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AZ’s Saphnelo receives EU approval for systemic lupus erythematosus

There are an estimated 250,000 people living with SLE in Europe and this is the first new drug to gain EU approval in over ten years

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Eli Lilly’s Omicron drug treatment gets emergency use authorisation from FDA

The drug can be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings

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WHO issues prequalification for Roche’s Actemra/RoActemra for severe or critical COVID-19

The prequalification confirms the treatment meets WHO’s standards for quality, effectiveness and safety

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Merck and Ridgeback fulfil US deal for molnupiravir

Over three million courses of the investigational oral antiviral COVID-19 treatment have been supplied

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

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Celltrion submits application for inhaled COVID-19 antibody treatment

A global phase 3 clinical study will evaluate the inhaled antibody cocktail treatment for patients with mild-to-moderate COVID-19 symptoms

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Six million patients affected by delay to NHS England’s plans to address COVID-19 backlog

UK’s health and social care secretary Sajid Javid said that the number of patients on these hospital waiting lists would increase before beginning to fall

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MHRA issues CMA for Novavax COVID-19 vaccine

Nuvaxovid offers up to 89% protection against COVID-19

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NICE recommends AZ’s Forxiga for kidney disease

The recommendation is based on results from a phase 3 trial

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New Omicron subvariant appears more transmissible but no more severe than original Omicron strain

The new subvariant is already emerging as a dominant strain in Denmark, the Philippines, Nepal, Qatar and India

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Pfizer’s Paxlovid receives positive opinion from CHMP

If authorised, the drug would be the first COVID-19 oral treatment recommended in the EU

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Moderna begins phase 2 trial of Omicron-specific booster

The study will include two groups, with approximately 300 people in each group

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