Clinical Intelligence

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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Omeros files IND application for lead compound in schizophrenia program

Monday, September 10, 2012 11:54 AM

Omeros, a Seattle-based clinical-stage biopharmaceutical company, has filed an Investigational New Drug Application (IND) with the FDA to initiate clinical trials evaluating OMS824, the company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.

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Orexo submits NDA for Zubsolv for opiod dependence

Friday, September 7, 2012 01:41 PM

Orexo, an emerging specialty pharmaceutical company, has submited a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans.

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