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FDA gives Rare Paediatric Disease designation to Satellite Bio for urea cycle disorders

The mortality rates of UCDs exceeds 25%, with no curative treatment available for newborns

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Allergan Aesthetics launches Skin Quality Index for aesthetic consultations

Spanning four dimensions of skin health, the framework introduces 15 terms and definitions

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BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma

This type of cancer is the most common one diagnosed in teenagers

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US FDA launches ultra-rare diseases framework

The draft guidance specifically discusses genome editing and RNA-based therapies

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Novo Nordisk and Vivtex partner in deal worth up to $2.1bn

The companies aim to develop next-generation oral medicines for obesity and diabetes

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PureTech’s deupirfenidone gets FDA and EC Orphan Drug Designations for idiopathic pulmonary fibrosis

Rare diseases are defined as conditions affecting fewer than 200,000 people in the US or fewer than five in 10,000 individuals in the European Union

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Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input

While a lack of meal announcements can lead to lower glycaemic control, it reduces the mental burden for those with type 1 diabetes

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Bayer launches ‘Anything but Normal’ campaign highlighting women’s health issues

Over 1.5 billion women worldwide – almost one in two women – experience women’s health issues

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Johnson & Johnson’s Darzalex Faspro regimen receives FDA approval for multiple myeloma

Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable

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AstraZeneca and CSPC Pharmaceuticals enter collaboration on weight management therapies

Almost three billion people globally are thought to be either overweight or obese

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Novartis’ ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Approximately half of those with Sjögren’s disease are thought to be undiagnosed

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Novo Nordisk’s Wegovy higher dose injection approved by UK MHRA for obesity

Obesity affects approximately 15 million people in the UK

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