Targanta Therapeutics announces posting of briefing documents for review of FDA
Suffering from end-stage renal disease (ESRD), a growing number of patients at the Centre hospitalier de l’Université de Montréal (CHUM), have become the beneficiaries of a North American breakthrough: high efficacy hemodiafiltration (HDF). An extracorporeal blood purification technique, HDF is indicated for ESRD patients. Since the HDF unit was introduced in CHUM’s Nephrology section, preliminary
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Targanta Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the November 19, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting.
AIDAC will review Targanta’s New Drug Application (NDA) for oritavancin for the treatment of complicated skin and skin structure infection (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus , or MRSA.
Briefing documents from FDA and Targanta can be found on FDA’s website at http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4394b2-00-Index-FDA.htm.
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria, including methicillin-resistant Staphylococcus aureus , or MRSA. These types of resistant infections have created a market that IMS Health estimated to be over one billion dollars in the U.S. in 2007 and growing rapidly. In its intravenous (IV) formulation, the product candidate has been tested in over 1,900 individuals and has completed two Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met. The NDA dossier includes data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, including a broad range of gram-positive strains resistant to commonly used antibiotics such as oxacillin, methicillin, vancomycin, daptomycin, and linezolid. FDA’s action date for the oritavancin NDA is December 8, 2008.
Swissmedic, the Swiss agency for therapeutic products, has approved Zevtera (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections, including diabetic foot infections which have not spread to the bone. Ceftobiprole is licensed from and co-developed with Basilea Pharmaceutica Ltd. Janssen-Cilag will market ceftobiprole in Switzerland under the trade name Zevtera.
Full Post: Swiss approval for Zevtera in treatment of complicated skin and soft tissue infections
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve
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Rates of antibiotic-resistant head and neck infections increased in pediatric patients nationwide between 2001 and 2006, according to a report in the January issue of Archives of Otolaryngology-Head & Neck Surgery. Before the 1980s, infections with strains of the bacteria Staphylococcus aureus resistant to the antibiotic methicillin (methicillin-resistant Staphylococcus aureus, or MRSA) were most often
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Pre-operative screening of patients for methicillin-resistant Staphylococcus aureus (MRSA) may be an effective way to reduce infection rates following otolaryngic surgeries, according to new research published in the January 2009 issue of Otolaryngology - Head and Neck Surgery. The study, conducted by researchers at the Massachusetts Ear & Eye Infirmary, is the first to review otolaryngic
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An enzyme that lives in Methicillin-resistant Staphylococcus aureus (MRSA) and helps the dangerous bacterium to grow and spread infection through the human body has been visualised for the first time, according to a study out today in Proceedings of the National Academy of Sciences (PNAS). Now, armed with detailed information about the structure of
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