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Clinical Intelligence

FDA approves Imbruvica for rare blood cancer

Wednesday, November 13, 2013 04:13 PM

The FDA has approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.

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CRF Health eCOA webinar series

Alexion presents positive results from four trials of Soliris (eculizumab)

Tuesday, November 12, 2013 09:00 AM

Alexion Pharmaceuticals has announced that researchers presented data from  four clinical trials, all demonstrating the clinical benefits of Soliris (eculizumab) for the treatment of atypical hemolytic uremic syndrome (aHUS), a genetic, chronic, ultra-rare disease associated with vital  organ failure and premature death. Soliris is the first and only approved safe and effective treatment for pediatric and adult patients with aHUS. In two large, prospective, multinational studies, Soliri inhibited systemic complement-mediated thrombotic microangiopathy (TMA, the formation of blood clots in small blood vessels throughout the body) and improved renal function in both pediatric and adult patients with aHUS. The data were presented at Kidney Week 2013, the annual meeting of the American Society of Nephrology (ASN).

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OncoMed earns $15 million milestone payment from Bayer

Wednesday, November 6, 2013 03:44 PM

OncoMed Pharmaceuticals, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, has earned a $15 million milestone payment from Bayer Pharma related to achieving a dose escalation milestone in the phase Ia clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway. 

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Soterix Medical announces phase III trial for depression

Tuesday, November 5, 2013 10:02 AM

Soterix Medical has announced a phase III trial for Major Depressive Disorder (MDD), which will compare Soterix Medical's Transcranial Direct Current Stimulation (tDCS) Limited Total Energy (LTE) technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro). The seminal ELECT-TDCS study, initiated by Dr. Andre Brunoni of the University of Sao Paulo, builds on prior work. This work combined tDCS with antidepressant sertraline and concluded "in MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ."

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Enlivex Therapeutics’ positive results from phase I/II bone marrow transplant trial

Tuesday, November 5, 2013 09:00 AM

Enlivex Therapeutics has published a scientific paper in the American Society for Blood and Marrow Transplantation titled “Biology of Blood and Marrow Transplantation.”

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The CenterWatch Monthly, November 2013

Friday, November 1, 2013 09:41 AM

AMCs show renewed interest in industry research

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VisionGate Cell-CT 3D imaging platform detects lung cancer

Tuesday, October 29, 2013 11:04 AM

VisionGate, a developer of a non-invasive test for the early detection of lung cancer, has reported clinical data showing that its automated 3D cell imaging platform, the Cell-CT, can detect lung cancer in sputum samples with high sensitivity and specificity.

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AB-Biotics acquires patent for predicting antipsychotic-induced extrapyramidal symptoms

Tuesday, October 29, 2013 10:00 AM

The Spanish biotech company AB-Biotics has acquired the rights to a patent which predicts the high or low risk of a patient treated with antipsychotic drugs developing extrapyramidal symptoms. Side effects induced by antipsychotic drugs affect patient movement and include muscle rigidity, parkinsonism, akinesia (inability to initiate movement) and akathisia (inability to remain motionless).

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Palatin Technologies reports successful completion of device bioequivalence trial

Tuesday, October 29, 2013 09:00 AM

Palatin Technologies has announced the successful completion of a clinical trial designed to demonstrate equivalence of subcutaneously administered bremelanotide via autoinjector compared to pre-filled syringe administration. Bioequivalence was achieved in this clinical trial. Palatin used pre-filled syringes in its phase II clinical trials, but will use the single-dose disposable autoinjector in its planned phase III clinical trials and for commercialization.

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FDA approves Actelion's Opsumit for pulmonary arterial hypertension

Monday, October 21, 2013 12:53 PM

The FDA has approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.

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Healthcare IPOs soar in first quarter

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Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

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Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
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