Clinical Intelligence

Auxilium doses first patients in phase Ib cellulite study

Friday, January 27, 2012 02:10 PM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company, said the first cohort of patients has been dosed in its phase Ib trial of Xiaflex (collagenase clostridium histolyticum) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.

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Infinity halts phase II pancreatic cancer study

Friday, January 27, 2012 02:04 PM

After analyzing interim data, Infinity Pharmaceuticals has stopped its phase II study comparing saridegib (IPI-926) in combination with gemcitabine to a placebo plus gemcitabine as treatment for metastatic pancreatic cancer.

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Interim data released on phase I Adcetris trial

Friday, January 27, 2012 02:01 PM

Seattle Genetics and Millennium, the Takeda oncology company, released interim results from 32 patients treated to date in a phase I clinical trial of Adcetris (brentuximab vedotin) administered in combination or sequentially with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (sALCL) and other CD30-positive mature T-cell lymphoma patients.

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Cohera receives IDE approval to begin TissuGlu U.S. trial

Thursday, January 26, 2012 01:24 PM

Cohera Medical, a developer of absorbable surgical adhesives and sealants, has received Investigational Device Exemption (IDE) approval from the FDA to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu Surgical Adhesive in the U.S.

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FDA grants Fast Track designation to Neurocrine Biosciences

Thursday, January 26, 2012 10:17 AM

The FDA has granted Neurocrine Biosciences Fast Track designation for its VMAT2 inhibitor product candidate NBI-98854, for the treatment of neuroleptic-induced tardive dyskinesia.

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Oramed granted Australian patent for core technology

Thursday, January 26, 2012 09:10 AM

Marking a major milestone for the company, Oramed Pharmaceuticals, a developer of oral drug delivery systems, has received approval for a key patent by the Australian Patent Office. The patent covers an important part of Oramed's core technology, which allows for the oral delivery of peptides.

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FDA approves LEO Pharma’s Picato gel

Wednesday, January 25, 2012 04:21 PM

The FDA has approved LEO Pharma’s Picato (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK), a precancerous condition caused by cumulative sun exposure.

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Study finds Gardasil does not trigger lupus, type I diabetes

Wednesday, January 25, 2012 04:19 PM

Gardasil, the HPV vaccine recommended for male and female adolescents and young adults, does not trigger autoimmune conditions such as lupus, type 1 diabetes or multiple sclerosis after vaccination in young women, according to a new study in the Journal of Internal Medicine, conducted by Kaiser Permanente.

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Shinogi’s Cuvposar reduced chronic severe drooling

Wednesday, January 25, 2012 04:15 PM

Therapeutics and Clinical Risk Management online journal published Shinogi’s promising results from two studies on Cuvposar, the first and only FDA-approved treatment to reduce chronic severe drooling in patients ages 3-16 with neurologic conditions associated with chronic drooling.

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Aphios awarded SBIR grant for Alzheimer’s research

Wednesday, January 25, 2012 04:12 PM

Aphios has received a phase II SBIR grant from the National Institutes of Health (NIH) for $2.4 million over two years. The National Institute on Aging (NIA), part of the NIH, awarded the grant to Aphios to develop an “Alzheimer’s Disease Therapeutic.

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