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Biogen’s Alzheimer’s drug Aduhelm

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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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Biogen agrees $850m felzartamab rights deal with TJ Biopharma

The agreement gives Biogen full global rights to the investigational antibody across immune-mediated diseases

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MHRA authorises Biogen’s higher-dose Spinraza for SMA treatment

SMA is a rare genetic neuromuscular condition affecting around 1,600 people in the UK

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Biogen to acquire Apellis in $5.6bn deal

The deal will enhance Biogen’s growth portfolio in immunology and rare disease

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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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Eisai and Biogen’s new data shows Alzheimer’s patients choose to stay on Leqembi long-term

The findings were presented at the 20th International Conference on Alzheimer’s and Parkinson’s Diseases in Denmark

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The draft guidance specifically discusses genome editing and RNA-based therapies

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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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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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Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for lupus

Therapies like topical steroids manage symptoms but there is currently no cure

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Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

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