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Vytorin

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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

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Merck’s $11.5bn acquisition of Acceleron delayed

Merck’s acquisition of Acceleron will take longer than expected as it refiles its paperwork, giving the FTC more time for review and itself more time to sell the deal to...

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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

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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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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

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Merck’s COVID-19 antiviral under review in Europe by EMA

Molnupiravir could be the first oral antiviral treatment for COVID-19 in Europe for patients at risk of severe disease

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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

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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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Biosimilars boosted by FDA’s landmark ruling for Boehringer’s Cyltezo

The FDA has approved Boehringer’s Cyltezo (adalimumab-adbm) as ‘interchangeable’ with Humira (adalimumab) in a landmark ruling

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FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

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FDA approves Eli Lilly’s Verzenio in high risk early breast cancer

Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- early breast cancer

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