FDA

Cetero says FDA’s actions ‘difficult to understand’—company notified agency of chemists’ misconduct

Monday, August 1, 2011 08:02 AM

Large, early-phase CRO Cetero Research seemed blindsided by the FDA’s letter to the company last week accusing it of falsifying data and manipulating samples over a five-year period at its Houston bioanalytics lab.

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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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FDA inspections find Cetero faked records, manipulated samples

Wednesday, July 27, 2011 01:43 PM

Drug companies that had medicines tested by contractor Cetero Research might have to re-evaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples, according to Reuters.

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Insufficient advisory board members due to conflict-of-interest rules

Wednesday, July 27, 2011 01:19 PM

Conflict-of-interest rules restricting scientists with financial ties to drug and device- makers from advising U.S. regulators may loosen next year, said FDA Commissioner Margaret Hamburg, according to Bloomberg News.

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FDA, EMA reviewing Sanofi’s Multaq

Monday, July 25, 2011 01:54 PM

U.S. drug regulators are reviewing data from a halted clinical trial of Sanofi's key heart drug Multaq to determine how it may affect patients taking it for approved indications, according to Reuters.

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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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Editors: FDA medical-device approval studies flawed

Friday, July 22, 2011 10:10 AM

Studies concluding U.S. reviews of medical devices lag behind those in Europe and drive up costs for makers are flawed, according to editors of three medical journals, Bloomberg News reported.

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Venture capital funding for biotech soars 46%

Wednesday, July 20, 2011 01:52 PM

Venture capital funding in biotechnology companies jumped 46% in the second quarter, as investors looked to replenish their portfolios after an increase in acquisitions and initial public offerings, according to Bloomberg News.

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