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.
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.
Cambridge, Mass.-based Ironwood Pharmaceuticals has announced that the phase III clinical trial of its 72mcg dose of linaclotide in adults with chronic idiopathic constipation (CIC) met the primary endpoint. Ironwood and partner Allergan intend to submit a supplemental new drug application to the FDA in the first half of 2016.
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.
The Simplexa Flu A/B & RSV Direct Kit from Cypress, Calif.-based Focus Diagnostics—the products business of Madison, N.J.-based Quest Diagnostics—has received 510(k) clearance from the FDA for 46 additional influenza A and influenza B virus strains and seven additional respiratory syncytial virus (RSV) strains.
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.
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.
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.