New method of cardiac ablation used in first in-human trial for ventricular tachycardia

Thermedical’s Durablate catheter [Photo courtesy of Thermedical]

A new cardiac ablation technique for patients with ventricular tachycardia (VT) has been used in its first in-human multicenter trial involving Mayo Clinic.

The new process — needle ablation using in-catheter, heated, saline-enhanced, radio frequency (SERF) energy — creates lesion scars inside the heart muscle where life-threatening arrhythmias cause VT, Mayo Clinic said. Injecting heated saline at the same time as the RF energy is applied increases heat transfer compared to conventional methods of ablation, which means the ablation can treat tissue deeper in the heart wall than the surface.

Caused by irregular electrical signals in the lower chambers of the heart, VT can trigger heartbeats so rapid that the heart’s chambers don’t fill with blood properly. VT can also stop the heart entirely. Implantable cardioverter-defib…

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Amylyx notches first global approval for oral ALS therapy Albrioza

Amylyx Pharmaceuticals (Nasdaq:AML) has received Health Canada approval for Albrioza (AMX0035).

The FDA is anticipated to decide on Albrioza, which consists of sodium phenylbutyrate and ursodoxicoltaurine, by September 29, 2022.

Amylyx is the first new therapy for ALS to win approval in Canada since 2018.

The approval also is the first global regulatory approval for the drug.

Health Canada decided to greenlight the drug after reviewing clinical trial data showing that it slowed disease progression and loss of functional decline in ALS patients.

“We are excited with Health Canada’s decision to approve Albrioza with conditions. Albrioza is a therapy that demonstrated in our CENTAUR trial a statistically significant and clinically meaningful impact on function, alone or in addition to existing ALS therapies,” said Justin Klee and Joshua Cohen, co-CEOs and co-founders of Amylyx, in prepared remarks. “We are grateful to the people who participat…

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Medicago and GSK win approval from Health Canada for adjuvanted plant-based COVID-19 vaccine

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine.

Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine. 

Known as Covifenz, the vaccine makes use of plant-based virus-like particles. 

The Health Canada approval covers adults between the ages of 18 to 64.

The agency approved the Novavax COVID-19 vaccine last week.

GSK is also working with K Bioscience in South Korea on an adjuvanted COVID-19 vaccine and with CureVac on a next-generation mRNA vaccine. 

“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect peopl…

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Health Canada authorizes AstraZeneca’s COVID-19 vaccine

[Photo by Praveen Kumar Nandagiri on Unsplash]

Health Canada today announced the authorization of the COVID-19 vaccine developed by AstraZeneca and Oxford University — the third vaccine for the novel coronavirus authorized in Canada.

“This is very encouraging news. It means more people vaccinated, and sooner. Because for AstraZeneca, just like we were for Pfizer and Moderna, we are ready to get doses rolling,” said Prime Minister Justin Trudeau, as recounted by CBC.

“Vaccines will keep arriving faster and faster as we head into the spring,” Trudeau said.

The Health Canada decision came after two studies — involving 11,636 participants in the U.K. and Brazil — showed an efficacy rate of 62.1% after two standard doses. The efficacy rate was 59.5% in an updated analysis in which the second dose was administered 4 to 12 weeks after the first dose.

On top of the AstraZe…

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Canada orders 37 million syringes from BD in anticipation of COVID-19 vaccine

Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine.

A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is ready for mass vaccinations if the cure for COVID-19 is discovered. There is no definitive timeline for the delivery of the syringes as of now.

Get the full story at our sister site, MassDevice.

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