Theravance Inc. (THRX) announced that it has received from the U.S. Food and Drug Administration a letter indicating that Theravance's response to the November 2009 Complete Response letter for the telavancin New Drug Application or NDA for the treatment of nosocomial pneumonia or NP is incomplete and that the review clock will not start until the FDA receives a complete response.
Telavancin is a bactericidal, once-daily injectable investigational antibiotic for the treatment of NP caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
VIBATIV (telavancin) is approved in the United States and in Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group.
The letter also suggested that the study population should contain patients with a high likelihood of having the disease of interest. Therefore, the inclusion criteria for enrolled patients should include evidence of a new or progressive infiltrate on chest radiograph with at least two of the following features: fever > 38 degrees C, leukocytosis or leukopenia, and purulent lower respiratory tract secretions. Chest radiograph interpretation should be performed by a blinded healthcare provider, preferably a radiologist or pulmonologist, not directly involved in assessment of the patient for enrollment or during subsequent care.
The letter also suggested that Uniform criteria should be applied to identify the quality of sputum and endotracheal aspirate specimens for culture and subsequent pathogen identification. The use of adjunctive antibacterial therapy should be minimized and rapid de-escalation criteria should be included in the study protocol.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.