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Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).
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Regeneron
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Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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Novo Nordisk manufacturing facility, and clients, hit by FDA action
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
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First-of-a-kind EU approval granted for eosinophilic esophagitis medicine
With its novel approach for addressing a fundamental cause of eosinophilic esophagitis, approval of the biologic marks a potential new standard of care for paediatric patients.
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First medicine approved in EU for eosinophilic esophagitis
Dupixent® has been approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis.
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European Commission approves first medicine for prurigo nodularis
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
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Dupixent® delivers histological remission for paediatric EoE patients
Phase III trial data shows Dupixent® (dupilumab) has the potential to improve signs of eosinophilic oesophagitis (EoE) and support healthy weight gain in children with the condition.
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MCAP for top bio/pharma companies reached $3.4 trillion in 2021
Market capitalisation (MCAP) for the top bio/pharma companies grew 24.9 percent in 2021, with BioNTech and Moderna entering the top 20 for the first time.
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US government purchases additional 1.4 million doses of REGEN-COV™
Regeneron announced a new US government agreement to purchase additional doses of REGEN-COV (casirivimab and imdevimab) antibody cocktail.
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‘Magic bullets’ for all: democratising biologics by rethinking antibody development, manufacturing and delivery
Antibody therapeutics revolutionised how diseases like cancer are treated in the developed world, but their high manufacturing cost and cumbersome distribution and administration leave them out of reach for most. In this guest article, Lumen Bioscience’s CEO, Brian Finrow, and EVP of Production & Development, Craig Behnke, discuss how new…
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Libtayo® with chemotherapy trial stopped early due to success
Phase III trial of Libtayo® (cemiplimab) combined with chemotherapy stops early due to significant improvement in overall survival in lung cancer patients.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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Antibody cocktail improves survival in seronegative hospitalised COVID-19 patients
Phase III data shows REGEN-COV™ (casirivimab and imdevimab) reduced risk of death by 20 percent in hospitalised COVID-19 patients lacking an immune response to SARS-CoV-2.
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Libtayo® improves overall survival in advanced cervical cancer patients
A Phase III trial evaluating Libtayo® (cemiplimab) monotherapy in advanced cervical cancer has been stopped early due to a positive result on overall survival.
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FDA approves Libtayo® monotherapy for non-small cell lung cancer patients
The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
