Split Decision as COPD Drug Itepekimab Fails One Clinical Trial
Sanofi and Regeneron's COPD drug candidate itepekimab met its primary endpoint in one phase 3 study but failed in a second trial.
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Split Decision as COPD Drug Itepekimab Fails One Clinical Trial
Sanofi and Regeneron’s COPD drug candidate itepekimab met its primary endpoint in one phase 3 study but failed in a second trial.
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FDA Approves Dupixent for COPD
The FDA has approved Dupixent for adults with inadequately controlled COPD and an eosinophilic phenotype.
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Dupixent Wins Approval in Europe for COPD
The European Commission has approved Dupixent as an add-on treatment for adults with uncontrolled COPD.
Read MoreDupixent Significantly Reduced COPD Exacerbations in Second Phase 3 Trial
The second Dupixent investigational phase 3 COPD trial has shown that Dupixent reduced exacerbations by 34%, confirming positive published results from the phase 3 BOREAS trial.
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FDA: Two Monoclonal Antibody Treatments Ineffective Against Omicron Variant
The FDA has removed two monoclonal antibody therapies from its list of emergency authorized COVID-19 treatments due to their ineffectiveness against the Omicron variant.
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Regen-Cov Reduced COVID Risk for up to Eight Months
A single dose of Regeneron Pharma’s antibody cocktail casirivimab and imdevimab (trade name Regen-Cov) reduced the risk of COVID-19 by 81.6% for up to eight months, according to a Phase 3 trial.
Read MoreDupilumab Gets Expanded Approval for Moderate-to-severe Asthma in Children Age 6-11
The FDA has approved dupilumab (Dupixent, Regeneron) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
Read MoreDupilumab May Improve Lung Function in Children Age 6-11 with Uncontrolled, Moderate to Severe Asthma
Children age 6-11 with uncontrolled, moderate-to-severe asthma and a type 2 inflammatory asthma phenotype who received add-on dupilumab (Dupixent, Regeneron) had significant improvements in lung function at week 12 of therapy, according to research presented at Chest 2021.
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WHO Recommends Regen-COV for COVID-19 Patients at High Risk of Hospital Admission
A WHO panel of international experts and patients has recommended Regeneron’s Regen-COV (casirivimab and imdevimab) for two groups of COVID-19 patients.
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FDA Expands Authorized Use of Regen-Cov as Preventative Treatment
The FDA expanded authorization of Regen-Cov to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination.
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Libtayo plus Chemo Significantly Improved Overall Survival in Advanced NSC Lung Cancer
Adding Libtayo to chemotherapy significantly improved median overall survival in advanced non-small cell lung cancer patients from 13 to 22 months, leading to a 29% reduction in the risk of death, compared to chemotherapy alone.
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Regen-Cov Reduced COVID-19 Hospital Mortality by 20% in Seronegative Patients
Regen-Cov (casirivimab and imdevimab) added to usual care reduced the risk of death by 20% in hospitalized patients who had not mounted a natural antibody response on their own against SARS-CoV-2.
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FDA Okays Lower Dose of Regeneron Monoclonal Antibody Cocktail
Regeneron’s COVID-19 monoclonal antibody cocktail (casirivimab + imdevimab) is now authorized at half the dose for patients age 12 and older.
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Regeneron Monoclonal Antibodies Reduced COVID-19 Transmission Risk by 81%
Regen-CoV — a monoclonal antibody cocktail from Regeneron — reduced the risk of symptomatic SARS-CoV-2 infections by 81% in a Phase 3 clinical trial.
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FDA Authorizes Regeneron’s Monoclonal Antibody Treatment for COVID-19
The FDA issued an emergency use authorization for Regeneron’s casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in patients 12 and older.
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