atrial fibrillation news from FierceBiotech

An FDA expert panel has unanimously turned thumbs down on Solvay's tedisamil for atrial fibrillation. The experts said they would need more and better data before they could change their decision.... Read more...

Several big developers will take the stage at the American Society of Hematology meeting to provide updates on a string of new blood thinners that are in the clinic. Read more...

Sagent Pharmaceuticals has lined up $53 million in venture financing, a big first round for the start-up based in Schaumburg, IL. Vivo Ventures led the round for Sagent, which was launched in 2006.... Read more...

> Pfizer is transferring its German HQ from Berlin to Karlsruhe. Report

> The UK's NICE has reversed itself, calling for the use of Eli Lilly's Alimta in fighting asbestos-related cancer. Report

> The FDA has approved Barr's copycat version of Dostinex. …

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Canada's Cadiome announced that the lower of two doses in a Phase IIa trial of RSD1235 for atrial fibrillation hit its primary endpoint and that the drug demonstrated a good safety profile. A higher dose of the drug "trended" positive but did not achieve a statistically significant improvement in volunteers. Eight percent of patients taking a placebo reported a serious adverse event compared to 10 percent taking the lower dose of the drug and 11 percent taking 600 mg doses.

"This …

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Sanofi-Aventis says that the FDA has rejected its heart drug Multaq (dronedarone), evidently unsatisfied with the data provided to support its application. Multaq is designed to treat atrial fibrillation. Sanofi-Aventis hasn't given up on the drug, though. The company says it plans to refile for approval in the first half of 2008, after it receives a fresh batch of data from an ongoing study. Last February the FDA rejected Sanofi-Aventis' bid to market Acomplia. And analysts weren't happy …

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Cardiome and Astellas have revised their development pact on RSD 1235, an experimental therapy for atrial fibrillation, the most common form of arrhythmia. The FDA had rejected their application for the drug last spring, citing inconsistencies and omissions in the data they provided. Developers blamed a clerical error. In the new agreement, Astellas will pay Cardiome $10 million when it files with the agency and will cover all the costs of revising the application. In their original …

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> Salix Pharmaceuticals is hoping it can delay a generic competitor to its most lucrative pharmaceutical. Report

> ViroPharma has added a fresh set of complaints to the objections being raised against a generic competitor to its antibiotic Vancocin. The drug developer says that the agency should require clinical studies to establish bioequivalence. Allowing laboratory work alone …

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> Canada's Response Biomedical has raised $12 million in financing for its diagnostic testing business and added five former officers and directors of ID Biomedical to its board of directors. Release

> The FDA has issued an approvable letter for Prestwick Pharmaceuticals' Xenazine as a treatment for chorea associated with Huntington's disease. …

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CryoCor has decided to lay off 20 of 58 employees as it focuses on gaining approval for a new therapy for irregular heartbeat. Earlier this month the FDA told CryoCor that its trial data did not support an approval for the treatment, which involves freezing tissue that physicians believe causes atrial fibrillation. The therapy was approved in Europe in 2002 and CryoCor executives appear hopeful that more data may change the FDA's mind.

- read this article from the San Diego Union-Tribune