulas for extracorporeal circulation during cardiopulmonary bypass procedures and that provide an optional dedicated blood flow to the ipsilateral limb.

Dexcom simplifies calorie and nutrient tracking with Rxfood partnership

Thu, 21 Sep 2023 12:00:00 -0400

Aiming to provide additional utility and information to its continuous glucose monitors (CGMs), Dexcom Inc. is tying in the nutrition information provided by Rxfood Corp.’s app for customers in Canada. Clinics, hospitals, pharmacies, health plans, employers and others can make the app available to the beneficiaries and patients who use the Dexcom G6 or G7 systems, once the program is rolled out.

Pepgen’s PGN-EDODM1 cleared to enter clinic in Canada for DM1, receives US orphan drug designation

Thu, 07 Sep 2023 09:00:00 -0400

Pepgen Inc. has received a no objection letter from Health Canada for its clinical trial application (CTA) to initiate a phase I study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). Initial data from the study are expected next year.

Painchek rolls out first AI-powered pain assessment solution in North America

Wed, 06 Sep 2023 12:00:00 -0400

People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence (AI) to identify the presence of pain even when it may not be obvious. This gives a voice to those who cannot verbalize pain, while also driving objectivity and consistency in pain assessments.

Recruitment underway for clinical study of PBM for treating long COVID-19

Mon, 21 Aug 2023 12:00:00 -0400

Recruitment underway for Toronto-based Vielight Inc. has commenced recruitment for a clinical trial in the U.S. to study how brain stimulation photobiomodulation (PBM) might mitigate long-term cognitive impairment from long Covid. The study intervention comes on the heels of Canadian approval of a device to treat the acute version of Covid, involving light emitting diodes (LEDs) placed inside the nasal cavity and on the chest to deliver near infrared (NIR) light to the body.

Light-activated compound possible answer to non-muscle invasive bladder cancer

Mon, 10 Jul 2023 12:00:00 -0400

Theralase Technologies Inc. has pioneered technology said to selectively infiltrate and kill non-muscle invasive bladder cancer (NMIBC) at the cellular level. Bladder cancer generally is the 10th most common cancer in the world (6th in men and 17th in women), and gradually showing up in greater numbers in other patient groups.

High bilirubin levels worsen stroke outcomes by aggravating brain damage

Wed, 15 Mar 2023 09:00:00 -0400

High levels of bilirubin exacerbated damage to neurons in the brain caused by a stroke by binding to the TRPM2 channel, which helped regulate cell death among other processes. The research, published March 14, 2023, in Neuron, showed that blocking the binding site for bilirubin in a mouse model led to improvements in neurotoxicity suggesting some potential for the development of new stroke therapeutics.