Clinical Intelligence

CluePoints announces U.S patent allowance for SMART Engine

Monday, May 18, 2015 02:33 PM

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that the U.S. Patent and Trademark Office has granted a Notice of Allowance for Application No. 13/452,338, a patent which covers the company's SMART engine. The patent provides broad coverage for CluePoints' proprietary methodology that supports a risk-based approach to data monitoring in clinical trials.

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West Nile virus vaccine now in phase I clinical trials

Thursday, May 14, 2015 10:48 AM

A novel investigational West Nile virus vaccine discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University is being evaluated in an NIH-sponsored phase I, first-in-human, clinical trial at Duke University. Although several early-stage West Nile virus vaccine clinical trials have been completed to date, no human vaccine has been approved for commercial use.

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23andMe launches Lupus research study in collaboration with Pfizer

Thursday, May 14, 2015 10:19 AM

23andMe, a personal genetics company based in Mountain View, Calif., has launched the Lupus Research Study in collaboration with Pfizer. The companies aim to enroll 5,000 individuals with systemic lupus erythematosus, more commonly known as lupus, into the study to help better understand the genetics of lupus. The effort also is in collaboration with the Lupus Research Institute and in concert with Lupus Awareness Month in May.

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FDA lifts clinical hold on NeuroDerm’s ND0612 for Parkinson's

Monday, May 11, 2015 10:30 AM

The FDA has lifted the clinical hold on U.S. clinical studies of ND0612H and ND0612L, primary product candidates based on proprietary, subcutaneously-delivered Levodopa/Carbidopa (LD/CD) liquid formulation for the treatment of Parkinson's disease, owned by NeuroDerm, a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases. The hold was lifted after the FDA reviewed additional information related to the product candidates' delivery devices. U.S. clinical development of these product candidates is therefore cleared to proceed in the second half of 2015.

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ViiV Healthcare begins phase III dolutegravir/rilpivirine program for HIV maintenance therapy

Thursday, May 7, 2015 01:03 PM

ViiV Healthcare has started a phase III clinical trial program to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV. The phase III program comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who already have achieved viral suppression with a three drug regimen.

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AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015 12:54 PM

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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CytRx’s Aldoxorubicin shows improved QoL in chemotherapy resistant cancers

Monday, May 4, 2015 02:33 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced an interim analysis from its two ongoing phase Ib aldoxorubicin combination studies pairing aldoxorubicin with either gemcitabine or ifosfamide. Both studies combine standard doses of gemcitabine or ifosfamide with escalating doses of aldoxorubicin. The combinations appear to be well-tolerated, and even at the lowest dose level of aldoxorubicin (170mg/m2), impressive tumor responses have been observed so far in patients with bone cancer (osteosarcoma) and a variety of soft tissue sarcomas. As such, aldoxorubicin has the potential when used in combination with other cancer agents to become an important new weapon against chemotherapy resistant cancers.

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Phase I ALS trial shows positive results for stem cell therapy

Monday, May 4, 2015 12:58 PM

Hanyang University and Corestem, both in Seoul, South Korea, and Inje University College of Medicine in Busan released positive results in a phase I clinical trial for amyotrophic lateral sclerosis (ALS).

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The CenterWatch Monthly, May 2015

Friday, May 1, 2015 08:00 AM

Job satisfaction mixed as workload increases

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PTC Therapeutics' cancer stem cell program targeting BMI1 enters phase I

Thursday, April 30, 2015 11:45 AM

PTC Therapeutics has announced that its oncology program targeting BMI1, a protein linked to drug-resistant cancers, has entered a phase I study in patients with advanced solid tumors. The open-label, first-in-human study will investigate the safety and pharmacokinetics of PTC596, an orally available small molecule. PTC's BMI1 program is supported by a collaboration with the Wellcome Trust.

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July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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