Clinical Intelligence

FDA accepts for review sNDA for Pfizer’s IBRANCE metastatic breast cancer

Friday, December 23, 2016

Pfizer has announced that the FDA accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE (palbociclib). The sNDA supports the conversion of the accelerated approval of IBRANCE in combination with letrozole to regular approval and includes data from the phase III PALOMA-2 trial, which evaluated IBRANCE as initial therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. This is the same patient population as the randomized phase II PALOMA-1 trial upon which the accelerated approval of IBRANCE plus letrozole was granted in February 2015. 

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Janssen Biotech submits stelara approval application for plaque psoriasis

Monday, December 19, 2016

Janssen Biotech announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.

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CytomX to start phase I/II study of CX-072

Thursday, December 15, 2016

CytomX Therapeutics, a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, today announced that the FDA has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer. The company plans to immediately initiate the study and open clinical sites to support patient enrollment.

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FDA accepts Bayer’s sBLA for myBETAapp and BETACONNECT Navigator

Thursday, December 15, 2016

Bayer has announced that the FDA has accepted the filing of a supplemental Biologics License Application (sBLA) for myBETAapp and the BETACONNECTNavigator. MyBETAapp is intended for patients taking BETASERON (interferon beta-1b), to help them record their treatment information such as drug injections and injection sites. The BETACONNECT Navigator is a tool that enables healthcare professionals the ability to review injection history for their patients.

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Horizon Pharma announces phase III results from Friedreich’s Ataxia study

Friday, December 9, 2016

Horizon Pharma, a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, has announced that the phase III trial, STEADFAST (Safety, Tolerability and Efficacy of ACTIMMUNE Dose Escalation in Friedreich’s Ataxia study), evaluating ACTIMMUNE (interferon gamma-1b) for the treatment of Friedreich’s ataxia (FA) did not meet its primary endpoint of a statistically significant change from baseline in the modified Friedreich’s Ataxia Rating Scale (FARS‐mNeuro) at 26 weeks versus treatment with placebo. FARS‐mNeuro is an exam-based rating scale that measures disease progression based on functional parameters such as speech, ability to swallow, upper and lower limb coordination, gait and posture.

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Shire’s phase III VONVENDI study meets primary endpoint

Monday, December 5, 2016

Shire, a biotechnology company focused on serving individuals with rare diseases and other highly specialized conditions, has announced topline results from a phase III clinical trial of VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe von Willebrand disease (VWD), the most common inherited bleeding disorder.

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