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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

- PMLiVE

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

- PMLiVE

Roche to present new data for its drug Polivy at the American Society of Hematology’s annual meeting

The company will present 90 abstracts from across a wide range of haematologic diseases, including results from three pivotal studies in lymphoma and haemophilia

regeneron headquarters

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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UK’s NICE recommends Roche’s Evrysdi

The first oral therapy for the leading genetic cause of death among babies and young children will be available to 1,500 people in England after Roche signed a price-cutting deal

- PMLiVE

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

- PMLiVE

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

regeneron headquarters

Regeneron’s COVID-19 antibody cocktail approved in Europe

Ronapreve (REGEN-COV in the US) has been approved for non-hospitalised, at-risk patients and for prevention of COVID-19

Biogen Idec building

Biogen investigating death linked to Aduhelm

The death of a 75-year-old patient taking Biogen’s Aduhelm has raised yet more questions around the recently approved Alzheimer’s therapy

regeneron headquarters

Regeneron’s antibody cocktail REGEN-COV offers sustained protection against COVID-19

The drug is shown to give sustained protection against COVID-19, cutting the risk of infection by more than 80% for up to eight months

- PMLiVE

Pfizer’s oral antiviral Paxlovid significantly cuts risk of severe COVID-19

Pfizer has halted its phase 2/3 trial of its new antiviral combo Paxlovid after analysis shows it cuts the risk of hospitalisation or death from COVID-19 by nearly 90%

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