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FDA grants priority review status for Endo’s oxymorphone oral formulation

Endo Pharmaceuticals announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush resistant, has been granted priority review status.

23 Sep 2010

Weight-based taribavirin reduces anemia, increases sustained virologic response

Researchers at Cedars-Sinai Medical Center and 50 other centers found that weight-based dosing of taribavirin reduces rates of anemia while increasing sustained virologic response (SVR) in patients with chronic hepatitis C (HCV). Full details of this study are available in the October issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

23 Sep 2010

FDA approves Gilenya capsules for reducing MS relapses

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).

22 Sep 2010

Boehringer Ingelheim to present linagliptin Phase III data at 46th EASD

New Phase III data found that investigational linagliptin therapy resulted in significant reductions in blood sugar as measured by hemoglobin A1c (HbA1c) when compared to placebo, both when added to sulfonylurea (SU) in inadequately controlled type 2 diabetes (T2D) patients, and when administered as monotherapy in T2D patients for whom metformin is inappropriate.

22 Sep 2010

APF launches new educational initiative for people with pain, health care professionals

The American Pain Foundation today announced the launch of PainSAFE (Pain Safety & Access For Everyone), a new educational initiative designed for people with pain and health care professionals. The mission of PainSAFE is to provide education surrounding the appropriate and safe use of pain management therapies for people affected by pain and health care professionals, thereby, helping to reduce risk and improve access to quality pain care.

22 Sep 2010

G-CSF compound may activate virus, increases risk of infection: Research

Research conducted at Oregon Health & Science University's Vaccine and Gene Therapy Institute may spur debate about the risks associated with administering a specific compound in some forms of bone-marrow transplantation. The research is published in the current edition of Cell Host and Microbe.

22 Sep 2010

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus.

22 Sep 2010

Researchers investigate performance levels of resident and staff physicians

Research on the quality of US resident physician performance levels has often been limited by lack of a comparison group or strict focus on specific diseases and geographical areas. In order to gain insight on differences in quality of care provided by resident physicians versus staff physicians, Boston Medical Center and Palo Alto Medical Foundation researchers investigated performance of physicians in 33,900 hospital-based outpatient visits throughout the US.

22 Sep 2010

Communication breakdown exists between people with chronic pain, health care providers: Survey

Conversations with health care providers can be challenging at times for all patients, but a new survey commissioned by HealthyWomen and conducted by Synovate Healthcare in July of 2010 reveals a concerning communications breakdown between people with chronic pain and their health care providers. More than one-third of chronic pain sufferers (36%) have simply learned to live with their often debilitating pain and may be reluctant to speak with a health care provider about their condition, according to a survey of women and men with chronic pain released today.

22 Sep 2010

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

Patient follow-up complete in SANUWAVE's dermaPACE Phase III IDE trial for diabetic foot ulcers

SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in regenerative medicine, today announced the completion of patient follow-up in the Company's pivotal Phase III, Investigational Device Exemption (IDE) clinical trial with dermaPACE™ for the treatment of diabetic foot ulcers.

22 Sep 2010

Prevalence of periodontal disease in US higher than originally estimated

The prevalence of periodontal disease in the United States may be significantly higher than originally estimated. Research published in the Journal of Dental Research from the Centers for Disease Control and Prevention (CDC) and the American Academy of Periodontology (AAP) suggests that the prevalence of periodontal disease may have been underestimated by as much as 50 percent. The implication is that more American adults may suffer from moderate to severe gum disease than previously thought.

22 Sep 2010

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Apricus Biosciences, backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud's syndrome secondary to scleroderma.

22 Sep 2010

Health overhaul details trigger uncertainty, debate

The Orlando Sentinel: "It's one of the most overlooked pieces of health-care overhaul, but a plan to help companies pay health-care costs for early retirees has proved popular in Florida, where 69 companies and government agencies have applied for federal help.

22 Sep 2010

Biodegradable polymers represent future of stent design

Three-year data demonstrated that satisfactory clinical and safety outcomes of sirolimus eluting stents with a biodegradable polymer were sustained in a real world setting. The results were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

21 Sep 2010

HHS awards ICF International $11.7M contract under CDC task order

ICF International, a leading provider of consulting services and technology solutions to government and commercial clients, has been awarded a new $11.7 million contract by the U.S. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC). The contract has a term of three years. The contract is awarded under a CDC National Center for Birth Defects and Developmental Disabilities ID/IQ task order.

21 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

ProtAffin presents impressive efficacy data for PA401 in COPD

ProtAffin AG, a biotechnology company developing a novel class of biopharmaceutical products that act by targeting cell-surface glycan structures, today presents compelling preclinical data in chronic obstructive pulmonary disease (COPD) for its lead product PA401 at the European Respiratory Society Congress in Barcelona, Spain. This conference is the largest gathering of scientists and clinicians in the respiratory community in the world. The Oral Presentation will be made in the session "Pre-clinical models of airways disease".

21 Sep 2010

Voice disorders are not benign nuisances that go away

Two-thirds of Americans with voice problems don't seek medical care either because they don't know treatment is available or because they think the problem will just go away, according to a new study conducted at the Duke Voice Care Center.

21 Sep 2010

Nonin Medical launches new pulse oximetry products at ERS 2010 Annual Congress

Nonin Medical, Inc., a leading innovator of noninvasive physiological monitoring solutions, today introduced new pulse oximetry products, a new clinical guidebook and a new European sales, distribution and customer service center at the European Respiratory Society (ERS) 2010 Annual Congress in Barcelona, Spain.

21 Sep 2010