FDA

Yaupon Therapeutics raises $14.4 million in Series D financing

Thursday, August 11, 2011 01:49 PM

Yaupon Therapeutics, a privately held pharmaceutical company, has raised $14.4 million through a Series D private placement of preferred stock. The new round includes prior investors Vivo Ventures, Palo Alto Investors and Burrill & Company, plus new investor, Aperture Venture Partners.

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Roche seeks compromise with FDA over Avastin

Monday, August 8, 2011 01:41 PM

In a bid to salvage the breast cancer indication for Avastin, Roche’s Genentech unit has pitched to the FDA what it is calling a “middle-ground proposal” that would allow the drug to retain its indication and only for use with paclitaxel. The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide, according to Pharmalot.

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Pharma industry: Still not budgeting accurately

Monday, August 8, 2011 08:00 AM

Survey shows 57% still relying on Excel spreadsheets

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FDA approves Anascorp, first specific treatment for scorpion stings

Thursday, August 4, 2011 12:52 PM

The FDA has approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.

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Essex scolded by FDA after phony clinical trial sponsor

Thursday, August 4, 2011 12:08 PM

Earlier this year, the FDA has issued an alert that some fictitious applications were submitted to several Institutional Review Boards. The agency noted that the name and address of the clinical investigator listed on a required FDA form are the same as that used in a sting operation conducted by the US Government Accountability Office two years ago, according to Pharmalot.

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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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