Clinical Intelligence

The CenterWatch Monthly, February 2013

Friday, February 1, 2013 10:48 AM

Sized out of big deals, mid-tier CROs still thriving

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FDA grants Soligenix Fast Track for OrbeShield for gastrointestinal acute radiation syndrome

Thursday, January 31, 2013 02:00 PM

Soligenix, a development-stage biopharmaceutical company, announced today that its OrbeShield (oral beclomethasone 17, 21-dipropionate or oral BDP) development program for the treatment of gastrointestinal acute radiation syndrome (GI ARS) has received Fast Track designation from the FDA.

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FDA approves Gleevec for children with acute lymphoblastic leukemia

Monday, January 28, 2013 11:22 AM

The FDA has approved a new use for Novartis’ Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

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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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