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AZ’s PNH therapy Ultomiris wins EU backing to expand use for children

The positive recommendation is based on interim results from a phase 3 trial

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Roche engaged in talks with FDA for Alzheimer’s drug candidate

CEO Severin Schwan told reporters Roche will complete a phase 3 trial of gantenerumab in the second half of 2022

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One dose of AZ’s COVID-19 vaccine ‘highly effective’ against severe disease from variants

New real-world data from Canada shows vaccine efficacy was lower against milder symptomatic disease with one dose

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Merck, Eisai’s Keytruda/Lenvima regimen scores full approval in endometrial cancer

Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process

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AZ licenses pneumonia mAb to Aridis Pharmaceuticals for $11m upfront

The candidate – suvratoxumab – is ready for phase 3 clinical evaluation for the prevention of pneumonia

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Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

In 2019, Bayer bought out its private equity partner Versant Ventures and founders in BlueRock Therapeutics for $240m

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Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery

The FDA had previously rejected a supplemental biologics licence application in this indication

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FDA advisory committee votes against approval of AZ, FibroGen’s roxadustat

Briefing documents published earlier this week raised questions over the safety profile of roxadustat

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Lilly and Banner Alzheimer’s Institute collaborate on donanemab prevention trial

Trial will evaluate donanemab in participants at risk for cognitive and functional decline related to Alzheimer’s

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AZ, J&J to research modifications to COVID-19 vaccines over rare blood clot issues

Researchers to explore potential of modifications to vaccine to reduce or remove risk of rare blood clots

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Eli Lilly to acquire Protomer Technologies in a deal worth over $1bn

Protomer Technologies is a US biotech company focused on engineering glucose-responsive insulin

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FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

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