J&J’s nipocalimab gets FDA Fast Track designation for lupus
The autoimmune disease affects approximately three to five million people globally
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Regulatory
Incyte Biosciences UK announces NICE approval for Opzelura for vitiligo
This is the first approved treatment option in the UK for patients with non-segmental vitiligo
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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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UCB’s Kygevvi receives positive CHMP opinion for thymidine kinase 2 deficiency
TK2d is an extremely rare disease characterised by severe and progressive muscle weakness
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AstraZeneca and Daiichi Sankyo’s Datroway given FDA Priority Review for breast cancer treatment
Approximately 70% of metastatic triple-negative breast cancer patients are ineligible for immunotherapy, creating an unmet medical need
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AstraZeneca’s Imfinzi regimen receives positive CHMP opinion for early gastric and gastroesophageal cancer
Gastric cancer is the fifth highest cause of cancer deaths worldwide, with almost a million people diagnosed annually
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Sanofi’s Rezurock receives positive CHMP opinion for chronic graft-versus-host disease
Up to 50% of allogeneic haematopoietic stem cell transplant patients develop chronic GVHD
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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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Sanofi and Regeneron’s Dupixent receives positive NICE final draft guidance for COPD
Around 1.4 million people in the UK are diagnosed with COPD, with two million thought to be undiagnosed
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GSK’s Arexvy RSV vaccine receives expanded EC approval for use in adults
RSV affects approximately 64 million people around the world each year
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