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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

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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 “generic” drugs of the biopharma world. What is a Biosimilar?

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Public Comment to the WHO About Online Access to Imported Medicines and SDG 3.8

Pharmacy Checkers

Determinants of Health: Providing regulatory space to promote safe international Internet pharmacy practice in furtherance of SDG 3.8 the Internet, via international online pharmacies, has helped tens of millions of Americans obtain medicines from pharmacies in other countries. [v]. My comment is below. Author: Gabriel Levitt.

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A history of the pharmaceutical industry

pharmaphorum

The 21st century pharmaceutical and biotech sector has come a long way from its roots in 19th century pharmacy. Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids.

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Pricing, Profits and Progress: Pharma’s Post-COVID Priorities

pharmaphorum

Simply put, the revenues and profits from today’s mainstream drugs fund the scientific discovery that make tomorrow’s breakthrough drugs and critical vaccines possible. The truth about rising drug prices is more nuanced and merits exploration. The Big Misconception.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,