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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Globalisation and supply chain complexity are a factor.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU. Christophe Vaessen. STeP participation does not imply product authorization.

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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval. Patel et al.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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Three biggest threats to healthcare

World of DTC Marketing

According to a new Survivor Views survey from the American Cancer Society Cancer Action Network (ACS CAN), a majority of patients and survivors say they were unprepared for the costs of their care both in terms of their ability to pay for it (54%) and in what they thought it would cost (64%). Launch prices of new cancer drugs in the U.S.