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Delivery systems for biologics

European Pharmaceutical Review

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Meeting rising demands of a new radiotheranostic era

European Pharmaceutical Review

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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mRNA therapeutics: a limitless revolution in medicine

European Pharmaceutical Review

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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First needle-free COVID-19 vaccine patch

European Pharmaceutical Review

Previous tests observed that the product remained stable and active when stored and transported at room temperature, due to its dry-coating technology. However, the new Phase I trial will gather data on its safety, tolerability and immunogenicity, as well as antibody and T-cell responses.

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The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Clarify Health

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

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The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Clarify Health

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

FDA 52