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PSCK9 Battle: Sanofi Not Negotiating Praluent Fate With Amgen; Ruling Possible By June

 
• By Brenda Sandburg

Sanofi attorneys describe three possible outcomes of fight over injunction and validity of Repatha patents, and contrast litigation to other patent disputes where innovators did not seek removal of innovator product from market.

Sanofi attorneys described three possible outcomes in their fight over the validity of Amgen Inc.’s Repatha (evolocumab) patents, saying that even if the US Court of Appeals for the Federal Circuit rules for Amgen, an injunction requiring them to withdraw their competing PCSK9 inhibitor Praluent (alirocumab) is “remote.”

During a Feb. 10 press call, the attorneys emphasized the “unprecedented” nature of the district court’s decision to grant a...

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New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
• By Eliza Slawther

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

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Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.