Antibiotic News and Research

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Antibiotics are drugs used to treat infections caused by bacteria and other microorganisms.

FDA issues complete response letter for ViroPharma's Cinryze

ViroPharma Incorporated today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

25 Oct 2010

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

A new analysis of data from more than 12,000 people with cystic fibrosis (CF) and Pseudomonas aeruginosa (Pa) lung infection in the Cystic Fibrosis Foundation's Patient Registry shows that use of TOBI (Tobramycin Inhalation Solution, USP) was associated with a 21% reduction in mortality in the following year.

22 Oct 2010

Hospira announces launch of piperacillin and tazobactam injection in the US

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the launch of piperacillin and tazobactam for injection in the United States. The medication is a generic version of Zosyn, the world's leading injectable antibiotic, from Pfizer. Piperacillin and tazobactam injection posted 2009 U.S. sales of more than $855 million.

22 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).

21 Oct 2010

Scientists suggest enzyme that modifies 4-quinolones can reduce microbial infection

So disease-causing bacteria in the body finally have multiplied to the point where their numbers are large enough to cause illness. What's next? They get out their "smart phones" and whisper "Let's roll!" That's how an article in ACS' monthly Chemical Reviews describes the substances "smart phones of the microbial world" that bacteria use to transmit chemical signals that launch infections and monitor their environment.

21 Oct 2010

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Aradigm Corporation today announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.

20 Oct 2010

UTHSC-Houston initiates enrollment in NanoLogix technology trial for detection of GBS in pregnant women

NanoLogix, an innovator in the accelerated detection and identification of microorganisms, announced today that the University of Texas Health Science Center in Houston is enrolling 300 patients in an ongoing clinical trial to study the speed and accuracy of NanoLogix technology. The trial is designed to compare NanoLogix technology to current methods in use for detection and identification of Group B Streptococcus (GBS) in pregnant women.

20 Oct 2010

Cubist announces pricing of 2.50% Convertible Senior Notes due 2017

Cubist Pharmaceuticals, Inc. today announced the successful pricing of $400 million aggregate principal amount of its 2.50% Convertible Senior Notes due 2017. Cubist has granted the underwriters an option to purchase up to an additional $50 million aggregate principal amount of the notes.

20 Oct 2010

CIED implantation with AIGISRx Antibacterial Envelope reduces overall infection rate

Patients undergoing CIED (Cardiac Implantable Electronic Device) implantation with TYRX, Inc.'s FDA-cleared AIGISRx Antibacterial Envelope enjoyed a 99.5% rate of successful implantation with an overall infection rate of 0.48% in the first 1.9 months following the procedure, as reported in newly published results of TYRX's COMMAND Clinical Study.

20 Oct 2010

Research calls for better environmental risk assessments of pharmaceuticals

The strategies used to assess the environmental risks posed by pharmaceuticals are not enough to protect natural microbial communities, reveals a researcher from the University of Gothenburg (Sweden) who is calling for better environmental risk assessments.

19 Oct 2010

ACG 75th Scientific Meeting to review advances in gastrointestinal research, treatment of digestive diseases

Many of the world's preeminent gastroenterologists will gather for the American College of Gastroenterology's (ACG) 75th Annual Scientific Meeting at the Henry B. Gonzalez Convention Center in San Antonio, Texas starting Monday October 18, 2010, to review the latest scientific advances in gastrointestinal research, treatment of digestive diseases and clinical practice management.

19 Oct 2010

Researchers explore impact of various factors on increasing rates of Clostridium difficile infection

In five different studies presented at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, researchers explored the impact of various factors on increasing rates of Clostridium difficile infection (C. difficile), such as the use of proton pump inhibitors (PPIs) and the substantial increase in antibiotic use due to new National Hospital Quality Measures; strategies to combat high rates of C. difficile infections; and cutting‐edge treatments for this potentially deadly-and quite common-infection.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

Study finds IAP enzyme maintains normal microbial population in gastrointestinal system

An enzyme that keeps intestinal bacteria out of the bloodstream may also play an important role in maintaining the normal microbial population of the gastrointestinal system.

19 Oct 2010

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) of Munich to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.

18 Oct 2010

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

NovaBay Pharmaceuticals, Inc. announced today that its development partner, Alcon Research, Ltd., has concluded its proof of concept clinical trial of NovaBay's patented lead Aganocide compound, NVC-422 for the treatment of viral conjunctivitis a highly contagious eye infection for which there are currently no marketed products.

18 Oct 2010

Cempra to present data on solithromycin, TAKSTA at 48th Annual Meeting in Vancouver

Cempra Pharmaceuticals today announced poster presentations on its novel fluoroketolide antibiotic, solithromycin (CEM-101), and the Company's proprietary front-loading oral dosing regimen of sodium fusidate, TAKSTA (CEM-102) at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.

18 Oct 2010

Whooping cough cases increase

Whooping cough (Pertussis) a dreaded childhood disease that is vaccine preventable is back. After two doctors in Adelaide tested positive to whooping cough, nearly a 100 adults and children are being given precautionary antibiotics.

18 Oct 2010

Antibiotic News and Research

Further Reading

FDA issues complete response letter for ViroPharma's Cinryze

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

Hospira announces launch of piperacillin and tazobactam injection in the US

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

Scientists suggest enzyme that modifies 4-quinolones can reduce microbial infection

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

UTHSC-Houston initiates enrollment in NanoLogix technology trial for detection of GBS in pregnant women

Cubist announces pricing of 2.50% Convertible Senior Notes due 2017

CIED implantation with AIGISRx Antibacterial Envelope reduces overall infection rate

Research calls for better environmental risk assessments of pharmaceuticals

ACG 75th Scientific Meeting to review advances in gastrointestinal research, treatment of digestive diseases

Researchers explore impact of various factors on increasing rates of Clostridium difficile infection

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Study finds IAP enzyme maintains normal microbial population in gastrointestinal system

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

Cempra to present data on solithromycin, TAKSTA at 48th Annual Meeting in Vancouver

Whooping cough cases increase

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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