Novartis expands alliance with Science 37 to advance virtual clinical trials program
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- Category: Novartis
Novartis has announced an additional strategic alliance with Science 37, a leader in decentralized clinical trial technology and design, to initiate up to 10 new clinical trials over the next three years. The studies will blend virtual and traditional models, with increasing degrees of decentralization towards a mostly "site-less" model.
Bristol-Myers Squibb's Opdivo® (nivolumab) now the first and only FDA-approved PD-1 inhibitor to offer every four-week dosing
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.
Novartis' Xolair® recommended in new global chronic urticaria guideline
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- Category: Novartis
A new global guideline on chronic urticaria (CU) recommends Xolair® (omalizumab), indicated as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines[1],[2]. Xolair is the only licensed treatment option for CSU, a type of CU, for patients unresponsive to antihistamines[1].
FDA to review Dupixent® (dupilumab) as potential treatment for moderate-to-severe asthma
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- Category: Sanofi
The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application of Dupixent® (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma. Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.
Bristol-Myers Squibb announces expansion of the International Immuno-Oncology Network (II-ON) with addition of Yale Cancer Center
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) announced that Yale Cancer Center has joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational Immuno-Oncology (I-O) science.
Novartis and Pear Therapeutics to develop digital therapeutics for patients with schizophrenia and multiple sclerosis
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- Category: Novartis
Novartis has entered into a collaboration with Pear Therapeutics to develop novel prescription digital therapeutics, software applications designed to effectively treat disease and improve clinical outcomes for patients. The collaboration brings together Novartis expertise in biomedical research and clinical development with Pear's leading experience in digital therapeutics design and implementation.
MedImmune to create stand-alone company for early-stage inflammation and autoimmunity biologics
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- Category: AstraZeneca
AstraZeneca today announced that its global biologics research and development arm, MedImmune, is spinning out six molecules from its early-stage inflammation and autoimmunity programmes into an independent biotech company, Viela Bio. The new company will focus on developing medicines for severe autoimmune diseases by targeting the underlying causes of each disease.
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