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Q3 results

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FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

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FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

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Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

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PM announces plans to lift England’s COVID-19 restrictions

Following the announcement, England is set to remove its ‘Plan B’ COVID-19 restrictions over the next week

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AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

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Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients

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BioNTech and InstaDeep collaboration develops SARS-CoV-2 Early Warning System

Following a successful development and testing programme, the computational system is able to predict high-risk variants of SARS-CoV-2

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AstraZeneca’s Vaxzevria trial provides further support for protection against COVID-19 variants

New data from continued testing has shown that a third booster of Vaxzevria supports an increased antibody response against SARS-CoV-2 variants

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Pfizer CEO announces plans to launch Omicron-specific COVID-19 vaccine

Bourla was speaking in response to questioning during a healthcare conference as to whether a new jab would be needed to protect against Omicron

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Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

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UK marks one-year anniversary of Oxford/AstraZeneca vaccine

The at-cost vaccine produced in the UK has been administered worldwide

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J&J’s COVID-19 booster shows 85% effectiveness in preventing hospitalisation for COVID-19 in study

The Sisonke study was done in South Africa while Omicron was the dominant variant

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