FDA

FDA approves first gene-targeted drug for Melanoma

Wednesday, August 17, 2011 12:05 PM

The FDA has approved Zelboraf, known as vemurafenib or PLX4032 during testing, well ahead of the approval deadline.  Zelboraf is the first drug to treat advanced melanoma by targeting a specific gene mutation.

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Marshall Edwards’ lead candidate ME-143 receives FDA approval

Tuesday, August 16, 2011 10:16 AM

Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has reported that its Investigational New Drug (IND) application for ME-143 (formerly NV-143),  the company's lead NADH oxidase inhibitor, has been approved by the FDA. The company plans to initiate a phase I clinical trial of intravenous ME-143.

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FDA issues guidance to improve clinical study quality

Monday, August 15, 2011 01:40 PM

The FDA has issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

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CTTI report recommends risk-based monitoring

Monday, August 15, 2011 08:02 AM

Almost 90% of those conducting clinical trials within the commercial drug industry always perform on-site visits to their study sites. In contrast, about a third of academic, government or cooperative groups involved in research do. And yet, neither monitoring method is based on any evidence that it improves the quality of the data, as no such evidence yet exists.

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FDA reviews BYDUREON, type 2 diabetes medication

Friday, August 12, 2011 02:48 PM

Amylin Pharmaceuticals, Eli Lilly, and Alkermes have reported that the FDA has acknowledged the companies’ BYDUREON (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.

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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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