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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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EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

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Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis

Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis

ECA webinar image

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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EMA orphan drug designation given to ReAlta for graft-versus-host disease therapy

This follows preliminary results from the company's ongoing phase 2 trial

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Takeda receives EC approval for Adcetris combination in Hodgkin lymphoma

The decision marks the second approval for an Adcetris-based regimen for front-line Hodgkin lymphoma

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Bristol Myers Squibb’s perioperative Opdivo regimen granted EC approval in NSCLC

Up to 55% of patients with non-metastatic NSCLC develop recurrence despite curative resection

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Bristol Myers Squibb’s injectable Opdivo formulation granted MHRA for solid tumours

The new formulation reduces administration time from 30-to-60 minutes to three-to-five minutes

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Takeda receives CHMP recommendation for Adcetris in Hodgkin lymphoma

The EC will review the committee’s positive opinion as it makes a decision on Adcetris in this indication

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BMS receives NICE recommendation for immunotherapy combination in colorectal cancer

Approximately 44,000 people are diagnosed with colorectal cancer in the UK every year

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BMS receives FDA approval for immunotherapy combination in liver cancer

Around 42,240 people are expected to be diagnosed with liver cancer in the US this year

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