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Clinical Intelligence

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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FDA approves Bayer's Gadavist Injection for breast cancer

Thursday, June 12, 2014 12:41 PM

The FDA has approved a new indication for Bayer Healthcare’s Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two, multi-center, phase III studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.

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FDA approves antihemophilic factor, Fc fusion protein hemophilia A

Thursday, June 12, 2014 11:33 AM

The FDA has approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. Eloctate is the first hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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BioDelivery Sciences receives FDA approval for BUNAVAIL for opioid dependence

Monday, June 9, 2014 10:24 AM

BioDelivery Sciences International has received approval of the NDA for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) from the FDA. BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

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Caris Life Sciences shows positive results for comprehensive tumor profiling

Friday, June 6, 2014 02:06 PM

Data from more than 30 clinical has reinforce comprehensive tumor profiling as a “game changer” for oncologists, enabling them to personalize cancer treatments more precisely than ever before. The studies, conducted by Caris Life Sciences in cooperation with academic and clinical institutions, focused on treatment-resistant, rare or aggressive cancers where patients have limited treatment options.

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November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

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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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