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- PMLiVE

Gamifant

- PMLiVE

GSK’s RSV vaccine candidate recommended by CHMP for older adults

RSV infections in older adults account for over 270,000 hospitalisations each year in Europe

- PMLiVE

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

- PMLiVE

Sanofi and Sobi’s once-weekly haemophilia A treatment approved by FDA

Current factor VIII therapies usually require patients to receive treatment every two days

- PMLiVE

Bristol Myers Squibb’s plaque psoriasis treatment recommended by CHMP

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

- PMLiVE

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

- PMLiVE

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

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

- PMLiVE

EU outlines measures to mitigate antibiotic shortage across Europe

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

- PMLiVE

EU to revise pharmaceuticals law amid antibiotic shortages

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

- PMLiVE

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

- PMLiVE

Jasper Therapeutics’ briquilimab given orphan drug designation in EU

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

- PMLiVE

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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