FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
Sanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another label expansion, this time for the rare autoimmune…
Immunology
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Genentech eyes lupus market for Gazyva with positive Phase III data readout
Roche’s subsidiary Genentech has shared positive Phase III data with the US Food and Drug Administration (FDA) as the company…
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FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases
The US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer…
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COPD market to expand with AstraZeneca’s focus on biologics and strong portfolio growth
The chronic obstructive pulmonary disease (COPD) market continues its trajectory of rapid growth, bolstered by significant advancements in biologics and…
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Insmed’s gene therapy poised to challenge DMD landscape after IND clearance
Duchenne muscular dystrophy (DMD) is a rare genetic disorder that is characterised by progressive muscle degeneration and weakness, and is…
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Palforzia’s peanut allergy treatment use in Europe expanded to toddlers
The European Commission (EC) has approved the extension of Stallergenes Greer’s Palforzia (defatted powder of Arachis hypogaea L., semen (peanut))…
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Candid Therapeutics signs $925m T-cell engager deal with WuXi Biologics
US-based Candid Therapeutics has signed another T-cell engager (TCE) partnership, this time with Chinese biotech WuXi Biologics for the global…
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Palleon and Shanghai Henlius Biotech link on autoimmune therapy
Palleon Pharmaceuticals and Shanghai Henlius Biotech have entered a licence agreement and partnership for the former’s sialidase enzyme therapeutic, E-602,…
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AbbVie to acquire Nimble Therapeutics for $200m
AbbVie has agreed to acquire Nimble Therapeutics for $200m in cash at closing, subject to standard adjustments, alongside potential interim…
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CHMP recommends oral peanut allergy immunotherapy treatment for toddlers
The European Medicines Agency’s (EMAs) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of Stallergenes…
