November 2006

The FDA On Madison Avenue

Wednesday, November 29, 2006

The Food and Drug Administration (FDA) has a deal in place that for the first time would allow pharma companies to pay fees for the FDA to review their drug advertisements. It is all being done in the hope of faster reviews. It’s not such a bad idea.

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eClinical Market Has Strong Year

Monday, November 27, 2006

In its third quarter, Morrisville, N.C.-based eClinical service provider etrials reported 40% growth in services revenue to $4.4 million.Net revenues during the same period in 2005 were $3.2 million. The company reported operating income of $178,331 compared with an operating loss of $148,618 in 2005 during the same period. etrials went public in 2005 in a reverse merger.

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FDA Proposes New Regulations for Expanded Access to Investigative Drugs

Tuesday, November 21, 2006

The U.S. Food and Drug Administration (FDA) has submitted two regulatory proposals that would expand the rules concerning who has access to investigative treatments. The new proposals would provide a clearer pathway for certain critically ill patients so they can be considered for access to investigative drugs without enrolling in a clinical trial.Both proposals have been submitted to the Office of Management and Budget (OMB), where they will be reviewed for approval.

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Novartis Makes Big Play in China

Wednesday, November 15, 2006

Following in AstraZeneca’s footsteps, Novartis is investing $100 million in an R&D center in China. It’s a move I had alluded to in an earlier piece in this forum. Expect other big pharma companies to follow.

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Don’t Be Outfoxed By Dems’ Win

Tuesday, November 14, 2006

The Democrats’ decisive victory in Tuesday’s mid-term election put them in control of the House, but it is widely seen as bad news for the pharmaceutical industry. Dire predictions of drug price controls have many in big pharma concerned. Pharma should be worried—especially if it sticks to the old game plan.

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Can EU Regulators Keep Up with Innovation?

Wednesday, November 8, 2006

The now infamous TeGenero clinical trial – six patients fell critically ill from an investigational biologic — occurred, ironically, after the EU Clinical Trials Directive had been implemented in the UK in May 2004. Biotechs in the Netherlands, it seems, were adjusting to the adoption of the EU Clinical Trials Directive into national law on March 1, 2006 when the TeGenero incident occurred (March 13). Before that, healthy volunteer trials in the UK had been unregulated.

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