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Biopharma companies set to release financial reports next week have reported positive news in recent months.
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Nearly two weeks after the U.S. Food and Drug Administration approved Sanofi and Regeneron’s Dupixent as an add-on maintenance therapy for moderate to severe asthma, the France-based company reported a surge in sales for the medication in its most recent quarterly report.
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Sanofi Q3 2018 Performance Confirms Return to Growth
10/31/2018
Third-quarter sales(3) growth led by Specialty Care and Vaccines with strong support from Emerging Markets
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EYLEA® (aflibercept) Injection Improves Diabetic Retinopathy and Reduces Vision-Threatening Complications in Phase 3 Trial
10/25/2018
First trial in non-proliferative diabetic retinopathy to show both a reduction in vision-threatening complications and in development of diabetic macular edema
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The FDA approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance therapy for patients with moderate-to-severe asthma. The approved group is age 12 years and older with either an eosinophilic phenotype or with an oral corticosteroid-dependent asthma.
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FDA Approves Asthma Indication for Dupixent® (dupilumab)
10/19/2018
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration has approved Dupixent® (dupilumab
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Kevzara® (sarilumab) Data at the 2018 ACR/ARHP Annual Meeting Provide Additional Insight on Safety and Efficacy in Rheumatoid Arthritis
10/19/2018
Among 13 Alliance presentations, a late-breaker poster will highlight potential for IL-6 levels to serve as a biomarker to help predict treatment response
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FDA approves asthsma indication for Dupixent® (dupilumab)
10/19/2018
The U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
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Shares of Regeneron jumped more than 5 percent Monday after the company announced that its blockbuster drug Dupixent (dupilumab) hit the mark in two Phase III trials studying the drug as a treatment for adults with inadequately-controlled chronic rhinosinusitis with nasal polyps.
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Dupixent® (dupilumab) Showed Positive Topline Results in Two Phase 3 Trials of Patients with Chronic Rhinosinusitis with Nasal Polyps
10/16/2018
Dupixent significantly reduced nasal polyp size, nasal congestion severity and need for systemic corticosteroids and/or surgery
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Aimmune Therapeutics Announces Initiation of Phase 2 Study With Regeneron and Sanofi of AR101 With Adjunctive Dupilumab in Peanut-Allergic Patients
10/15/2018
Trial Will Build on the Positive, Pivotal Phase 3 PALISADE Trial of AR101.
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The AP in a recent report notes that drug price increases “slowed somewhat and were not quite as steep as in past years.” But overall, there has been no “massive” drug price cuts.
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Libtayo® (cemiplimab-rwlc) Data at ESMO 2018 Congress Provide New Insights in Six Tumor Types Under Investigation
10/8/2018
ESMO data demonstrate breadth of joint Regeneron and Sanofi immuno-oncology development program
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An estimated 15 million people in the United States have allergies to more than 170 different foods, according to the non-profit Food Allergy Research and Education. New health data suggests the frequency of food allergies in children under 18 has risen 70 percent since 1997, CNBC reported.
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FDA Approves Libtayo® (cemiplimab-rwlc) as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma
9/28/2018
Libtayo is the third anti-PD-1 approved in the U.S.
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FDA approves Libtayo (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma
9/28/2018
Libtayo is the third anti-PD-1 approved in the U.S.
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Positive Phase 3 Results Presented for Dupixent® (dupilumab) Show Significant Improvement on Multiple Measures of Disease Severity in Adolescents with Moderate-to-Severe Atopic Dermatitis
9/15/2018
Results on skin clearing, itch and certain quality of life measurements were presented today as a late-breaking oral presentation at the 27th EADV Congress
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FDA to Review EYLEA (aflibercept) Injection for the Treatment of Diabetic Retinopathy
9/13/2018
The target action date for the FDA decision is May 13, 2019.
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FDA to review supplemental Biologics License Application for Praluent® (alirocumab) Injection as potential treatment to reduce major adverse cardiovascular events
9/12/2018
* FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy
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FDA to Review Supplemental Biologics License Application for Praluent® (alirocumab)Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events
9/12/2018
Last month, FDA also approved Praluent label update for some patients currently requiring LDL apheresis therapy