Clinical Intelligence

Lutonix enrolls first patient in LEVANT 2 trial

Friday, July 29, 2011 10:32 AM

Lutonix has enrolled its first patient in the LEVANT 2 clinical trial, a global, multi-center, randomized trial evaluating the safety and efficacy of the Moxy(TM) Drug Coated Balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD).  The first case was performed at St. John's Hospital in Springfield, Ill., by Dr. Jeff Goldstein.

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FDA approves Wiskott Aldrich gene therapy trial

Friday, July 29, 2011 10:29 AM

The FDA approved the launching in the U.S. of a clinical trial for gene therapy for a rare immunodeficiency, Wiskott-Aldrich syndrome (WAS). After its implementation in Paris and London, this trial based on preclinical research performed at Genethon (Evry, France) which also manufactures the GMP gene therapy product, is now going to be launched in Boston. It's one of the first international clinical trials using a gene therapy treatment for a rare disease.

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FDA advisory committee recommends REMICADER

Friday, July 29, 2011 10:13 AM

Janssen Biotech, formerly Centocor Ortho Biotech, reported the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA recommended the approval of REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

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CSL, Selexis ink commercial license agreement

Wednesday, July 27, 2011 01:12 PM

Australia-based CSL has entered into a commercial license agreement with Selexis, headquartered in Switzerland, for the pre-clinical development of a therapeutic antibody anticipated to enter phase I clinical trials in 2012. This commercial license agreement provides CSL with the rights to use a cell line, generated using the Selexis SUREtechnology Platform, for the cGMP production of an undisclosed antibody.

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FDA approves XEOMINR

Friday, July 22, 2011 10:19 AM

Merz Aesthetics said the FDA has approved XEOMINR (incobotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.

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Boosted REYATAZ proves effective in men and women

Friday, July 22, 2011 10:16 AM

Bristol-Myers Squibb released results from a long-term European cohort study that included 1,294 antiretroviral (ARV)-experienced patients from Germany, France and Sweden.

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Cellectis, Lonza reach milestone with CHO-K1SV GS

Friday, July 22, 2011 10:14 AM

Cellectis bioresearch and Lonza have reached a significant milestone in the development of a newly bioengineered cell line.

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Aeterna Zentaris to present phase II AEZS-108 results

Wednesday, July 20, 2011 11:25 AM

Aeterna Zentaris will present the final phase II  results in endometrial cancer on its anticancer compound, AEZS-108, during a poster session at the upcoming 17th International Meeting of the European Society of Gynaecological  Oncology ("ESGO"), Sept. 11-14 in Milan, Italy.

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Lilly releases Alzheimer’s research results

Wednesday, July 20, 2011 11:18 AM

Lily presented data from the first of two phase III trials of semagacestat, including data from a 32-week follow-up period after dosing was halted in August 2010.

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QRxPharma files NDA for MoxDuoR IR

Wednesday, July 20, 2011 11:16 AM

QRxPharma reported the initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the FDA.

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