Efficacy News and Research

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Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

18 Oct 2010

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood.

15 Oct 2010

Genentech and Biogen Idec announce positive results from ocrelizumab phase II RRMS study

Genentech, Inc., a member of the Roche Group, and Biogen Idec today announced 24-week results from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate.

15 Oct 2010

NovaBay to present two poster presentations at IDSA Annual Meeting

NovaBay Pharmaceuticals, Inc. a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces that it will deliver two poster presentations on its compounds at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA).

15 Oct 2010

Startech, STRCIC invest $2.5 million in ViroXis Corporation

Startech and the South Texas Regional Center of Innovation and Commercialization (STRCIC) today announced the investment of $2.5 million in San Antonio-based ViroXis Corporation by the Texas Emerging Technology Fund (TETF).

15 Oct 2010

FibroGen announces initiation of FG-3019 phase 2 study for reversing liver fibrosis

FibroGen, Inc. today announced initiation of a phase 2 study to compare the efficacy of FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), with placebo in reversing liver fibrosis (scarring of the liver) due to chronic infection with hepatitis B virus (HBV).

15 Oct 2010

Genzyme reports five-year patient data from Phase 2 multiple sclerosis trial

Genzyme Corporation today reported five-year patient data from its completed Phase 2 multiple sclerosis (MS) trial. This sub-group analysis found that nearly 90 percent of alemtuzumab-treated patients were free of sustained accumulation of disability, and that patients receiving alemtuzumab also maintained improved mean disability scores and a low risk of relapse over the 60-month follow-up period.

15 Oct 2010

VertiFlex enrolls patients in Superion IDE clinical trial

VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 200 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).

15 Oct 2010

IsoRay initiates study of Cesium-131 brachytherapy seeds for NSCLC cancer

IsoRay, Inc. announced today the initiation of a multi-institutional study of Cesium-131 brachytherapy seeds (internal radiation therapy) for use in Non Small Cell Lung Cancers (NSCLC). A number of institutions and physicians will be working to collect scientific data to further the use of Cesium-131 internal radiation therapy in conjunction with surgery for NSCLC.

14 Oct 2010

Workshop to focus on FDA process that grants orphan drug designation

The U.S. Food and Drug Administration has scheduled the third in a series of workshops on orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process for Nov. 4-5, 2010, in Lansdowne, Va.

14 Oct 2010

NIH awards grant to Bavarian to advance early research in filoviruses

Bavarian Nordic A/S announced today that the company has received funding from the U.S. National Institutes of Health (NIH) to advance its early research in filoviruses (Ebola and Marburg virus).

14 Oct 2010

XenoPort to present XP23829 preclinical data at ECTRIMS meeting

XenoPort, Inc. announced today that it will present data on a new preclinical product candidate, XP23829, at the upcoming 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Gothenburg, Sweden, October 13 - 16, 2010.

14 Oct 2010

Study finds wide variability in use of blood transfusions for coronary artery bypass graft surgery

A study that includes data on more than 100,000 patients who underwent coronary artery bypass graft surgery finds that there is wide variability among hospitals in the U.S. on the use of blood transfusions, without a large difference in the rate of death, suggesting that many transfusions may be unnecessary, according to a study in the October 13 issue of JAMA. Another study in this issue of JAMA examines the effect of a restrictive transfusion strategy on outcomes after cardiac surgery.

13 Oct 2010

Researchers investigate statin drugs to treat lung disease

Researchers at Queen's University Belfast are investigating a potential new treatment for lung disease that could save many lives each year. The research team is studying how statins, drugs which are commonly used to treat high cholesterol, can be used to treat lung disease.

13 Oct 2010

Pharmalink's Nefecon for IgA nephropathy receives FDA orphan drug designation

Pharmalink AB, a privately held Swedish pharmaceutical company, has received orphan drug designation by the US Food and Drug Administration (FDA) for its product candidate Nefecon (PL-56) for patients with IgA nephropathy, also referred to as Berger's Disease. This program is presently in clinical development phase II.

13 Oct 2010

Buprenorphine implant decreases opioid usage in persons with opioid dependence

Helping to address the issue of medication adherence, persons with opioid dependence who had the medication buprenorphine implanted had less opioid use over 16 weeks, according to a study in the October 13 issue of JAMA.

13 Oct 2010

Pycnogenol effective in relieving tinnitus symptoms: Study

More than 50 million Americans will experience some degree of tinnitus in their lifetime, according to the American Tinnitus Association. Tinnitus is a hearing condition that causes the constant misperception of sound, including hissing, ringing and rushing noises. A study recently published in Panminerva Medica reveals that Pycnogenol (pic-noj-en-all), an antioxidant plant extract derived from the bark of the French maritime pine tree, is effective in relieving tinnitus symptoms by improving blood flow in the inner ear.

13 Oct 2010

Imprime PGG and cetuximab increase overall response rate in metastatic colorectal cancer

A combination of Biothera's Imprime PGG and cetuximab (Erbitux) doubled the overall response rates for second- and third-line metastatic colorectal cancer patients participating in a Phase Ib/IIa clinical trial. The completed trial results were released yesterday at the 35th European Society for Medical Oncology (ESMO) Congress.

13 Oct 2010

Threshold announces TH-302 Phase 1/2 clinical trial interim results

Threshold Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 1/2 clinical trial in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented at the European Society for Medical Oncology (ESMO) Annual Meeting being held in Milan, Italy.

13 Oct 2010

Kennedy Krieger Institute launches phase II clinical trial to investigate Revatio for DMD treatment

Kennedy Krieger Institute announced today the launch of a first‐of‐its‐kind, phase II clinical trial to investigate a treatment for heart disease in individuals with Duchenne muscular dystrophy (DMD).

13 Oct 2010