Clinical Intelligence

Merck’s investigational HIV therapy Doravirine demonstrates antiviral activity

Friday, March 7, 2014 10:01 AM

Merck has presented data from the dose-ranging portion of an ongoing phase IIb clinical trial of doravirine, the company’s investigational next-generation, non-nucleoside reverse transcriptase inhibitor (NNRTI). Interim data demonstrating potent antiretroviral (ARV) activity for four doses of once-daily, oral doravirine in combination with tenofovir/emtricitabine in treatment-naïve, HIV-1 infected adults after 24 weeks of treatment were presented during a late-breaker oral session. Based on these findings as well as other data from the doravirine clinical program, Merck plans to initiate a phase III clinical trial program for doravirine in combination with ARV therapy in the second half of 2014.

More... »

WIRB Copernicus Group

FDA approves AVEED injectable testosterone replacement therapy

Thursday, March 6, 2014 08:51 AM

Endo Pharmaceuticals, a global specialty healthcare company, has received FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

More... »


MEI Pharma receives Orphan status for AML treatment Pracinostat

Monday, March 3, 2014 11:16 AM

MEI Pharma, a San Diego-based oncology company focused on the clinical development of novel therapies for cancer, has announced that the FDA has granted orphan drug designation to the company's investigational drug Pracinostat for the treatment of acute myeloid leukemia (AML).

More... »

The CenterWatch Monthly, March 2014

Monday, March 3, 2014 08:00 AM

Strategic alliances hit bumps in the road

More... »

Parkinson's Biomarker initiative expands study of genetics

Friday, February 28, 2014 11:47 AM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by The Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with genetic mutations associated with Parkinson's disease (PD). Researchers hope that greater understanding of the biology and clinical features of these participants—people with or at risk to develop Parkinson's—will lead to therapeutics that would help all Parkinson's patients and ultimately provide strategies to prevent disease onset.

More... »

Sinovac's EV71 vaccine produces positive phase III clinical trial results

Friday, February 28, 2014 11:35 AM

Sinovac Biotech, a provider of biopharmaceutical products in China, has announced that Phase III clinical trial results for its proprietary Enterovirus 71 (EV71) vaccine have been published online in the February 27 issue of TheNew England Journal of Medicine (NEJM). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease (HFMD), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

More... »

FDA approves Myalept to treat rare metabolic disease

Wednesday, February 26, 2014 11:42 AM

The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. 

More... »

Berg, the Parkinson's Institute partner for clinical development

Friday, February 21, 2014 02:08 PM

Berg and the Parkinson's Institute and Clinical Center have announced the next phase in their ongoing partnership, focused on identifying potential biomarkers that may lead to breakthroughs in the research, diagnosis, and treatment of Parkinson's disease. Using Berg's Interrogative Biology platform to analyze multi-omic tissue samples (skin fibroblasts, blood, urine) supplied by the Parkinson's Institute, this collaboration will identify the differences between healthy and diseased tissues in an effort to unravel the mysteries of Parkinson's disease. Berg and the Parkinson's Institute together are the first teams to approach biomarker discovery by looking at proteomics, metabolomics, and lipidomics, in addition to clinical data, simultaneously in human patients and controls from the same cohort.   

More... »

FDA approves Northera to treat neurogenic orthostatic hypotension

Wednesday, February 19, 2014 03:53 PM

The FDA has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure.  

More... »

CardioCell launches two new acute myocardial infarction trials

Wednesday, February 19, 2014 03:11 PM

CardioCell, a global biotechnology company that explores therapeutic applications of unique, patented, ischemia-tolerant mesenchymal stem cells (itMSCs) manufactured under cGMP conditions, announces two new clinical trials using its allogeneic stem-cell therapy to treat subjects with acute myocardial infarction (AMI), a problem facing more than 1.26 million Americans annually. In the U.S., CardioCell is initiating a phase IIa AMI clinical trial to evaluate the clinical safety and efficacy of its itMSCs. In addition, the Ministry of Health in Kazakhstan is beginning a phase III AMI clinical trial on the intravenous administration of CardioCell’s itMSCs, based on the efficacy and safety found in phase II clinical trials.

More... »

Subscribe to The CenterWatch Monthly
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

Already a subscriber?
Log in to your digital subscription.

Purchase the July issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs