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Clinical Intelligence

Astellas receives FDA approval of ASTAGRAF XL

Wednesday, July 24, 2013 10:15 AM

Astellas Pharmasaid the FDA has approved ASTAGRAF XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

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Scientists find 3D structure of key drug target for diabetes

Wednesday, July 24, 2013 09:24 AM

An international team led by scientists at The Scripps Research Institute (TSRI), an independent, nonprofit organization focused on research in the biomedical sciences, has determined and analyzed the three-dimensional atomic structure of the human glucagon receptor. The receptor, found mainly on liver and kidney cells, helps regulate glucose levels in the bloodstream and is the target of potential therapeutic agents for type 2 diabetes.

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Anti-TNF infusion therapy approved for RA patients

Friday, July 19, 2013 01:20 PM

The FDA has approved Janssen Biotech’s Simponi Aria (golimumab) infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. Simponi Aria, the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, has been shown to improve signs, symptoms and physical function and inhibit the progression of structural damage.

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Trevena granted composition of matter patent for TRV027

Thursday, July 18, 2013 11:05 AM

Trevena, a clinical stage pharmaceutical company in the discovery and development of G-protein coupled receptor (GPCR) biased ligands, said the U.S. Patent and Trademark Office has granted Trevena a composition of matter patent covering its development product TRV027.

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Ultragenyx gains worldwide rights for Triheptanoin

Thursday, July 18, 2013 09:30 AM

Ultragenyx, a privately held, clinical-stage biotechnology company, has expanded its exclusive license from Baylor Research Institute (BRI) in Dallas, Texas, to develop and commercialize triheptanoin outside North America. The global license includes rights to patents, patent applications and other intellectual property related to the composition and formulation of UX007, as well as its use in treating diseases including fatty acid oxidation disorders (FAOD), the lead indication being developed by the company.

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Pharmacyclics submits NDA for Ibrutinib

Tuesday, July 16, 2013 11:36 AM

Pharmacyclics, a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases, based in Sunnyvale, Calif., has submitted a New Drug Application (NDA) to the FDA for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

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BNA, JPNI among 30 sites in ACADIA clinical trial

Monday, July 15, 2013 01:35 PM

Boulder Neurosurgical & Spine Associates (BNA) and the Justin Parker Neurological Institute (JPNI) are among approximately 30 sites in the U.S. participating in the ACADIA clinical trial. The trial seeks to evaluate the safety and efficacy of the ACADIA Facet Replacement System, an investigational device for treatment of lumbar spinal stenosis (LSS).

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Asubio broadens inclusion criteria for spinal cord injury trial

Thursday, July 11, 2013 10:00 AM

Asubio Pharmaceuticals has expanded enrollment for its ASCENT-ASCI (Asubio Spinal Cord Early Neuro-recovery Treatment for Acute Spinal Cord Injury) trial to include AIS A, B and C injury to the cervical spine. ASCENT-ASCI is a phase II clinical trial evaluating SUN13837, an investigational medication being developed to improve neurological function in patients with newly diagnosed acute spinal cord injury.

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Curetis initiates prospective multicenter Unyver study in Europe

Thursday, July 11, 2013 08:30 AM

Curetis has started an additional prospective, multicenter trial of its marketed Unyver P50 Pneumonia Application to demonstrate its clinical and health economic value.

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Neurocrine completes study enrollment

Tuesday, July 9, 2013 01:37 PM

Biopharmaceutical Neurocrine Biosciences has completed recruitment in the phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The final subject will randomize this week.

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April 14

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

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

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

Tapping community hospitals for clinical trial volunteers
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