Clinical Intelligence

Northwest Bio gets OK for phase III brain cancer trial in the U.K.

Friday, August 24, 2012 09:00 AM

Northwest Biotherapeutics, a Bethesda, Md.-based biotech, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the U.K. to proceed with the company's 300-patient phase III clinical trial of DCVax-L immune therapy for Glioblastoma multiforme brain cancer (GBM).

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Common antifungal drug decreases tumor growth, shows promise as cancer therapy

Wednesday, August 22, 2012 10:18 AM
An inexpensive antifungal drug, thiabendazole, slows tumor growth and shows promise as a chemotherapy for cancer, according to scientists in the College of Natural Sciences at The University of Texas at Austin.

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FDA green lights first cord blood stem cell trial in autism

Tuesday, August 21, 2012 11:38 AM

Sutter Neuroscience Institute, a recognized Center of Excellence in Sacramento, Calif., and the Cord Blood Registry (CBR), the world's largest stem cell bank, are launching the first FDA-approved clinical trial to assess the use of a child's own cord blood stem cells to treat select patients with autism. 

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ThromboGenics publishes phase III data of ocriplasmin for VMT

Friday, August 17, 2012 03:11 PM

ThromboGenics, a Belgium-based biopharmaceutical company focused on ophthalmic medicines, has published data from two phase III clinical trials evaluating ocriplasmin for the treatment of Vitreomacular Adhesion (VMA) and macular holes in the New England Journal of Medicine.

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Enzalutamide adds 5 months survival in late-stage prostate cancer

Friday, August 17, 2012 02:52 PM

Results of a phase III clinical trial of the drug Enzalutamide, recently published in the New England Journal of Medicine, show the drug extends life by an average five months in the most advanced stages of prostate cancer.

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FDA approves first generic Actos to treat type 2 diabetes

Friday, August 17, 2012 02:33 PM

The FDA has approved the first generic version of Actos (pioglitazone hydrochloride) tablets, used in conjunction with diet and exercise to improve blood glucose control in adults with type 2 diabetes. Mylan Pharmaceuticals, based in Morgantown, W.V., gained FDA approval for 15mg, 30mg and 45mg pioglitazone tablets.

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FDA approves Lucentis for diabetic macular edema

Monday, August 13, 2012 10:33 AM

The FDA has approved Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

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FDA approves Marqibo for rare type of leukemia

Thursday, August 9, 2012 02:56 PM

The FDA approved Talon Therapeutics’ Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL), a rapidly progressing form of blood and bone marrow cancer that is more commonly diagnosed in children than adults.

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Lightlake Therapeutics touts positive phase II results of binge eating disorder

Thursday, August 9, 2012 11:23 AM

Lightlake Therapeutics, an early stage biopharmaceutical company developing modern addiction treatments, released final data from a phase II study of its proprietary opioid antagonist naloxone nasal spray treatment for patients with binge eating disorder (BED).

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FDA approves Zaltrap for metastatic colorectal cancer

Monday, August 6, 2012 12:51 PM

The FDA has approved Sanofi-Aventis’ Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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