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Severe combined immunodeficiency treated successfully with gene therapy

Gene therapy can offer a cure for a rare condition that causes children’s immune systems to fail. In this rare condition, known as Severe Combined Immunodeficiency (SCID), inherited genetic mutations mean that babies are unable to fight off infection, severely limiting their chances of surviving more than a few years. Severe combined immunodeficiency (SCID) is a rare genetic disorder estimated to affect between 1 in 200,000 and 1 in 1,000,000 live births

26 Aug 2011

Firazyr receives FDA approval for treatment of HAE acute attacks

The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.

26 Aug 2011

Boehringer Ingelheim, Lilly receive EU approval for linagliptin to treat type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today received Marketing Authorization from the European Commission for linagliptin 5 mg film-coated tablets for the treatment of adults with type 2 diabetes.

26 Aug 2011

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

26 Aug 2011

CVRx introduces CE Mark approved Barostim neo for treatment of uncontrolled hypertension

CVRx, Inc., a private medical device company, introduced today its second-generation implantable device, the Barostim neo, for the treatment of uncontrolled hypertension. The Barostim neo features a new unilateral, 1mm electrode and a new smaller, more advanced stimulator to allow for more focused and efficient delivery of therapy. These improvements have led to shorter procedure times and extended longevity.

25 Aug 2011

Achievement of physical activity goals linked to reduced arthritis pain, increased quality of life

Researchers from The Netherlands report that patients with rheumatoid arthritis (RA) who have higher levels of self-efficacy for physical activity are more likely to achieve their physical activity goals.

25 Aug 2011

AMT total net loss decreases 7% to € 8.7 million for first half year of 2011

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today reported its results for the first half year of 2011.

25 Aug 2011

Neovasc second quarter revenues decrease 8% to $879,405

Neovasc Inc., today announced financial results for the three and six months ended June 30, 2011.

24 Aug 2011

FDA grants fast track designation for Pharmasset's PSI-938 to treat chronic HCV infection

Pharmasset, Inc. has received fast track designation from the U.S. Food and Drug Administration (FDA) for PSI-938 for the treatment of chronic hepatitis C virus (HCV) infection.

24 Aug 2011

United Therapeutics completes treprostinil diethanolamine Phase 3 trial in PAH

United Therapeutics Corporation announced today the completion of its FREEDOM-C(2) Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension.

24 Aug 2011

Cardiac rehabilitation, telephone counseling support exercise maintenance

Researchers from The Miriam Hospital have found that patients who have completed cardiac rehabilitation and who receive telephone counseling that supports exercise are more likely to adhere to an exercise program. Results of the study, funded by the National Heart, Lung and Blood Institute, are published in the American Journal of Preventive Medicine.

24 Aug 2011

Health Canada accepts Sunovion Pharmaceuticals Canada's lurasidone NDS for review

Sunovion Pharmaceuticals Canada Inc., formerly Sepracor Pharmaceuticals, Inc., today announced that the New Drug Submission (NDS) for Lurasidone HCl, for the treatment of adult patients with schizophrenia has been accepted for review by Health Canada. The NDS was submitted to Health Canada in June 2011 and will receive a standard review.

24 Aug 2011

Simvastatin may reduce spinal cord damage from ischemia/reperfusion injury

The cholesterol-lowering drug simvastatin appears to reduce spinal cord injury caused by oxygen deprivation in experimental animals, according to a study in the September issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

24 Aug 2011

Celldex announces key in vivo efficacy results of CDX-1135 in Dense Deposit Disease

Celldex Therapeutics, Inc. today announced key in vivo efficacy data for its CDX-1135 program from a collaboration with Drs. Richard Smith and Carla Nester at the University of Iowa.

24 Aug 2011

Trophos awarded US patent covering use of novel cardioprotective compound

Trophos SA a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced today that the United States Patent and Trademark Office (USPTO) has granted a patent for the use of their novel mitochondrial pore modulator, TRO40303, for cytoprotection. The patent provides coverage for the use of Trophos’ TRO40303 to reduce the cardiac reperfusion injury that contributes significantly to the morbidity and mortality seen after a heart attack (myocardial infarction - MI).

23 Aug 2011

BioLineRx second quarter net loss decreases to NIS 16.4 million

BioLineRx Ltd., a biopharmaceutical development company, today reported its results for the second quarter ending June 30, 2011.

23 Aug 2011

Helsinn begins enrollment in anamorelin Phase III trial for NSCLC-associated anorexia/cachexia

Helsinn, a Swiss-based pharmaceutical company, announced today that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer.

23 Aug 2011

Spinifex secures AU$6.25 million in expanded Series B funding

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured a further AU$6.25 million of venture capital investment from GBS Venture Partners Limited, Brandon Capital Partners Pty Limited, Uniseed Management Pty Limited and UniQuest Pty Limited to fund the development of its pain management drug, EMA401.

23 Aug 2011

OICR President announces $12.6M in funding for High Impact Clinical Trials Program

Dr. Tom Hudson, President and Scientific Director of the Ontario Institute for Cancer Research (OICR), today announced $12.6 million in funding over four years for OICR's High Impact Clinical Trials (HICT) Program.

23 Aug 2011

Symphogen initiates Sym004 Phase 2 trial in squamous cell carcinoma of head and neck cancer

Symphogen A/S today announced the initiation of a Phase 2 clinical trial to investigate the safety and efficacy of Sym004 in patients who have failed anti-EGFR monoclonal antibody (mAb)-based therapy, with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

23 Aug 2011

Efficacy News and Research

Severe combined immunodeficiency treated successfully with gene therapy

Firazyr receives FDA approval for treatment of HAE acute attacks

Boehringer Ingelheim, Lilly receive EU approval for linagliptin to treat type 2 diabetes

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

CVRx introduces CE Mark approved Barostim neo for treatment of uncontrolled hypertension

Achievement of physical activity goals linked to reduced arthritis pain, increased quality of life

AMT total net loss decreases 7% to € 8.7 million for first half year of 2011

Neovasc second quarter revenues decrease 8% to $879,405

FDA grants fast track designation for Pharmasset's PSI-938 to treat chronic HCV infection

United Therapeutics completes treprostinil diethanolamine Phase 3 trial in PAH

Cardiac rehabilitation, telephone counseling support exercise maintenance

Health Canada accepts Sunovion Pharmaceuticals Canada's lurasidone NDS for review

Simvastatin may reduce spinal cord damage from ischemia/reperfusion injury

Celldex announces key in vivo efficacy results of CDX-1135 in Dense Deposit Disease

Trophos awarded US patent covering use of novel cardioprotective compound

BioLineRx second quarter net loss decreases to NIS 16.4 million

Helsinn begins enrollment in anamorelin Phase III trial for NSCLC-associated anorexia/cachexia

Spinifex secures AU$6.25 million in expanded Series B funding

OICR President announces $12.6M in funding for High Impact Clinical Trials Program

Symphogen initiates Sym004 Phase 2 trial in squamous cell carcinoma of head and neck cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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