Author: PharmaTimes

FDA requests more information on Entereg

Adolor’s share price took a knocking on the Nasdaq Stock Exchange after it revealed that approval of its gastrointestinal drug, Entereg, (alvimopan), could face a delay after the US Food and Drug Administration asked the company to provide more information about its use in postoperative ileus.

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Baxter sees $245M Q4 charge

Baxter International says that it will be taking a $245 million dollar charge to its fourth quarter 2004 earnings, primarily to cover costs associated with the recent suspension of a trial of its influenza vaccine, PreFluCel. Including the charge, the company expects fourth quarter earnings per share to come in at between $0.14 and $0.18.

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Pivotal trial imminent for oral MS drug

The prospect of an orally active treatment for multiple sclerosis patients has taken a step nearer with the start of Phase III trials of Mylinax (cladribine) by Ivax of the US and Switzerland’s Serono later this quarter.

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Rumours of COX-2 demise greatly exaggerated?

The future facing COX-2 inhibitors may not be as bleak as many are suggesting, according to new analysis published by Datamonitor. However, since Merck & Co’s withdrawal of Vioxx (rofecoxib) for safety reasons [[01/10/04a]], the whole class has come under the spotlight and calls to pull all COX-2 inhibitors are not surprising, says Duncan Emerson, Datamonitor’s senior healthcare analyst.

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