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Clinical Intelligence

FDA approves IDE for VENITI VICI Venous Stent System

Monday, July 14, 2014 01:33 PM

Veniti, a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.

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Health Canada approves APTIOM (eslicarbazepine acetate) for epilepsy

Monday, July 14, 2014 01:13 PM

Sunovion Pharmaceuticals Canada has announced that Health Canada approved APTIOM (eslicarbazepine acetate) for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. APTIOM is not indicated for use in patients under 18 years of age.

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CardioCell begins phase IIa trial using itMSC therapy for chronic heart failure

Thursday, July 10, 2014 02:37 PM

CardioCell, a Stemedica Cell Technologies subsidiary that creates allogeneic stem-cell therapies for cardiovascular indications, has started its phase IIa clinical trial for chronic heart failure (HF) patients with non-ischemic cardiomyopathy.

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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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November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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