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Tezspire approved in US for severe asthma

AstraZeneca and Amgen’s monoclonal antibody Tezspire is now available to control dangerous exacerbations in all adults and children aged 12 years and above with severe asthma

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FDA approves first drug to prevent graft-versus-host disease

Bristol Myers Squibb’s arthritis drug, Orencia, can now be given to adults and children undergoing stem cell transplants to prevent the life-threatening condition

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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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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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Mix-and-match COVID-19 vaccines may be more effective

A small study shows a booster shot of J&J’s vaccine six months after a primary course of the Pfizer/BioNTech vaccine may offer more protection

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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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Annual COVID-19 jabs likely, says Pfizer head

Pfizer CEO predicts annual jabs will be needed to maintain a ‘very high level of protection’ against COVID-19 and emphasises the need to vaccinate children

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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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Regeneron signs $900m cancer and infectious disease deal with Nykode

The deal with Norwegian clinical-stage vaccine specialist Nykode (previously Vaccibody) includes an upfront payment of $30m and an equity investment of $20m plus additional payments

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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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