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Examples
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Telavancin has already faced trouble gaining FDA approval.
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"Toxicity issues have the potential to have a major impact on the commercial viability of the drug, as we see little in these data to compel a formulary committee to choose Telavancin over Cubicin," wrote Morgan Stanley analyst Steven Harr, who reiterated a "neutral" rating on Cubist shares.
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"We forecast that Cubicin's market share in cSSSI will be materially impacted by the potential approval of Telavancin as well as potential approval of Pfizer's Zeven."
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Theravance said Phase III results for Telavancin, a treatment for complicated skin and skin structure infections cSSSI met the primary study goal.
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"We anticipate that Telavancin, if approved, will be used similarly to Cubicin -- primarily after Vancomycin failures -- and will compete directly with Cubicin for market share," Sendek wrote in a note to clients.
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"Toxicity issues have the potential to have a major impact on the commercial viability of the drug, as we see little in these data to compel a formulary committee to choose Telavancin over Cubicin," it said.
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Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.
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Telavancin is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
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Telavancin was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA.
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Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.
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