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AZ, Amgen file first-in-class asthma drug with the FDA

Submission is based on positive results from the companies’ PATHFINDER clinical programme

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EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19

Rolling review supported by interim analysis of data from phase 3 COMET-ICE trial

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GSK’s revenue drops by 18% in Q1 as performance pressures mount

Chief executive Emma Walmsley said results ‘reflect the anticipated impacts of COVID-19’

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GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer

AnaptysBio earns a $20m milestone payment on approval after originally developing the drug

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EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

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GSK discontinues two feladilimab trials in head and neck cancer

Decision made after recommendation from Independent Data Monitoring Committee

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J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

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FDA approves new self-injection administration for Xolair

Drug is approved for asthma and other allergic and inflammatory conditions

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New restrictions for AZ/Oxford COVID-19 vaccine despite EMA endorsement

Regulators in Canada and Germany have reportedly placed new restrictions on vaccine

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GSK to assist in manufacturing up to 60 million doses of Novavax’s COVID-19 vaccine in the UK

Vaccine candidate is expected to be submitted to UK regulatory authorities in Q2

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Lilly, Vir and GSK’s antibodies reduce viral load by 70% in low-risk COVID-19 patients

The two neutralising antibodies bind to different epitopes of the SARS-CoV-2 spike protein

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EMA recommends new manufacturing sites for COVID-19 vaccines

EMA also recommends new storage temperature for Pfizer/BioNTech vaccine

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