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- PMLiVE

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- 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

- PMLiVE

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

AZ’s Imfinzi boosts survival in biliary tract cancer

Positive results for Imfimzi plus chemotherapy offer hope for patients with a rare and aggressive gastrointestinal cancer

- 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...

- PMLiVE

Valneva COVID-19 vaccine more effective than AZ

Valneva will seek regulatory approval in the UK and European Union after its COVID-19 vaccine candidate performed well in phase 3 trials

- PMLiVE

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

- PMLiVE

AZ’s Imfinzi combination shows promise in liver cancer

Combining Imfinzi with experimental monoclonal antibody tremelimumab improved overall survival in patients with the most common form of liver cancer

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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

- PMLiVE

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

- PMLiVE

Results of AstraZeneca’s TACKLE phase 3 trial show antibody combination reduces risk of severe COVID-19 or death

The antibody is the only long-acting combination shown to both prevent and treat COVID-19

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