Theravance’s Vibativ To Get FDA Panel Review For Hospital-Acquired Pneumonia
This article was originally published in The Pink Sheet Daily
Theravance has received two complete response letters but says it does not plan to do additional clinical studies for the new indication; Vibativ production has been halted in the U.S. and its marketing authorization withdrawn in Europe.
You may also be interested in...
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.
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.
DOTW looks at Astellas’ oncology ambitions plus its recent split with partner Ambit, as well as analysis of Shire’s buyout of Premacure, AbbVie’s out-license of an anti-interleukin-13 antibody to Receptos and the Merck/Luminex collaboration on a companion diagnostic for Alzheimer’s disease.