Clinical Intelligence

FDA approves Perjeta for HER2-positive metastatic breast cancer

Monday, June 11, 2012 03:03 PM

The FDA has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

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Novartis’ Gilenya earns positive results in extended phase III head-to-head study

Monday, June 11, 2012 02:52 PM

New long-term data for Gilenya (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment, according to Switzerland-based Novartis Pharma.

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Mount Sinai researchers develop multi-target approach to treating tumors

Friday, June 8, 2012 02:38 PM

Researchers from Mount Sinai School of Medicine developed a cancer model built in the fruit fly Drosophila, then used it to create a whole new approach to the discovery of cancer treatments: AD80.

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Generex touts positive AE37 cancer vaccine technology

Friday, June 8, 2012 11:56 AM

Generex Biotechnology reported promising technology and clinical results from its on-going phase II trial of the AE37 breast cancer vaccine being developed by its subsidiary Antigen Express.

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Two GSK melanoma drugs garner top results

Monday, June 4, 2012 10:21 AM

GlaxoSmithKline released results from two of its phase III melanoma studies: one evaluating single agent therapy with the targeted anti-cancer agents, dabrafenib and trametinib, in patients with BRAF V600 mutation positive metastatic melanoma; and one evaluating trametinib alone.

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Ocera drug rapidly reduces ammonia in liver cirrhosis trial

Friday, June 1, 2012 11:10 AM

Ocera Therapeutics of San Diego and the Hospital Universitari Vall d'Hebron Research Institute in Barcelona released preliminary data from an open label phase II study evaluating the overall effectiveness and safety of OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis of the liver and upper GI bleeding.

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Novelos completes first cohort in phase Ib solid tumor trial

Friday, June 1, 2012 10:59 AM

Novelos Therapeutics, a Madison, Wis.-based pharmaceutical company focused on cancer, has successfully completed the first cohort in a multi-center phase Ib dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors. 

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The CenterWatch Monthly, June 2012

Friday, June 1, 2012 09:00 AM

Western Europe sees drop in active investigators

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Flexion touts positive phase II results for osteoarthritis drug

Thursday, May 31, 2012 12:30 PM

Flexion Therapeutics of Woburn, Mass., has released results from the phase II proof-of-concept trial of its lead osteoarthritis drug candidate, FX005, which demonstrated significant pain relief over placebo at four weeks.

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Lilly reports positive data in phase II diabetes study of dulaglutide

Friday, May 25, 2012 01:16 PM

Eli Lilly’s investigational drug dulaglutide, a long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes, met its primary endpoint of non-inferiority for mean 24-hour systolic blood pressure (SBP, or pressure while the heart contracts) after 16 weeks.

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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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The CenterWatch Monthly

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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