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EU Health Chief Under Pressure To Explain Delay In Legislative Overhaul

 
• By Ian Schofield

The latest delay to the European Commission’s proposals for revising the EU medicines legislation has caused consternation among members of the European Parliament who do not believe that the hold-up is due simply to a “busy agenda” at the commission.

EU - Doctor
The EU wants to fix the ills of the pharmaceutical legislative framework • Source: Shutterstock

The EU health commissioner, Stella Kyriakides, attempted yesterday to convince skeptical members of the European Parliament (MEPs) that the oft-delayed package of proposals for revising the pharmaceutical legislation will actually be published on 26 April.

“I do want to confirm today that we are planning to adopt it on 26 April, so I am able...

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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

 
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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

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More from Geography

‘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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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.