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FDA Breakthrough Therapy Designation

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Havas Life London unveils AI awareness campaign

The campaign highlights the dangers of AI misinformation in rare disease

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FDA approves first gene therapy for Wiskott-Aldrich syndrome

Symptoms of the rare disease include bleeding, eczema and frequent infections

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Roche’s Columvi improves survival in large B-cell lymphoma

Approximately 160,000 people are diagnosed with this aggressive form of cancer each year

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Roche receives FDA clearance for whooping cough test

There are around 24.1 million cases of whooping cough annually, with around 170,000 deaths

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AstraZeneca announces $2bn investment in US manufacturing

The new and expanded facilities will support production of rare disease drug treatments

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AstraZeneca reports positive results from rare disease trial

HES is a group of rare disorders characterised by persistently elevated levels of white blood cells

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Genentech announces positive clinical results for BTK inhibitor MS treatment

Multiple sclerosis affects more than 2.9 million people globally

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Roche’s small cell lung cancer therapy approved by FDA

This is the first and only approved combination therapy for extensive-stage small cell lung cancer

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Roche’s Lunsumio receives positive CHMP opinion for follicular lymphoma

The recommendation for the subcutaneous formulation follows encouraging trial data

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Roche to acquire 89bio in a deal worth up to US$3.5bn

With the agreement, Roche will gain a treatment for moderate to severe MASH

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Genentech starts construction on manufacturing facility in North Carolina, US

The $700m project is part of Roche’s $50bn investment in the US

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Roche’s Evrysdi tablets approved by MHRA to treat spinal muscular atrophy

It is hoped the new formulation will offer patients greater freedom and flexibility compared to the liquid version

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