Eliza Slawther

5 days ago | insights.citeline.com | Eliza Slawther

EU Pharma Reform: Lawyers Unpack Diverging Visions For InnovationThere 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.

1 week ago | insights.citeline.com | Eliza Slawther

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 OthersMadrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization. The European medicines agency has given the green light to 13 new products for marketing authorization in the EU (Shutterstock)

1 week ago | insights.citeline.com | Eliza Slawther

UK’s Decentralized Manufacturing Rules Designed To Allow ‘Future Developments’The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed. The MHRA is aware that its rules around decentralized manufacturing need to endure advancements in technology (Shutterstock)

1 week ago | insights.citeline.com | Eliza Slawther

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug RejectionIt appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns. The EMA is set to discuss matters relating to to re-examination of three products at its latest meeting (Shutterstock)

1 week ago | insights.citeline.com | Eliza Slawther

EU Decision Time For Madrigal’s MASH Drug Resmetirom & 11 OthersMadrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week. The CHMP is expected to deliver a verdict on the approval of 12 new drugs this week • Source: Shutterstock