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Hereditary Angioedema Patients Urge Work On Dosing, Product Shortages

 
• By Kate Rawson

US FDA's final patient-focused drug development meeting shows high interest clinical trial enrollment.

Hereditary angioedema patients used the final US FDA-hosted patient-focused drug development meeting to advocate for the development of additional treatment options for HAE, citing intermittent manufacturing supply issues with existing biologics and the lack of a treatment that sufficiently prevents or controls body swelling episodes.

HAE is a rare genetic disorder that is associated with painful episodic, recurrent attacks of body swelling caused by abnormalities in the C1-esterase inhibitor protein. Most cases occur because there...

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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

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