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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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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

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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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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

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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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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

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Engaging HCPs on their own terms: how pharma can adapt to the post-pandemic digital era

By Michael Brandreth, Group Vice President of Medscape

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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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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Merck and Ridgeback request EUA from US FDA for COVID-19 drug molnupiravir

If authorised, molnupiravir could be the first oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in at risk adults

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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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