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Generic Priority Review Expanded In Senate User Fee Bill

 
• By Derrick Gingery

Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.

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Legislation expanding the US FDA's generic drug priority review pathway beyond sole-source drugs to generics entering markets with "limited competition" was added to the Senate's user fee reauthorization bill.

The Senate Health, Education, Labor and Pensions Committee overwhelmingly approved the amended FDA Reauthorization Act 21-2 on May 11, sending...

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• By Anju Ghangurde

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• By Dave Wallace

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Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
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UK Xtandi Patent Stands Strong As Accord, Sandoz, Teva Lose Appeal

 
• By Dean Rudge

The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.

Biocon Biologics ‘Strategically’ Expands Enbrel Biosimilar With A Launch In Australia

 
• By Urtė Fultinavičiūtė

After acquiring a solid biosimilars business from Viatris, Biocon Biologics has ticked off another market for its Nepexto (etanercept).

‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
• By Dave Wallace

At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.