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EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

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BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma

This type of cancer is the most common one diagnosed in teenagers

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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

- PMLiVE

EU medicine shortages hit record highs in 2023 and 2024

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

- PMLiVE

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

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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

- PMLiVE

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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