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Lilly announces plan for new $3bn facility to boost manufacturing in Europe

The facility will be built in the Netherlands and will increase capacity for the company's oral medicines portfolio

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EU medicine shortages hit record highs in 2023 and 2024

Even with countermeasures in place, European auditors warn that the risks remain elevated

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ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs

On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation...

Genesis Research Group

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J&J’s Darzalex recommended by CHMP to treat smouldering multiple myeloma

If approved, Darzalex would be the first therapy approved in the EU for SMM

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Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

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Rare diseases: Novartis’ Fabhalta recommended by CHMP for C3 glomerulopathy

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year

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Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa

There is currently only one treatment authorised for the ultra-rare genetic blistering disease

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CHMP recommends Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

Approximately 480,000 cases of the mosquito-borne viral disease were reported globally in 2024

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Gilead’s seladelpar recommended by CHMP to treat primary biliary cholangitis

The rare liver disease affects approximately 15 per 100,000 people in Europe

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GSK’s Jemperli receives positive CHMP opinion for expanded endometrial cancer use

Approximately 121,000 people are diagnosed with primary advanced or recurrent endometrial cancer each year in Europe

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MHRA urges companies to prepare for Windsor Framework for medicines

The new UK-wide arrangements for medicines will come into effect on 1 January 2025

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Biogen/Eisai’s Alzheimer’s drug lecanemab receives CHMP recommendation

The neurodegenerative disorder affects an estimated 6.9 million people in Europe

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