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Concerns Over PREVAIL Act Persist, Even With Amendment To Shield Off-Patent Drugs

The Bill Received A Close Vote Of 11-10 By The Senate Judiciary Committee

 
• By Urtė Fultinavičiūtė

Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.

US Senator Chris Coons
Chris Coons is one of the PREVAIL Act's lead sponsors (Shutterstock)

The controversial Promoting and Respecting Economically Vital American Innovation Leadership Act was finally voted by the Senate Judiciary Committee after the markup was postponed multiple times since the summer.

Also known as the PREVAIL Act (S.2220), the bill narrowly moved forward to the Senate floor for a full vote, receiving a vote of 11-10...

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Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

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Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
• By Urtė Fultinavičiūtė

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Fresenius Adds To Denosumab Competitors In Europe

 
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Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
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Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

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