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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

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

New endoscopic ablation technique safe and effective for treating Barrett's esophagus

Early tumor formation in Barrett's esophagus (BE) can be effectively and safely treated with radiofrequency ablation (RFA), in combination with prior endoscopic removal of visible lesions, according to a new study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute.

19 Feb 2010

Standard checklist for home palliative sedation

Can patients near death safely receive sedation at home, fully respecting their own and their families' wishes? This practice, which is on the rise, is coming under increasing scrutiny and debate by palliative care researchers and practitioners.

19 Feb 2010

ARYx Therapeutics retains Cowen's services to optimize late-stage asset value

ARYx Therapeutics Inc., a biopharmaceutical company, today announced that it has retained Cowen and Company to explore strategic options for ARYx.

19 Feb 2010

Gladstone MD receives Potamkin Prize for identifying new avenues in Alzheimer's research

Lennart Mucke, MD, Director of the Gladstone Institute of Neurological Disease (GIND), has been named a recipient of the American Academy of Neurology's prestigious Potamkin Prize.

19 Feb 2010

Combination therapy that delays nursing home admission for AD earns 43% patient share in U.S. and 30% in Europe

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of moderate to severe Alzheimer's disease, a combination therapy that delays nursing home admission at 19 months would earn 43 percent patient share, according to surveyed U.S. neurologists. In comparison, in Europe, such an agent would earn a slightly lower patient share of 30 percent, according to surveyed European neurologists. This lower share estimate is possibly a result of higher price sensitivity of European markets.

18 Feb 2010

Efficacy News and Research

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

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

New endoscopic ablation technique safe and effective for treating Barrett's esophagus

Standard checklist for home palliative sedation

ARYx Therapeutics retains Cowen's services to optimize late-stage asset value

Gladstone MD receives Potamkin Prize for identifying new avenues in Alzheimer's research

Combination therapy that delays nursing home admission for AD earns 43% patient share in U.S. and 30% in Europe

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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