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- PMLiVE

aflibercept

- PMLiVE

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

- PMLiVE

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%

- PMLiVE

bluebird bio splits to create new oncology firm 2seventy bio

2seventy bio gets the company’s immune-oncology cell therapies products, while bluebird bio will continue its work on severe genetic diseases

- PMLiVE

Roche and Novartis part ways with share purchase

Novartis is to sell its one-third stake in Roche for more than $20bn, paving the way for potential acquisitions

- PMLiVE

Bespoke Gene Therapy Consortium created to collaborate in development of rare disease gene therapies

Ten pharma companies will team up with the FDA, NIH and five non-profits to accelerate the development of gene therapies to treat rare inherited diseases

- PMLiVE

FDA experts recommend COVID-19 vaccine for 5-11 year-olds

The advisory committee voted overwhelmingly to recommend Pfizer-BioNTech’s Comirnaty for children aged 5-11, although some experts expressed concerns

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