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LentiGlobin

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Almirall receives CHMP recommendation for lebrikizumab in atopic dermatitis

The drug has been recommended as a treatment option for adult and adolescent patients

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Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine recommended by CHMP

Doses will be ready to ship immediately upon authorisation by the European Commission

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EMA endorses digital measure as primary endpoint in Duchenne muscular dystrophy trials

The decision qualifies SV95C as an alternative to the widely used six-minute walking test

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EMA reports actions to improve EU clinical trials conducted during health emergencies

All proposed actions will be acknowledged by the European Commission, EMA and member states

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Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns

Evrysdi is already approved in the EU to treat SMA patients aged two months or older

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Bristol Myers Squibb’s Opdivo recommended by CHMP for expanded melanoma use

The global incidence of skin cancer has been rising steadily over the past few decades

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Merck granted positive CHMP opinion for Keytruda combination in gastric cancer

Over one million new cases of gastric cancer were diagnosed globally in 2020

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Janssen receives positive CHMP opinion for Talvey in multiple myeloma

More than 50,900 people in Europe were diagnosed with multiple myeloma in 2020

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Sandoz granted positive CHMP opinion for multiple sclerosis biosimilar

The neurological disease affects approximately 2.8 million people worldwide

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bluebird bio’s sickle cell gene therapy accepted for FDA priority review

The genetic disease affects approximately 100,000 people in the US

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EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The EU regulator concluded that the benefits of Adakveo did not outweigh its risks

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bluebird bio submits US application for sickle cell gene therapy

The genetic disease affects approximately 100,000 people in the US alone

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