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Dormant drug status can trigger generic access to an alternate Canadian Reference Product

Pharma in Brief

The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ).

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Top 40 Best-Selling Oncology Drugs in 2023 by 2022 Data

XTalks

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. mg capsules is $24,576.

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Top 40 Best-Selling Cancer Drugs in 2023 by 2022 Data

XTalks

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. mg capsules is $24,576.

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

XTalks

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. billion in pharmaceutical sales from 2021. billion, a 42.74

Sales 98
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PMPRB launches consultation on revised Draft Guidelines

Pharma in Brief

They include: (1) new factors for assessing excessive pricing, (2) new powers to collect information regarding these factors, (3) new obligations to report indirect price adjustments, (4) risk-based reporting obligations for OTC and generic drugs, and (5) a revised list of international price comparator countries (the PMPRB11 ).

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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. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Labelling.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.