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Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the initiation of dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC). This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation.

19 Mar 2010

Lifestyle improvements and new treatments for diabetes and cardiovascular disease needed

Treatment with the anti-hypertensive drug valsartan (Diovan) led to a modest reduction in the development of type 2 diabetes but did not significantly reduce cardiovascular events in patients with impaired glucose tolerance, according to researchers at Duke University Medical Center and the University of Oxford. They jointly reported results at the American College of Cardiology meeting today from the world's first study designed to find ways to control the progression to diabetes and cardiovascular disease in people at risk.

19 Mar 2010

European CHMP issues positive opinion for Roche's Tarceva as maintenance therapy for NSCLC

Roche today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for use of Tarceva(R) (erlotinib) as a maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) and stable disease (cancer remains largely unchanged) after initial chemotherapy. The CHMP positive opinion clears the way for European Union approval and means that this group of patients may soon be able to benefit from earlier treatment with Tarceva.

19 Mar 2010

CHMP issues positive opinion recommending approval of Tarceva as monotherapy for NSCLC

OSI Pharmaceuticals, Inc. announced today that its international partner for Tarceva® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease following four cycles of standard platinum-based first-line chemotherapy.

19 Mar 2010

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

A $10.2 million commitment from the Robertson Foundation to create a state-of-the-art Translational Cell Therapy Center (TCTC) will advance Duke Medicine's pioneering cell therapy research and treatment programs for children and adults with cancer, cerebral palsy, stroke and brain injuries suffered at birth.

19 Mar 2010

Phase 1B clinical study initiated to evaluate safety and efficacy of PMX-60056

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B clinical study to evaluate the safety and efficacy of PMX-60056 in reversing the anticoagulant activity of low molecule weight heparin (LMWH).

19 Mar 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Somaxon Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.

19 Mar 2010

Risk of hereditary form of bowel cancer: New preparation of omega-3 holds hope

A new preparation of an omega-3 polyunsaturated fatty acid found naturally in fish, offers hope for thousands of patients at risk of developing an inherited form of bowel cancer, a new study shows.

18 Mar 2010

Positive preliminary results from MediciNova's Phase Ib clinical trial of MN-221 for COPD

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market and the Hercules Market of the Osaka Securities Exchange, today reported positive preliminary results from a Phase Ib clinical trial to evaluate the safety and efficacy of MN-221 in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD). There were no clinically significant safety concerns noted. Preliminary results demonstrated clinically significant improvements in percent change in forced expiratory volume in one second (FEV(1)).

18 Mar 2010

Purified form of omega 3 curbs precancerous bowel polyps

A purified form of an omega 3 cuts the number and size of precancerous bowel growths (polyps) in people whose genetic make-up predisposes them to bowel cancer, finds research published ahead of print in the journal Gut.

18 Mar 2010

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CPEX Pharmaceuticals Inc. today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents.

18 Mar 2010

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Alkermes, Inc. today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.

17 Mar 2010

Genentech submits ACTEMRA sBLA to FDA

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA).

17 Mar 2010

Booster shot appears to improve TB resistance in previously vaccinated adults

A booster shot appears to improve tuberculosis (TB) resistance in previously vaccinated adults, according to new research in South Africa.

17 Mar 2010

Acetaminophen safe and effective for reducing postpartum pain

For many mothers of newborns, lingering pain from the delivery can interfere with their first days with their infant. A recent review examined whether over-the-counter medications containing acetaminophen - Tylenol for example − provided adequate relief for such pain and concluded that they are effective.

17 Mar 2010

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Tolerx, Inc., today announced the publication in Diabetologia, the journal of the European Association for the Study of Diabetes, of the four-year follow-up clinical data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single short course of therapy with otelixizumab (ChAglyCD3).

16 Mar 2010

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Spinal Restoration, Inc. announced today that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted.

16 Mar 2010

Blocking RhoA enzyme increases survival in SMA mouse model

Scientists from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa have identified a promising new approach for developing drugs to treat Spinal muscular atrophy (SMA), the leading inherited cause of death in infants and toddlers. Dr. Rashmi Kothary and his doctoral student Melissa Bowerman have found that an enzyme called RhoA is overly active in a mouse model of the disease and blocking this enzyme can greatly increase survival. The study is published in Human Molecular Genetics.

16 Mar 2010

'Molecular band-aid' may help protect hearts of Duchenne muscular dystrophy patients

Researchers at the University of Minnesota Medical School have discovered a chemical that may, over the long term, protect the hearts of Duchenne muscular dystrophy patients - a fatal and most common form of muscular dystrophy in children.

16 Mar 2010

Genzyme, Isis Pharmaceuticals: Phase 3 study of mipomersen in hoFH patients meets primary endpoint

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced that data from a phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were published in The Lancet. This study met its primary endpoint, resulting in an average LDL-C reduction of greater than 100 mg/dL in this very high-risk patient population.

16 Mar 2010

Placebo News and Research

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

Lifestyle improvements and new treatments for diabetes and cardiovascular disease needed

European CHMP issues positive opinion for Roche's Tarceva as maintenance therapy for NSCLC

CHMP issues positive opinion recommending approval of Tarceva as monotherapy for NSCLC

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

Phase 1B clinical study initiated to evaluate safety and efficacy of PMX-60056

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Risk of hereditary form of bowel cancer: New preparation of omega-3 holds hope

Positive preliminary results from MediciNova's Phase Ib clinical trial of MN-221 for COPD

Purified form of omega 3 curbs precancerous bowel polyps

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Genentech submits ACTEMRA sBLA to FDA

Booster shot appears to improve TB resistance in previously vaccinated adults

Acetaminophen safe and effective for reducing postpartum pain

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Blocking RhoA enzyme increases survival in SMA mouse model

'Molecular band-aid' may help protect hearts of Duchenne muscular dystrophy patients

Genzyme, Isis Pharmaceuticals: Phase 3 study of mipomersen in hoFH patients meets primary endpoint

Why use light scattering to analyze proteins and viral vectors?

Changing the landscape of R&D to build clinical success from the ground up

Sensing a Healthier Future

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