Theravance’s Vibativ Adds Long-Sought Pneumonia Indication
This article was originally published in The Pink Sheet Daily
Company has secured a new third-party manufacturer for the antibiotic and says it will relaunch the drug in the third quarter. FDA approval for telavancin’s use in hospital-acquired pneumonia comes four-and-a-half years after the original NDA submission for the supplemental claim.
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More companies are turning to CDER’s formal appeals process when presented with a review division’s regulatory decision or advice. Even though few appeals are granted in full, many sponsors get valuable clarity on a path forward; some appeals, like that for Amarin’s Vascepa SPA, are turned away at the door.
The biotech is bringing is long-plagued antibiotic back to U.S. patients, but is still searching for another company to help with commercialization efforts. Meanwhile, plans for its split and the launch of its partnered COPD drug are on track.
The Irish company, fighting a takeover offer from Royalty Pharma, has made the first of several planned deals: Elan will pay $1 billion to Theravance in exchange for a 21% interest in future royalty payments from four respiratory programs partnered with GlaxoSmithKline. Theravance shares soared on the news.