Clinical Intelligence

FDA OKs first reversal agent for Pradaxa

Monday, October 19, 2015

The FDA has granted Accelerated Approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

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J&J begins Ebola vaccine regimen in Sierra Leone

Monday, October 19, 2015

Johnson & Johnson (J&J) has begun a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. It is the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.

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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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