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Horizon 2020

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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

market access in Japan

Implementation of Cost-Effectiveness Analysis in Japan’s Health Technology Assessment Process

Japan’s evolving approach to market access includes a formal cost-effectiveness analysis (CEA) requirement for certain new medicines and medical devices. Introduced as part of a broader health technology assessment (HTA)...

Petauri Evidence

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Sanofi unveils $20bn US investment to boost R&D and manufacturing presence

The company is the latest major drugmaker to announce a significant investment in the country

Digital PI Compliance

Why Pharma’s Digital PI Compliance Problem Needs a Cross-Functional Fix

In many pharma teams, the responsibility for keeping prescribing information (PI) up to date online falls into a grey area. > Regulatory signs it off. > Marketing publishes it. >...

Genetic Digital

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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

Biogen Idec building

Biogen unveils plans for new global headquarters and R&D hub in US

The company is expecting to relocate its Cambridge-based employees to the new site in 2028

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AstraZeneca announces $2.5bn investment in China to boost R&D capabilities

The funds will go towards a new global research and development centre in Beijing’s BioPark

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