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Clinical Intelligence

Amgen receives FDA Breakthrough Therapy Designation for Blinatumomab in ALL

Wednesday, July 2, 2014 11:04 AM

The FDA has granted Breakthrough Therapy Designation to Amgen’s investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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The CenterWatch Monthly, July 2014

Tuesday, July 1, 2014 07:00 AM

IRB market consolidating rapidly

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FDA approves Afrezza to treat diabetes

Monday, June 30, 2014 02:29 PM

The FDA has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal.

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U.S. Oncology Research launches trial for preventing chemotherapy-induced hair loss

Monday, June 30, 2014 01:01 PM

U.S. Oncology Research—one of the largest community-based cancer research programs in the nation—and Baylor College of Medicine recently have launched a clinical trial to study a scalp cooling system designed to prevent chemotherapy-induced hair loss (alopecia). To date, 15 patients have been enrolled, and the study now is available at three U.S. Oncology Research sites.

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Ampio Pharmaceuticals closes enrollment in the OptimEyes study

Friday, June 27, 2014 01:54 PM

Ampio Pharmaceuticals has informed the Transplant and Ophthalmology Division of the FDA of its intent to reduce the patient sample size in the OptimEyes study for the treatment of diabetic macular edema (oral treatment with Optina). This trial was intended to enroll 450 patients and was powered at 95%. The present enrollment of over 355 patients provides an adequate power of 88%, which the company believes is more than sufficient for statistical evaluation.

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Aurinia Pharmaceuticals initiates phase IIb trial of Voclosporin for lupus nephritis

Friday, June 27, 2014 01:19 PM

Aurinia Pharmaceuticals has enrolled the first patient in its planned phase IIb clinical trial to evaluate the efficacy of voclosporin as a treatment for lupus nephritis (LN). LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition. The Lupus Foundation of America believes there are as many as 1.5 million people in the U.S. with systemic lupus erythematosus (SLE), approximately 40% to 70% of whom will develop LN.

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FDA approves Sivextro to treat skin infections

Thursday, June 26, 2014 03:02 PM

The FDA has approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.

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Bellerophon completes enrollment for phase II trial of INOpulse for PAH

Thursday, June 19, 2014 02:46 PM

Bellerophon Therapeutics, a clinical stage biotherapeutics company has completed enrollment of its 80-patient phase II clinical trial of INOpulse for the treatment of pulmonary arterial hypertension (PAH). PAH is a life-threatening, progressive disorder characterized by abnormal constriction of the arteries of the lung, leading to increased blood pressure in the lungs and abnormal strain on the heart's right ventricle, eventually leading to heart failure.

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Debiopharm Group initiates phase I study of Debio 1450 for staphylococcal infections

Thursday, June 19, 2014 02:16 PM

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, has launched a phase I dose-escalation study of Debio 1450 (previously known as AFN-1720), a highly potent anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).

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Amgen joins NCI to accelerate development of personalized cancer treatments

Tuesday, June 17, 2014 10:26 AM

Amgen will collaborate with the National Cancer Institute (NCI), part of the NIH, and other public and private sector partners, on the Lung Master Protocol (Lung-MAP), a new clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets under one trial protocol.

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