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Clinical Intelligence

Upsher-Smith receives FDA approval for Qudexy XR (topiramate)

Thursday, March 13, 2014 11:15 AM

Upsher-Smith Laboratories has received FDA approval for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures.  It also is approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients in the second quarter of 2014.

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CRF Health eCOA webinar series

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.

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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.

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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).

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The CenterWatch Monthly, March 2014

Monday, March 3, 2014 08:00 AM

Strategic alliances hit bumps in the road

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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.

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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.

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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. 

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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.   

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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.  

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

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March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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