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Landmark study compares oral and transvaginal NOTES to traditional laparoscopy

As part of the only U.S. prospective multicenter clinical trial to compare natural orifice translumenal endoscopic surgery to laparoscopy, surgeons at the University of California, San Diego School of Medicine have performed the trial's first oral gallbladder removal. This landmark study will evaluate whether or not NOTES is safe and as effective as traditional laparoscopic surgery.

8 Jul 2010

FDA-approved bioidentical estrogens help women manage common symptoms of menopause

Women looking for the best method to manage common symptoms of menopause, like hot flashes and night sweats, may not have access to credible information, especially when it comes to understanding their estrogen therapy options. In fact, there are an array of celebrities and authors who are simply not qualified to give medical advice about managing menopause, yet they dominate the internet and media space simply because of their popularity.

8 Jul 2010

Clinical performance data of Cervista HPV HR presented at International Papillomavirus Conference

Hologic, Inc., a leading women's healthcare company, today announced that final data analysis from the first large-scale independent evaluation of clinical performance of Cervista HPV HR compared to Hybrid Capture 2, were presented in Montreal, Canada, at the 26th International Papillomavirus Conference. Cervista HPV HR is a diagnostic test for the detection of 14 high-risk human papillomavirus types.

8 Jul 2010

Seattle non-profit recommends 'national strategy' for improving U.S. foreign aid efficacy

"[T]he United States needs a national strategy to clarify the goals of foreign aid, trade policy consistent with those goals, an easier process for small businesses to participate and support for international education programs," according to a set of recommendations for improving the effectiveness of U.S. foreign aid assistance released Tuesday by the Seattle-based non-profit Global Washington, the Seattle Times reports.

8 Jul 2010

Review examines surgical and non-surgical treatments available for patients with knee arthritis

Middle-aged men and women with osteoarthritis of the knee now have more options than ever before for treatments that may allow them to remain active in the sports they love, according to a review published in the July 2010 issue of the Journal of the American Academy of Orthopaedic Surgeons.

8 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

Crooks defraud health care system with fake insurance plans and phony Medicare, Medicaid claims

"Massive unemployment and a changing health care system is creating a breeding ground for con artists." Fake health insurance is one of the "fastest growing scams." Advertisements for such products are "stapled to neighborhood telephone polls, flyers left on your car or maybe you'll get a phone call from someone who's selling health insurance at extremely low rates, as low as $29.99 a month in some cases, says Jim Quiggle of the Coalition Against Insurance Fraud. The sad truth is that often these bogus policies pay little or nothing on claims, leaving consumers with exorbitant medical bills" (Haley, 7/6).

8 Jul 2010

ISCO and Sankara Nethralaya collaborate to develop "CytoCor" stem cell-derived corneal tissue

International Stem Cell Corporation and Sankara Nethralaya, announced today commencement of a collaboration to develop ISCO's "CytoCor™" stem cell-derived corneal tissue. The goal is to use CytoCor to treat corneal blindness and vision impairment. "This is one more step in ISCO's stated plan of building its portfolio of therapeutic agents through strategic alliances throughout the world," said Chairman, Ken Aldrich.

7 Jul 2010

PolyMedix receives NIH grant to develop defensin-mimetic antimicrobial compounds for malaria

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a grant from the National Institute of Health (NIH) to support the development of defensin-mimetic antimicrobial compounds for the treatment of malaria.

7 Jul 2010

Epeius Biotechnologies receives notice of allowance from USPTO for gene delivery platform

Epeius Biotechnologies Corporation, an emerging leader in the field of targeted genetic medicine, received a notice of allowance from the USPTO for another crucial patent covering its leading tumor-targeted gene delivery platform. The issuance of this high-value patent protection for targeting metastatic disease follows on the heels of two major patent issuances covering tumor-targeted gene delivery and precision-targeted cancer immunotherapy, respectively.

7 Jul 2010

European Commission approves new indication for ORENCIA in combination with MTX for RA

Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.

7 Jul 2010

Molecular Templates enters into oncology drug discovery and translation research agreement with ImClone

Molecular Templates announced today that it has entered into a collaborative oncology drug discovery and translation research agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company.

7 Jul 2010

Initial Phase II study results of ofatumumab in patients with RRMS announced

Genmab A/S announced today positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis.

7 Jul 2010

MJFF teams up with EHE International to raise awareness of Parkinson's disease

The Michael J. Fox Foundation for Parkinson's Research is teaming up with EHE International to raise awareness of the fight against Parkinson's disease. For the month of July, EHE International has kindly donated a 115-square-foot window space at 10 Rockefeller Plaza to showcase the many ways ordinary citizens can support the Foundation through its grassroots fundraising arm, Team Fox.

7 Jul 2010

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

DBV Technologies (DBV), a biotech company specializing in food allergy with innovative products for diagnosis and treatment, announced today the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application. DBV Technologies will begin clinical investigation of its lead food allergy desensitization candidate, VIASKIN® PEANUT, for the desensitization to peanut allergy. The Company expects to commence recruitment of peanut allergy patients at several medical centers in the U.S. this month.

7 Jul 2010

Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

Experts show the continuing global impact of Framingham Heart Study

Few medical investigations have had the impact of the Framingham Heart Study. This study, started in 1948, was designed as a cohort, observational study of cardiovascular disease, then recognized as a growing health threat but now has emerged as much more. The Framingham Heart study came to revolutionize thinking about cardiovascular disease, change the study of epidemiology, and even force the biostatistics community to develop multivariate analysis.

7 Jul 2010

Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

Crux Biomedical®Inc. announced today that it has successfully enrolled the first patient in its Retrieve 2 pivotal U.S. IDE trial. The trial will evaluate the safety and efficacy of Crux's new Vena Cava Filter (VCF). The Crux VCF is a retrievable, implantable filter which is designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). It is the first VCF to be developed that is bidirectional and thus permits insertion or retrieval from either the femoral or jugular veins.

7 Jul 2010

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

PuraMed BioScience, announced today that a clinical study of LipiGesic M has been completed. The study design was a double blind, placebo controlled, multi-site study measuring the effectiveness of LipiGesic™ M for the treatment of acute migraine attacks. The next steps include completion of the manuscript, submission for publication in a peer-reviewed medical journal and actual publication. In an effort to maximize the potential for publication, an embargo has been placed on the disclosure of any of the results of this study.

7 Jul 2010

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment.

6 Jul 2010

Efficacy News and Research

Landmark study compares oral and transvaginal NOTES to traditional laparoscopy

FDA-approved bioidentical estrogens help women manage common symptoms of menopause

Clinical performance data of Cervista HPV HR presented at International Papillomavirus Conference

Seattle non-profit recommends 'national strategy' for improving U.S. foreign aid efficacy

Review examines surgical and non-surgical treatments available for patients with knee arthritis

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

Crooks defraud health care system with fake insurance plans and phony Medicare, Medicaid claims

ISCO and Sankara Nethralaya collaborate to develop "CytoCor" stem cell-derived corneal tissue

PolyMedix receives NIH grant to develop defensin-mimetic antimicrobial compounds for malaria

Epeius Biotechnologies receives notice of allowance from USPTO for gene delivery platform

European Commission approves new indication for ORENCIA in combination with MTX for RA

Molecular Templates enters into oncology drug discovery and translation research agreement with ImClone

Initial Phase II study results of ofatumumab in patients with RRMS announced

MJFF teams up with EHE International to raise awareness of Parkinson's disease

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

Shire receives FDA approval of Daytrana for ADHD in adolescents

Experts show the continuing global impact of Framingham Heart Study

Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

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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