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FDA approves first pre-exposure prophylactic against COVID-19

AstraZeneca’s (AZ) Evushield offers long-acting protection against COVID-19 in people who are either unable to receive or mount an insufficient response to a vaccine

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‘Excitement’ around new data for Enhertu

New analyses from the DESTINY-Breast03 trial shows Enhertu is effective against metastatic HER2-positive breast cancer in specific patient subgroups including those with stable brain metastases

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AstraZeneca and Ionis sign $3.6bn deal for eplontersen

The liver-targeted antisense therapy is in phase 3 trials for the treatment of transthyretin amyloidosis, a systemic, progressive and fatal condition

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Keytruda gains eighth FDA approval this year

Merck’s megablockbuster Keytruda has returned to its roots with a new indication in melanoma, the therapy area where it was first approved seven years ago

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AstraZeneca blocks take-private buyout of Sobi

The $7.6bn takeover of Swedish rare disease company Sobi by private equity group Advent International and Singapore’s wealth fund failed to convince the 90% of shareholders needed

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US regulators set to approve oral antiviral against COVID-19

The FDA looks set to authorise Merck’s molnupiravir after its advisory body recommended the antiviral treatment, while Pfizer’s Paxlovid may be next

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COVID-19 vaccines against Omicron may be fast-tracked

Regulators including the Food and Drug Administration (FDA) may treat Omicron-specific mRNA vaccines like seasonal flu vaccines, speeding up approval

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AstraZeneca officially opens new R&D facility in UK

The high-tech £1bn research and development DISC facility in Cambridge, UK will see 2,000+ scientists housed in a building designed to the highest environmental standards

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bluebird bio’s beti-cel accepted for priority review by FDA

The tough journey to approval for beta-thalassemia gene therapy (beti-cel) in the US may be coming to an end, with approval possible by 2022

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US government to pay $5.3bn for Pfizer‘s Paxlovid

If approved by the FDA, the US government will purchase 10 million courses of Pfizer’s anti-COVID protease inhibitor antiviral therapy, Paxlovid, this year and into 2022

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AstraZeneca/Moderna’s mRNA treatment for heart failure looks promising

The therapy – an mRNA-encoding vascular endothelial growth factor – looks promising for patients undergoing coronary artery bypass surgery

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US President Biden nominates Robert Califf as FDA commissioner

Biden said Califf has both the experience and expertise to lead the FDA “during a critical time in our nation’s fight” against the coronavirus pandemic

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