Clinical Intelligence

FDA grants Priority Review for Genentech’s Actemra

Wednesday, February 1, 2017

Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted Priority Review designation for Actemra for the treatment of giant cell arteritis (GCA). The designation is based on the positive outcome of the phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.

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ImmunoGen doses first patient in phase III ovarian cancer study

Friday, January 27, 2017

ImmunoGen, a provider of antibody-drug conjugates (ADCs) for the treatment of cancer, has announced that the first patient has been dosed in FORWARD I, the company’s phase III clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a first-in-class, folate receptor alpha (FRα)-targeting ADC.

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Pfizer posts positive phase II C. difficile vaccine results

Friday, January 27, 2017

Pfizer announced that the phase II study evaluating the company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis, by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced by C. difficile (toxins A and B).

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Synergy’s Trulance FDA approved for chronic idiopathic constipation

Monday, January 23, 2017

The FDA has approved Synergy Pharmaceuticals’ Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

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