article thumbnail

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 ).

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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 ).

article thumbnail

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

Pharma in Brief

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. Labelling.

article thumbnail

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.

article thumbnail

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.

article thumbnail

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

XTalks

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. The company is comprised of several units, and the largest is Johnson & Johnson’s pharma unit which generated $52.56 billion in pharmaceutical sales from 2021. billion the drug generated in 2021. billion, a 42.74

Sales 98