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FDA grants priority review for AZ, Amgen’s tezepelumab for asthma

Drug 'has the potential to transform treatment for a broad population of severe asthma patients'

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FDA rejects Provention Bio’s type 1 diabetes prevention drug

FDA said a study of healthy volunteers failed to demonstrate that the planned commercial product is comparable to an older version used in previous clinical trials

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AstraZeneca clears latest hurdle for Alexion acquisition after EU clearance

AZ first announced the proposed acquisition of Alexion in December 2020

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Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

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Lilly showcases tirzepatide type 2 diabetes data at ADA 2021

Company is planning to submit the full data package for tirzepatide to regulatory authorities by the end of 2021

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US pauses shipments of Eli Lilly’s COVID-19 antibody treatment due to variant concerns

Laboratory analyses found the therapy was not effective against variants first discovered in South Africa and Brazil

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AZ, HUTCHMED win first approval for MET inhibitor Orpathys in China

Continued approval in MET-positive NSCLC is contingent on the completion of a positive confirmatory trial

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

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Court rules on AZ and EU’s COVID-19 vaccine dispute

The Court in Brussels has ordered AZ to deliver a total of 80.2 million doses to the EU by 27 September 2021

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Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses

Pfizer/BioNTech and AZ vaccines found to be 96% and 92% effective against variant, respectively

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AZ’s long-acting COVID-19 antibody fails to meet primary endpoint in prevention trial

AZD7442 is based on antibodies isolated from two patients who had recovered from COVID-19

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Boehringer Ingelheim, Lifebit to use AI to detect infectious disease outbreaks

Partnership will utilise real-world data for the early reporting of global outbreaks

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