Clinical Intelligence

FDA approves OTC Oxytrol for Women for overactive bladder

Monday, January 28, 2013 10:53 AM

The FDA has approved Merck’s Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older. Oxytrol will remain available for men with overactive bladder by prescription only.

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EntreMed initiates phase II trial in advanced/metastatic soft tissue sarcoma

Friday, January 25, 2013 01:11 PM

EntreMed, a clinical-stage pharmaceutical company, has initiated a single-center phase II study of oral ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma at Princess Margaret Hospital where the study is led by Malcolm Moore, MD and Albiruni R.A. Razak, MD.

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Gilead initiates phase III program for tenofovir alafenamide for HIV

Friday, January 25, 2013 11:30 AM

Gilead Sciences, a biopharmaceutical company based in Foster City, Calif., has initiated the first of two phase III clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.

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ReCor receives CE mark for ultrasound-based renal denervation system

Thursday, January 24, 2013 02:00 PM

ReCor Medical, a private venture-backed, early-stage company focused on ultrasound catheter technology, has received CE mark for its next-generation Paradise system, a minimally invasive 6Fr over-the-wire (OTW) ultrasound device for treating resistant high blood pressure.

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Tresiba and Ryzodeg receive marketing authorizations in Europe

Wednesday, January 23, 2013 11:54 AM

The European Commission has granted marketing authorizations for Novo Nordisk’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults.

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Cancer Research U.K. and Astex’s CRT initiate AT13148 trial for cancer

Friday, January 18, 2013 03:18 PM

Cancer Research Technology (CRT), the commercial arm of Astex Pharmaceuticals, a pharmaceutical company focused on novel small molecule therapeutics, along with its collaborator Cancer Research U.K., has initiated a trial of an experimental drug shown to simultaneously block many enzymes that control cancer cell growth and death.

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GSK submits albiglutide BLA to FDA for T2D

Monday, January 14, 2013 02:20 PM

GlaxoSmithKline (GSK), a global research-based pharmaceutical and healthcare company, announced a regulatory submission to the FDA for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. 

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Telik receives Orphan status for Telintra for myelodysplastic syndrome

Monday, January 14, 2013 09:42 AM

Telik, a clinical stage drug development company focused on developing small molecule drugs to treat cancer, was notified today that its product candidate, ezatiostat HCL (Telintra), has been granted Orphan Drug designation by the FDA for the treatment of myelodysplastic syndrome (MDS). 

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KaloBios initiates phase II study with KB001-A in cystic fibrosis

Friday, January 11, 2013 12:10 PM

KaloBios Pharmaceuticals, a biopharmaceutical company based in San Francisco, Calif., has initiated dosing in a randomized, double-blind, placebo-controlled phase II clinical trial of KB001-A, the company's anti-PcrV Humaneered, PEGylated monoclonal antibody fragment. The study will investigate the safety and efficacy of intravenously administered KB001-A as a treatment for chronic Pseudomonas aeruginosa (Pa) infection in cystic fibrosis patients.

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CoDa boasts positive results in phase IIb study of Nexagon in chronic venous leg ulcers

Thursday, January 10, 2013 08:00 AM

CoDa Therapeutics, a clinical stage biotechnology company, released positive results from a phase IIb clinical trial of Nexagon in patients with chronic venous leg ulcers, which supports advancing Nexagon into phase III registration trials.

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