Clinical Intelligence

bluebird bio completes NIH review, moved forward with trial against recommendation

Thursday, June 11, 2015 12:34 PM

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, has completed the NIH Recombinant DNA Advisory Committee's (RAC) public review of the HGB-208 pediatric study protocol for bluebird bio's LentiGlobin BB305 product candidate in beta-thalassemia major. The RAC recommendation was to delay initiation of the study in the U.S. for one to two years. This recommendation has no effect on the HGB-207 protocol plan.

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Retrophin receives FDA Fast Track for pantothenate kinase-associated neurodegeneration

Friday, June 5, 2015 11:14 AM

The FDA has granted Fast Track designation for RE-024, the Retrophin’s novel investigational phosphopantothenate replacement therapy, for the treatment of pantothenate kinase-associated neurodegeneration (PKAN).

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FDA approves Cipla’s Lopinavir/ritonavir for AIDS in infants and young children

Thursday, June 4, 2015 01:18 PM

Cipla, a global pharmaceutical company, has received FDA approval for Lopinavir/ritonavir (LPV/r) 40mg/10mg oral pellets for paediatric specific treatment for infants.

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Merck, Dynavax collaborate on immuno-oncology therapies

Thursday, June 4, 2015 01:02 PM

Merck & Co. and Dynavax Technologies have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from both companies' pipelines: Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator, MK-1966, with Dynavax's investigational toll-like receptor 9 (TLR9) agonist, SD-101.

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The CenterWatch Monthly, June 2015

Monday, June 1, 2015 08:00 AM

TransCelerate Biopharma turns three

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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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CWWeekly

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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