Clinical Intelligence

The CenterWatch Monthly, October 2012

Monday, October 1, 2012 01:22 PM

CRCs workload up: relative pay declining

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Novartis receives E.C. approval for once-daily Seebri Breezhaler for COPD

Monday, October 1, 2012 12:11 PM

The European Commission has approved Novartis’ Seebri Breezhaler (glycopyrronium bromide) 44µg delivered dose, as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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FDA approves first subcutaneous heart defibrillator

Monday, October 1, 2012 11:51 AM

The FDA has approved Cameron Health’s subcutaneous implantable defibrillator (S-ICD) system, a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted subcutaneously instead of connected directly into the heart.

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FDA approves new treatment for advanced colorectal cancer

Friday, September 28, 2012 12:19 PM

The FDA has approved Bayer’s and Onyx Pharmaceuticals’ Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body.

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PsiOxus launches phase I/II trial of oncolytic vaccine in metastatic cancer

Wednesday, September 26, 2012 12:07 PM

PsiOxus Therapeutics, a U.K.-based development stage biotech, has treated the first patient in its phase I/II clinical trial of ColoAd1for the treatment of metastatic solid tumors.

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Clarus touts top-line results in phase III testosterone replacement study

Tuesday, September 25, 2012 02:39 PM

Clarus Therapeutics, a Northbrook, Ill.-based privately held biopharmaceutical company focused on oral T replacement products, released top-line results from its ongoing phase III study of CLR-610, a proprietary oral testosterone (T) replacement product.

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Lundbeck files for EMA approval of vortioxetine for depression

Friday, September 21, 2012 01:34 PM

H. Lundbeck, an international pharmaceutical company, has submitted a marketing authorization application (MAA) to the EMA for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review.

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Mayo Clinic researchers identify new enzyme to fight Alzheimer's

Wednesday, September 19, 2012 12:58 PM

An enzyme that could represent a powerful new tool for combating Alzheimer's disease has been discovered by researchers at Mayo Clinic in Florida.

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Navidea Biopharma enrolls first patient in phase II Alzheimer’s trial of NAV4694

Wednesday, September 19, 2012 12:31 PM

Navidea Biopharmaceuticals, a Dublin, Ohio-based biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has commenced enrollment at two sites participating in its phase II, open-label, safety and efficacy PET imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with probable Alzheimer's disease (AD).

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FDA approves new multiple sclerosis treatment Aubagio

Friday, September 14, 2012 12:48 PM

The FDA has approved Sanofi Aventis’ Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

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