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Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Aradigm Corporation today announced that it dosed the first patient in the U.S. as part of its ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial, an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE) under a U.S. IND. This orphan disease indication is a chronic, severe respiratory disease and there are currently no approved treatments for this disease in the U.S.

23 Feb 2010

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., has received notice of allowance from the US Patent Office for its two key patent applications covering methods of use and compositions covering the use of betahistine with olanzapine for the mitigation of the serious weight gain associated as a side effect of the antipsychotic drug.

23 Feb 2010

Newborn Possibilities program for babies at-risk for neurological injury

For every 1,000 children born in the U.S. today, two to three are at risk for developing cerebral palsy because of injuries to the brain that may have occurred prior to or during birth. There is currently no cure for cerebral palsy, but Newborn Possibilities is a first-of-its-kind program recently launched in Tucson, which may offer new options for newborns at-risk for neurological injury.

23 Feb 2010

Viamet Pharmaceuticals, Novartis Option Fund partner to develop novel inhibitors against key metalloenzyme target

Viamet Pharmaceuticals, Inc. announced today that it has entered into a licensing option agreement with the Novartis Option Fund. Under terms of the agreement, Viamet will utilize its proprietary Metallophile™ Technology to discover and develop novel metalloenzyme inhibitors against a specific metalloenzyme of high interest to Novartis. The agreement includes an upfront fee and potential milestones totaling over $200 million as well as product royalties.

23 Feb 2010

Merrimack Pharmaceuticals commences dosing in MM-121/Tarceva combination Phase 1/2 study for NSCLC

Merrimack Pharmaceuticals, Inc. announced today that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with non-small cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121.

23 Feb 2010

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

23 Feb 2010

AAN guideline evaluates drugs’ safety and efficacy for treatment of muscle cramps

A new guideline from the American Academy of Neurology recommends that the drug quinine, although effective, should be avoided for treatment of routine muscle cramps due to uncommon but serious side effects.

23 Feb 2010

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

BioSante Pharmaceuticals, Inc., today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

22 Feb 2010

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. RSV infection in lung transplant patients represents an important unmet medical need; the condition is associated with significant morbidity, including the development of acute lung transplant rejection in 10% to 20% of infected patients.

22 Feb 2010

Highest assault rates associated with carry-out sites selling alcohol for off-premise consumption

More alcohol sales sites in a neighborhood equates to more violence, and the highest assault rates are associated with carry-out sites selling alcohol for off-premise consumption, according to new research released today (Feb. 21) by two Indiana University professors.

22 Feb 2010

Aeolus Pharmaceuticals' first fiscal quarter net loss rises

Aeolus Pharmaceuticals, Inc. announced today financial results for the three months ended December 31, 2009. The Company reported a net loss of $15,276,000, or $0.33 per basic share, compared to a loss of $459,000, or $0.01 per basic share, for the three months ended December 31, 2008.

19 Feb 2010

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

BioCrossroads' Indiana Seed Fund has invested in Bioscience Vaccines, Inc. to accelerate the development of biologic materials, which may boost the effectiveness of a wide range of life-saving vaccines.

19 Feb 2010

Neovasc completes final tranche of previously announced non-brokered private placement

Neovasc Inc. today announced that it has completed the final tranche of a previously announced non-brokered private placement. The aggregate gross proceeds of the financing totaled $1.537 million through placement of approximately 5.692 million units at a price of $0.27 per unit, comprised of a first tranche of $1.329 million announced January 28, 2010 and this second tranche of $208,000.

19 Feb 2010

United Therapeutics announces withdrawal of Tyvaso European MAA for treatment of PAH

United Therapeutics Corporation announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.

19 Feb 2010

BioTrends' Stelara second wave report finds increase in prescribing among dermatologists

BioTrends published the second wave of LaunchTrends®: Stelara, highlighting dermatology market trends at three months post launch. The report is based on 76 survey responses and 20 qualitative phone interviews with U.S. dermatologists.

19 Feb 2010

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that delays in the U.S. approval and launch of Theravance/Astellas's Vibativ (telavancin) for the treatment of nosocomial pneumonia will reduce by more than half the commercial impact that it was previously forecasted to garner in the methicillin-resistant Staphylococcus aureus (MRSA) drug market.

19 Feb 2010

PsychoGenics announces alliance with experimental neuropharmacology expert for specialized microdialysis services

PsychoGenics Inc. today announced the establishment of an exclusive alliance with Dr. Jan Kehr, an internationally recognized expert in experimental neuropharmacology, to provide specialized microdialysis services to complement PsychoGenics’ in vivo testing capabilities.

19 Feb 2010

AGH neurosurgeons explore new therapeutic approach for brain tumor

Neurosurgeons at Allegheny General Hospital (AGH) are exploring use of a drug that illuminates brain tumor cells to determine if the experimental visualization technique will enhance their ability to surgically excise tumors and improve patient survival.

19 Feb 2010

UBC researcher finds improved uptake of highly active antiretroviral therapy

A comprehensive population-based study, conducted by the BC Centre for Excellence in HIV/AIDS (BC-CfE) and presented at the 17th Conference on Retroviruses and Opportunistic Infections in San Francisco, shows that expanded highly active antiretroviral therapy (HAART) coverage was associated with a 50% decrease in new yearly HIV infections among injection drug users.

19 Feb 2010

Efficacy News and Research

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Newborn Possibilities program for babies at-risk for neurological injury

Viamet Pharmaceuticals, Novartis Option Fund partner to develop novel inhibitors against key metalloenzyme target

Merrimack Pharmaceuticals commences dosing in MM-121/Tarceva combination Phase 1/2 study for NSCLC

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

AAN guideline evaluates drugs’ safety and efficacy for treatment of muscle cramps

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Highest assault rates associated with carry-out sites selling alcohol for off-premise consumption

Aeolus Pharmaceuticals' first fiscal quarter net loss rises

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

Neovasc completes final tranche of previously announced non-brokered private placement

United Therapeutics announces withdrawal of Tyvaso European MAA for treatment of PAH

BioTrends' Stelara second wave report finds increase in prescribing among dermatologists

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

PsychoGenics announces alliance with experimental neuropharmacology expert for specialized microdialysis services

AGH neurosurgeons explore new therapeutic approach for brain tumor

UBC researcher finds improved uptake of highly active antiretroviral therapy

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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