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- PMLiVE

Bendectin

- 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

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

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

- 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

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

- PMLiVE

Eli Lilly focuses on 2022 launches as revenues climb by 18%

Revenues in the third quarter of 2021 were driven by volume growth in new medicines, but earnings per share were a fraction below analysts’ predictions

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Novartis sales top £13bn in Q3 as the company reviews its generic business Sandoz

The company has started a strategic review of Sandoz as sales drop 20% in ‘challenging’ US market

- PMLiVE

Benefits of COVID-19 vaccine in younger children outweigh risks, says FDA

An FDA analysis says the benefit of Pfizer/BioNTech’s COVID-19 vaccine in children aged 5-11 years outweighs the risk, even where the incidence of SARS-CoV-2 is very low

- PMLiVE

US COVID-19 booster programme expanded

The FDA and CDC have given the green light to an expansion of the US COVID-19 booster programme to include another shot of the Moderna and J&J vaccines as well...

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