Clinical Intelligence

Janssen, Bayer initiate anticoagulant rivaroxaban trials

Friday, May 29, 2015 01:54 PM

Janssen Pharmaceuticals and its development partner, Bayer HealthCare, have initiated CALLISTO, a new comprehensive clinical research program for their novel oral anticoagulant, rivaroxaban, in patients with active cancer. The studies are evaluating the medicine for the prevention and treatment of life-threatening blood clots in patients with a wide range of cancer types.

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Amgen releases phase III AMG 416 data for secondary hyperparathyroidism in CKD

Friday, May 29, 2015 01:46 PM

Amgen has released pooled data from two pivotal phase III, global, randomized, placebo-controlled trials evaluating AMG 416, a novel calcimimetic, for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis. Both studies met the primary endpoint, demonstrating that a greater proportion of patients in the AMG 416 groups achieved a greater than 30% reduction in parathyroid hormone (PTH) during the efficacy assessment phase compared with placebo.

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Actavis receives FDA approval for Viberzi (eluxadoline) for adult IBS-D

Thursday, May 28, 2015 03:01 PM

Actavis’ Viberzi (eluxadoline) has been approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist.

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York U Researchers to look for patterns in patient data from ManagingLife's pain diary app

Thursday, May 21, 2015 02:51 PM

A digital journal of pain occurrences maintained by the users of an innovative app, Manage My Pain, will be the key source for their upcoming study, said York University psychology researchers. The app's developer ManagingLife, a privately held mobile tool developer based in Toronto, Canada, will provide the large database to York U in a collaborative effort.

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FDA approves Invega Trinza, only four-times-a-year treatment for schizophrenia

Thursday, May 21, 2015 02:27 PM

The FDA has approved under Priority Review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Priority Review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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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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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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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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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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