Clinical Intelligence

Study links coffee, genetics and Parkinson's disease prevention

Monday, February 6, 2012 02:30 PM

A recent study co-authored by Evergreen Healthcare neurologist Dr. Pinky Agarwal finds good news for coffee drinkers: consuming caffeinated coffee may significantly reduce the risk of Parkinson's disease in some individuals depending on their genetics, according to research recently published by the Public Library of Science.

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Inherited risk factors for childhood leukemia more common in Hispanic patients

Monday, February 6, 2012 02:19 PM

Hispanic children are more likely than those from other racial and ethnic backgrounds to be diagnosed with acute lymphoblastic leukemia (ALL) and are more likely to die of their disease, found a study conducted by the Children’s Oncology Group and St Jude Children’s Hospital.

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Henry Ford Hospital first in U.S. to start trial in aggressive brain tumors

Monday, February 6, 2012 02:12 PM

Henry Ford Hospital's Hermelin Brain Tumor Center is the first U.S. hospital to start a new clinical trial for Toca 511 & Toca FC, a combination therapy under investigation for high-grade glioma (HGG), a fast growing, brain cancer that often recurs even after surgery, radiation treatment and chemotherapy.

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Bayer initiates expanded access program for radium-223 chloride

Monday, February 6, 2012 02:11 PM

The FDA has approved of Bayer Healthcare proceeding with its expanded access program to provide the investigational drug radium-223 chloride to patients diagnosed with castration-resistant prostate cancer (CRPC) and hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases.

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Alize licenses Asparec therapy for treatment of leukemia

Monday, February 6, 2012 02:08 PM

Alize Pharma II, a drug development company focused on oncology and metabolism and part of the Alize Pharma group, has signed a license agreement with EUSA Pharma for Asparec, a new L-asparaginase product currently in phase I clinical development for the treatment of acute lymphoblastic leukemia.

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FDA approves Kalydeco to treat rare form of cystic fibrosis

Friday, February 3, 2012 01:46 PM

The FDA has approved Kalydeco (ivacaftor), manufactured by Vertex Pharmaceuticals, for the treatment of a rare form of cystic fibrosis in patients ages six and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

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FDA removes partial hold on Idenix HCV nucleotide inhibitor

Friday, February 3, 2012 01:43 PM

The FDA has lifted the partial clinical hold on Idenix Pharmaceutical’s IDX184, a hepatitis C virus (HCV) nucleotide inhibitor. The action allows Idenix to continue its 12-week phase IIb study evaluating the drug in combination with pegylated interferon and ribavirin (PegIFN/RBV).

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The CenterWatch Monthly, February 2012

Friday, February 3, 2012 12:01 PM

Anticipating the rise of virtual drug development

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FDA approves Gleevec for rare gastrointestinal cancer

Thursday, February 2, 2012 08:32 AM

The FDA has granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST).

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Affinium doses first patient with oral AFN-1252 for skin infections

Wednesday, February 1, 2012 04:04 PM

Affinium Pharmaceuticals has dosed its first patient in a multi-center phase II clinical trial evaluating oral AFN-1252 in acute bacterial skin and skin structure infections. The phase II trial is the first human efficacy study conducted with this new class of antibiotic and follows the recently completed phase I trials, which demonstrated excellent safety, tolerability and pharmacokinetics of AFN-1252 in single and multiple ascending oral dosages.

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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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