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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent. Biologic Drugs.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.”

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir.

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. While small molecule drugs can be remade into identical generics, biologics are more complex. For example, the first-to-market status was beneficial when it came to insulin biosimilars.

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