Canada Archives - Medical Design Sourcing

Inside Canada’s approval of Amylyx’s ALS drug Albrioza

One of the things that differentiates amyotrophic lateral sclerosis (ALS) from other rare diseases is that “it is a catastrophic diagnosis,” said Chris Aiello, Head of Canada and General Manager, Amylyx Pharmaceuticals. “Patients do not really have much to go on in terms of pharmacological treatments.”

Last week, Amylyx Pharmaceuticals received Health Canada approval for the ALS therapy Albrioza (AMX0035) with conditions.

The regulatory nod represents the first approval for an ALS drug in recent memory.

A 2017 article in Frontiers in Aging Neuroscience noted that “the overwhelming majority” of human clinical trials for ALS drug candidates failed to show efficacy. Since 1980, there have been more than 80 randomized controlled trials in ALS, and only two therapies, riluzole and edaravone, have found widespread use.

Chris Aiello

“These patients …

Butterfly Network wins Canadian approval for next-gen handheld ultrasound

The Butterfly Network IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE: BFLY) announced today that Canada has approved its second-generation iQ+.

Butterfly Network touts the iQ+ features what the company describes as the world’s only Ultrasound-on-Chip technology, boasting hardware and software advances to improve usability and care delivery.

“We are excited that the Butterfly iQ+ will now be available for purchase by Canadian medical professionals,” said Butterfly Network CEO Dr. Todd Fruchterman. “Thousands of new practitioners and millions of patients will now have access to a transformative advanced assessment tool that can deliver valuable insights that enable more informed clinical decisions at the point of care.”

The IQ+ is now available in the United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland…

Sanofi to spend nearly $700M on new flu vaccine plant in Canada

[Photo from Unsplash]

Sanofi announced today that it will spend €600 million ($685 million) on a new plant in Toronto to produce its differentiated influenza vaccines.

The Paris-based pharma giant’s Fluzone high-dose quadrivalent influenza vaccine has four times more antigen than a standard-dose vaccine. The vaccine’s creators specifically designed it to provide superior protection against influenza for older adults.

The new plant will provide additional antigen and filling capacity for Fluzone, boosting supplies in Canada, the U.S. and Europe. The goal is to enhance preparedness for future influenza pandemics. While the present COVID-19 pandemic involves a novel coronavirus, influenza viruses have historically been a serious problem — most notably in 1918, which saw worldwide flu deaths in the millions.

Sanofi officials consider vaccines a key growth driver for the company in the fu…

Canada authorizes J&J’s COVID-19 vaccine

Photo by Hermes Rivera on Unsplash

Canada is hoping to accelerate its mass-vaccination program with the authorization of Johnson & Johnson’s COVID-19 vaccine, which the FDA also recently authorized.

Canada has now authorized four vaccines.

Pfizer has also agreed to ramp up deliveries to the country.

By the end of June, Canada could have 36.5 million vaccine doses. The country’s population is 37.9 million.

Ontario, the most densely populated province, also announced that it would allow the first and second doses of the Pfizer-BioNTech and Moderna vaccines to be administered with an up to four-month interval between doses.

The J&J vaccine currently requires only a single dose, although the company is testing a two-dose regimen.

Because the U.S. isn’t currently allowing domestically produced vaccines to be exported, Canada has relied on Europe and Asia to provide vacci…