Clinical Intelligence

GTx to initiate SUI trial

Wednesday, October 14, 2015

GTx, a Memphis-based biopharmaceutical company, has announced that the FDA has accepted the company’s investigational new drug (IND) application for a phase II clinical trial to treat postmenopausal women with stress urinary incontinence (SUI). The IND enables GTx to initiate a phase II proof-of-concept trial of enobosarm that will be the first clinical trial to evaluate a selective androgen receptor modulator (SARM) for SUI. The company plans to initiate the trial by the first quarter of 2016 and anticipates top-line data later in 2016.

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Portola’s betrixaban gets FDA Fast Track

Wednesday, October 14, 2015

The FDA has granted Fast Track designation to South San Francisco-based Portola Pharmaceuticals’ betrixaban for extended-duration prevention of venous thromboembolism (VTE), or blood clots, in acute medically ill patients (i.e., those who are hospitalized for serious medical conditions such as heart failure, stroke, infection and pulmonary disease). Betrixaban is an investigational oral anticoagulant that directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis.

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FDA backs Tarix Orphan’s potential DMD treatment

Tuesday, October 6, 2015

Cambridge, Mass.-based Tarix Orphan, a privately held biopharmaceutical company focused on the treatment of rare neuromuscular disorders and connective tissue diseases, has received the FDA’s Fast Track Designation for TXA127 (angiotensin 1-7) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

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FDA approves cancer drug Keytruda

Monday, October 5, 2015

The FDA has granted Accelerated Approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

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FDA accepts Sandoz submission for proposed biosimilar

Monday, October 5, 2015

The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.

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Neothetics initiates body contouring study

Thursday, October 1, 2015

Neothetics, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, has initiated the safety study, LIPO-202-CL-21, of LIPO-202, the first noninvasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the FDA as part of the company’s NDA package for LIPO-202, which the company anticipates filing in the second half of 2016.

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NIH launches substance use and adolescent brain development study

Monday, September 28, 2015

The NIH has awarded 13 grants to research institutions around the country as part of a study about the effects of adolescent substance use on the developing brain. The Adolescent Brain Cognitive Development (ABCD) Study will follow about 10,000 children beginning at ages 9 and 10, before they initiate drug use, through the period of highest risk for substance use and other mental health disorders. Scientists will track exposure to substances (including nicotine, alcohol and marijuana), academic achievement, cognitive skills, mental health and brain structure and function using advanced research methods.

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