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Q3 results

- 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

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

- 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

Pfizer-BioNTech booster offers 95.6% efficacy against COVID-19

Results from the world’s first randomised, controlled COVID-19 vaccine booster trial show a third dose of Pfizer-BioNTech’s Comirnaty offers near-total protection from infection

- 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

The FDA vaccine advisory board recommends booster shots of both the J&J and Moderna vaccines

J&J’s data showed that a second shot of its vaccine boosts protection to 94% against symptomatic moderate-to-severe infection when administered two months after the first dose

- PMLiVE

Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

regeneron headquarters

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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