Media Room Menu
Month Year
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Month Year
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Mar 31, 2021- Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies
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Mar 15, 2021Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy
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Mar 12, 2021Fabrazyme is the only FDA-approved enzyme replacement therapy for Fabry disease with long-term efficacy and safety data
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Mar 4, 2021Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years with asthma in a randomized Phase 3 trial, while also further adding to the well-established safety profile of Dupixent
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Mar 3, 2021-One course of teplizumab delayed insulin dependence by approximately three years and improved beta cell function in at-risk (Stage 2) type 1 diabetes patients-
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Feb 25, 2021-U.S. Food and Drug Administration (FDA) filing of a Biologics License Application (BLA) and Priority Review for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals; PDUFA goal date of July 2, 2021-
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Feb 22, 2021Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials
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Feb 18, 2021- Company also Announces Presentation at the 2021 SVB Leerink Global Healthcare Conference -
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Feb 18, 2021Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential to transform therapy and provide high sustained factor activity levels for people with hemophilia A
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Feb 17, 2021- Provention Bio to receive $6 million upfront payment; up to $11.5 million in research, development and manufacturing funding; and up to $172 million in potential development, regulatory and commercial milestone payments -
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Feb 9, 2021Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC
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Feb 1, 2021-- Improvements were noted across key disease measures in certain patients with asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis
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Jan 28, 2021- PRV-3279 Murine Surrogate Inhibited the Production of Anti-adenoviral Vector Antibodies in a Mouse Model for Pompe Disease -
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Jan 4, 2021-FDA sets PDUFA goal date of July 2, 2021-
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Dec 15, 2020- Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of type 1 diabetes and celiac disease -
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Nov 18, 2020Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Bruton’s tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia
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Nov 18, 2020The FDA decision date for avalglucosidase alfa, an investigational enzyme replacement therapy, is set for May 18, 2021