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FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

 
• By Brenda Sandburg

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Patent skyline
The USPTO and FDA were advised on patent policy changes to prevent unjustified delays in competition • Source: Shutterstock

The US Food and Drug Administration should work with the US Patent and Trademark Office to verify information submitted for inclusion in the Orange Book is correct, a professor said at their joint public “listening session.”

S. Sean Tu, a professor at West Virginia University College of Law, focused on how the FDA and USPTO could...

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Sun Strikes Further US Price-Fixing Settlement For $200m

 
• By Dave Wallace

The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.

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.

US Federal Circuit Clears Path for MSN to Market Entresto Generic

 
• By Dean Rudge

Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Irish Ruling Gives Go-Ahead For Endo-Mallinckrodt Merger

 
• By Dave Wallace

A ruling from Ireland’s High Court has cleared the way for Endo and Mallinckrodt to consummate their merger in early August.

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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.

FDA Inspection Finds Leaks and Mold at Sun Pharma Halol Facility

 
• By Dean Rudge

Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.