Clinical Intelligence

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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BrainStorm finds NurOwn interim phase results promising

Tuesday, January 24, 2012 10:26 AM

Data from the initial patients in BrainStorm Cell Therapeutics’ ALS (Lou Gehrig’s Disease) phase I/II human clinical trial treated with its NurOwn technology showed it did not present any significant side effects and the NurOwn treatment has so far proven to be safe, according to BrainStorm.

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CWWeekly

May 21

Parexel consultant testifies on FDA biosimilars guidance

Global Telecom Testing checks ex-U.S. toll-free phone lines for multinational clinical trials

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CWWeekly

May

Newer sites most optimistic about the future
Investigative sites of all sizes, from part-time physician-run sites to large dedicated research centers, report a rebound in operating conditions, according to a new CenterWatch analysis, yet sites from each subgroup indicate they have concerns…

Risk-based monitoring slow to catch on with industry
It's estimated that the cost of physically sending monitors to all investigative sites at regular intervals, a model the industry itself developed and has adhered to for about a decade, eats up one-third to one-half of…

Eye On Millennium
Millennium, The Takeda Oncology Company, discovers and develops novel treatments applying world-class recombinant technology to a wide variety of oncology disease targets…

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