PHARMACY

FDA says failure to submit DTC ads will rate higher user fees

BY Drew Buono

WASHINGTON The Food and Drug Administration is asking companies to notify them if they plan on participating in the agency’ direct-to-consumer advertisement review program in fiscal 2008, or suffer higher user fees.

The information from the companies will be used to establish the fiscal 2008 user fee amount charges for each submission. The companies will pay two fees under the program: one for each advertisement submitted and one paid during the company’s first year of participation in the program to establish a reserve fund.

The fee levels will be set to generate revenues of $6.25 million in the first year and at least $11.25 million from both user fee programs combined. This money will be used to hire 27 staff member to review submissions in 2008.

The FDA is looking to receive the money within 120 days after the bill’s enactment, or otherwise the program will not start. Companies will not have to pay fees for advertisements required for FDA review before dissemination, such as those for accelerated approval drugs.

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PHARMACY

GSK ready to cut jobs following quarterly losses

BY Drew Buono

PHILADELPHIA GlaxoSmithKline is ready to let some of its workers go to make up for its recent report of lost earnings.

The company reported that total pharmaceutical turnover for the third quarter fell by 2% to $9.4 billion. In the United States, turnover fell 7% to $4.5 billion, impacted by continued generic competition and largely because of a 38 percent drop in sales of its diabetes drug Avandia.

The plan is a three-year $1.4 billion move that includes job cuts, most likely starting at its Avandia sales force. According to the London Times, the company is awaiting what the Food and Drug Administration will report about their findings on Avandia and if it should receive a “black box” warning for heart attack risks.

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FDA approves Marillion NDA for novel cancer treatment

BY Drew Buono

MALVERN, Pa. Marillion Pharmaceuticals has received approval from the Food and Drug Administration for it investigational new drug application for its lead product candidate MN-201, a vitamin D5 analog for the treatment of cancer.

The drug will now proceed to Phase 1 human clinical trial for patients with advanced tumors in various cancers.

In preclinical studies, MN-201 performed well against cancer cells. In animal models, MN-201 also resulted in anti-tumor activity including tumor regression in xenograft models of major solid tumor types. In contrast to treatment with other vitamin D(3) analogs and the naturally occurring vitamin D hormone, calcitriol, favorable anticancer effects with MN-201 were observed in the absence of significantly raised calcium levels.

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