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May 2023 Newsletter

Safe Biologics

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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May 2023 Newsletter

Safe Biologics

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth

Pharmaceutical Technology

YoY growth in revenue during the same period due to its robust pipeline, with Humira topping more than $20bn in sales in 2021, according to GlobalData’s Drugs Database. However, other challenges facing biopharmaceutical companies include growing generic drug competition, which places pressure on drug prices.

Vaccines 108
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Market outlook to 2032: future trends across the seven major markets

European Pharmaceutical Review

Insomnia market Dual orexin receptor antagonists (DORAs) [dual orexin receptor antagonists (DORAs)]… offer a new mechanism of action [in treating insomnia]” Across the seven major markets, the insomnia market is anticipated to grow at a compound annual growth rate (CAGR) of 2.6 percent from $3.2 billion in 2022 to $4.1

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. The primary manufacturer of a selected drug may also request CMS to terminate its agreement if they are unwilling to participate in the Medicare Drug Price Negotiation.

Labelling 105
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Three strategies for managing loss of exclusivity successfully

pharmaphorum

Drug prices to plummet in wave of expiring patents”. Price decay after loss of brand exclusivity”. These are just three headlines that come up when you Google “drug patent expiry”. Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. “Patent losses could sink Allergan”.