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regulatory decisions

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Novartis’ Cosentyx recommended by CHMP for hidradenitis suppurativa

An estimated one in 100 people globally are affected by the inflammatory skin disease

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EMA addresses considerations for single-arm trials as pivotal evidence in regulatory filings

The reflection paper offers suggestions on trial design and strategies for minimising bias

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Bristol Myers Squibb’s plaque psoriasis treatment recommended by CHMP

At least 100 million people worldwide are impacted by some form of psoriasis

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Sanofi/Regeneron’s Dupixent recommended by CHMP for atopic dermatitis in children

If approved, the medicine would be the first and only targeted option in the EU for this age group

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Sandoz’s high concentration Hyrimoz formulation recommended for use in EU

The recommendation includes multiple indications such as rheumatoid arthritis and Crohn’s disease

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EU outlines measures to mitigate antibiotic shortage across Europe

An unseasonably early upsurge in respiratory infections has led to the increase in demand

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EU to revise pharmaceuticals law amid antibiotic shortages

The early upsurge in respiratory infections has led to a sudden increase in demand for antibiotics

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AstraZeneca’s severe asthma treatment approved in EU for self-administration

Most healthcare providers, patients and caregivers are able to successfully use the pre-filled pen

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Jasper Therapeutics’ briquilimab given orphan drug designation in EU

The drug will be used for transplant patients with SCID, AML and MDS

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CHMP recommends use of Moderna’s Omicron BA.1 booster in children in the EU

The company is also evaluating the use of the vaccine in children aged from six months

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Sanofi/ Regeneron’s Dupixent recommended by CHMP to treat eosinophilic oesophagitis

Patients in a phase 3 trial experienced improvements in their ability to swallow after four weeks

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EMA’s emergency task force backs bivalent COVID-19 vaccines for primary vaccination

National authorities may decide to use the vaccines in their primary vaccination campaigns

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