Canada

Merck kicks off oral COVID-19 antiviral filing in Canada

Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results …

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Glaukos Expands its Partnership with Santen for Preserflo MicroShunt

Shots: The companies enter into a license agreement for the Preserflo MicroShunt superseding the previous collaboration between the two parties Glaukos get exclusive commercialization rights for the MicroShunt in the US, Australia, New Zealand, Canada, Brazil, Mexico and the remainder of Latin America and gain full control over all development activities for the MicroShunt in …

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Baltimore Vaccine Plant’s Troubles Ripple Across Africa, Europe and Canada

Millions of doses of Johnson & Johnson’s Covid-19 vaccine produced by Emergent BioSolutions have been held back in Europe, South Africa and Canada as a precaution.

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

AstraZeneca Vaccines Made at Troubled Baltimore Plant Were Shipped to Canada and Mexico

The Biden administration said it did not know of manufacturing problems at the Emergent factory when it approved shipping millions of doses of AstraZeneca’s vaccine. The company says the doses were safe.

Vaccines Made at Troubled Baltimore Plant Were Shipped to Canada and Mexico

The Biden administration said it did not know of manufacturing problems at the Emergent factory when it approved shipping millions of doses of AstraZeneca’s vaccine. The company says the doses were safe.

Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

Shots: Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases With the launch in Australia, Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada, and Australia Hadlima is Samsung Bioepis’ third anti-TNF biosimilar launched in Australia, following the launch of Brenzys (etanercept) and …

Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada Read More »

Canada suspends use of AstraZeneca Covid vaccine for those under 55

Immunisation panel says there is ‘substantial uncertainty about the benefit’ of the vaccine given risk of rare type of blood clot See all our coronavirus coverage Canada on Monday suspended the use of the Oxford/AstraZeneca coronavirus vaccine for people under 55 following concerns it might be linked to rare blood clots. The pause was recommended …

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Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

Shots: Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology Health Canada’s approval was based on analytical, pre/ clinical data that demonstrated similar PK, efficacy, safety and immunogenicity to the Humira. Idacio …

Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada Read More »

Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Shots: The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks. The therapy has shown similar …

Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis Read More »

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education …

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Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Shots: Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning The technology sustains performance for ~14days, providing trends, insights & actionable data …

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Drug importation from Canada won’t work

I’ve mentioned this in a number of previous posts, but large scale importation from Canada won’t work to bring down US drugs prices. The US market is too large and Canada does not have the supply to meet US demand. Further, policies proposing drug importation from Canada assume that Canadians will be passive actors in …

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Will everyone in the world have access to a Covid vaccine? – video explainer

The hunt for a coronavirus vaccine is showing promise but it is premature to say the end of the pandemic is nigh. Several rich countries have signed a ‘frenzy of deals’ that could prevent many poor nations from getting access to immunisation until at least 2024. Also, many drug firms are potentially refusing to waive patents and other intellectual property rights …

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Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are …

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19 Read More »

Novartis launches digital health hub in Canada

Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers. The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019. Canada is the latest country …

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Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Shots: Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells Luxturna is designed to provide functioning copies of the RPE65 gene to act …

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Read More »

FDA sets guidelines for drug importation from Canada

Last month, the US Food and Drug Administration published a final rule providing guidance for allowing drug importation from Canada. The drugs have to be approved by the Government of Canada’s Health Canada’s Health Products and Food Branch (HPFB) and can be imported by States or Indian Tribes, or in certain circumstances by pharmacists or …

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