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Intercell's IC43 Phase II trial against Pseudomonas aeruginosa infections meets primary endpoint

Intercell AG today announced results from a Phase II clinical trial involving the company's investigational nosocomial vaccine candidate (IC43) against infections with the bacterium Pseudomonas aeruginosa, a leading cause of hospital-acquired infections with increasing antibiotic resistance and hence a very high unmet medical need.

25 Oct 2010

Chimerix to present CMX001 data for viral infections at IDSA Annual Meeting

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, will present promising clinical data for CMX001 in a late-breaker poster session at the Infectious Diseases Society of America (IDSA) 48th Annual Meeting.

25 Oct 2010

Novartis informs Emisphere on First Interpretable Results of two-year Phase III Study 2301 in osteoarthritis

Emisphere Technologies, Inc. announced today that Novartis Pharma AG provided Emisphere with information regarding the First Interpretable Results of the two-year Phase III Study 2301 in osteoarthritis conducted by its license partner Nordic Bioscience with oral calcitonin (SMC021).

25 Oct 2010

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Optimer Pharmaceuticals, Inc. announced today the presentation of combined data from its two fidaxomicin Phase 3 trials in patients with Clostridium difficile infection (CDI) at the 48th Annual Meeting of the Infectious Disease Society of America (IDSA) in Vancouver, British Columbia, Canada.

25 Oct 2010

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Pharmaceutical company Pharmaxis today announced significant results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis.

25 Oct 2010

Revance presents results of RT001 two Phase 2b clinical trials for lateral canthal lines at Chicago annual meeting

Revance Therapeutics, Inc. today announced that the results of two Phase 2b clinical trials on RT001, a topical botulinum toxin type A which is under investigation for the treatment of lateral canthal lines (crow's feet wrinkles) were presented at the annual meeting of the American Society of Dermatologic Surgery in Chicago.

25 Oct 2010

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.

22 Oct 2010

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Inspire Pharmaceuticals, Inc. announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the 24th Annual North American Cystic Fibrosis Conference (NACFC) October 21-23, 2010 in Baltimore, Maryland.

22 Oct 2010

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

Talecris Biotherapeutics today announced the publication of results from a study showing that PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human]) (A1PI) is as effective as PROLASTIN (Alpha1-Proteinase Inhibitor [Human]) in raising levels of alpha-1 protein in patients with alpha1-antitrypsin (AAT) deficiency.

22 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

AiCuris’ AIC246 inhibitor treats patient with multi-organ HCMV disease

AiCuris announced today that its novel HCMV inhibitor AIC246 has been used successfully to treat a patient with multi-organ HCMV disease caused by multi-resistant virus. Details will be presented at the 48th IDSA meeting on October 23, presentation number LB-38.

22 Oct 2010

Myrexis to present Phase 2 monotherapy study results of Azixa in patients with GBM

Myrexis, Inc., a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced it will present at the 2010 Society for Neuro-Oncology Scientific Meeting and Education Day, to be held November 18-21, 2010 in Montreal, Canada.

22 Oct 2010

Novartis releases study results on oral calcitonin for treatment of osteoarthritis: Unigene Laboratories

Unigene Laboratories, Inc. announced today that Novartis has released information on the first of two studies on oral calcitonin for the treatment of osteoarthritis conducted by its license partner Nordic Bioscience. The recently completed Study 2301, which assesses the safety and efficacy of oral calcitonin in the treatment of knee osteoarthritis, had three co-primary endpoints.

22 Oct 2010

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Idera Pharmaceuticals, Inc. today announced results from its single-dose, dose-escalation Phase 1 clinical trial evaluating the safety and mechanism of action of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for the treatment of autoimmune and inflammatory diseases.

22 Oct 2010

Advaxis completes patient recruitment in ADXS11-001 phase II study for cervical dysplasia

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, completes recruitment of the first group of patients in its US cervical dysplasia (CIN) phase II study of ADXS11-001 as required for the planned DMSB (safety board) meeting scheduled to be held January 11, 2011.

22 Oct 2010

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

21 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

BioCryst to present intravenous peramivir data for influenza treatment at IDSA meeting

BioCryst Pharmaceuticals, Inc. announced the presentation of data related to intravenous (i.v.) peramivir for the treatment of influenza at the 48th Annual Infectious Diseases Society of America (IDSA) meeting being held in Vancouver, Canada.

21 Oct 2010

Drug Trial News

Intercell's IC43 Phase II trial against Pseudomonas aeruginosa infections meets primary endpoint

Chimerix to present CMX001 data for viral infections at IDSA Annual Meeting

Novartis informs Emisphere on First Interpretable Results of two-year Phase III Study 2301 in osteoarthritis

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Revance presents results of RT001 two Phase 2b clinical trials for lateral canthal lines at Chicago annual meeting

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Inspire presents data on denufosol therapy for cystic fibrosis at NACFC conference

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

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

AiCuris’ AIC246 inhibitor treats patient with multi-organ HCMV disease

Myrexis to present Phase 2 monotherapy study results of Azixa in patients with GBM

Novartis releases study results on oral calcitonin for treatment of osteoarthritis: Unigene Laboratories

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Advaxis completes patient recruitment in ADXS11-001 phase II study for cervical dysplasia

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

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

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

BioCryst to present intravenous peramivir data for influenza treatment at IDSA meeting

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