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Merck announces interim analysis from V710 Phase II/III trial in S. aureus infection

Merck, known as MSD outside the United States and Canada, and Intercell AG today announced that following a pre-specified interim analysis from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus infection, the independent Data Monitoring Committee recommended suspension of enrollment.

11 Apr 2011

Gilenya can reduce risk of disability progression in patients with RRMS

A new analysis demonstrated that Gilenya reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history. This analysis of the phase III two-year FREEDOMS study is one of 11 abstracts on Gilenya being presented at the 63rd annual meeting of the American Academy of Neurology.

11 Apr 2011

Scientists identify new treatment to combat PFAPA syndrome in children

A preliminary study conducted by a team at the National Institutes of Health has identified a promising new treatment in children for the most common form of a rare disorder.

11 Apr 2011

IDSA, U.S. health officials describe ways to respond to global threat of antimicrobial resistance

To coincide with World Health Day on Thursday, the Infectious Diseases Society of America (IDSA) released a policy paper with nine recommendations for how to control the "ever-growing threat of antimicrobial resistance," CIDRAP News reports.

11 Apr 2011

Investigational drug effective for patients with obesity

An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.

11 Apr 2011

FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

Antares Pharma, Inc. today announced the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel incorporating Antares' ATD Gel technology.

8 Apr 2011

An essential 'cookbook' for clinical trials

For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with.

8 Apr 2011

NEJM: Perspectives from Aaron, Reinhardt, Iglehart, Annas, Chambers and others

This week's New England Journal of Medicine features perspectives from prominent authors on Medicare and Medicaid. NEJM granted KHN permission to excerpt substantial portions of these columns.

8 Apr 2011

Long-term delivery of CNTF slows loss of visual acuity caused by geographic atrophy

A phase 2 clinical trial for the treatment of a severe form of age-related macular degeneration called geographic atrophy (GA) has become the first study to show the benefit of a therapy to slow the progression of vision loss for this disease. The results highlight the benefit of the use of a neurotrophic factor to treat GA and provide hope to nearly one million Americans suffering from GA.

8 Apr 2011

Physician's documentation confirms successful treatment of basal cell carcinoma with topical cannabis extract

Cannabis Science, Inc., US biotech company developing pharmaceutical cannabis products. On March 9, 2011 Cannabis Science announced that we would follow up our press release with medical documentation regarding the effectiveness of our cannabis extracts for treating skin cancer as was documented photographically in our earlier press release of February 22, 2011.

7 Apr 2011

DSP, BBI sign license agreement for BBI608

Dainippon Sumitomo Pharma Co., Ltd. and Boston Biomedical, Inc., today announced that they have signed a Product Option License Agreement for BBI608 for all oncology indications in Japan and exclusive right of negotiation for BBI608 for the United States and Canada.

7 Apr 2011

Southwest Oncology Group is now 'SWOG'

The Southwest Oncology Group is now simply "SWOG."

7 Apr 2011

FDA approves Horizant Extended-Release Tablets for Restless Legs Syndrome

GlaxoSmithKline and XenoPort, Inc. announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night.

7 Apr 2011

Progesterone gel can reduce preterm birth in women with short cervix

A groundbreaking clinical study of a new method for preventing premature birth in millions of women each year, published in the medical journal Ultrasound in Obstetrics & Gynecology, shows that the rate of early preterm delivery in women can be reduced by 45 percent - simply by treating pregnant women at risk with a low-cost gel of natural progesterone during the midtrimester of pregnancy until term.

7 Apr 2011

New PSA test identifies men with prostate cancer more accurately

In a large multi-center clinical trial, a new PSA test to screen for prostate cancer more accurately identified men with prostate cancer -- particularly the aggressive form of the disease -- and substantially reduced false positives compared to the two currently available commercial PSA tests, according to newly published research from Northwestern Medicine.

7 Apr 2011

Avila announces successful completion of AVL-292 Phase 1a clinical studies for B-cell cancers

Avila Therapeutics, Inc., a biotechnology company developing novel targeted covalent drugs, today announced that it has successfully completed two Phase 1a clinical studies for AVL-292, its orally-available, selective inhibitor of Bruton's tyrosine kinase (Btk).

6 Apr 2011

ImClone Systems initiates IMC-3C5 Phase 1 trial in patients with advanced solid tumours

Circadian Technologies announced today that its licensee ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, has advised that it has commenced the first Phase 1 clinical trial of its fully-human monoclonal antibody IMC-3C5.

6 Apr 2011

Aptiv Solutions creates Adaptive Clinical Trials Innovation Center

Aptiv Solutions, a global biopharmaceutical and medical device development services company, announced today the creation of an Adaptive Clinical Trials Innovation Center.

6 Apr 2011

J&JPRD announces rivaroxaban Phase 3 trial results against venous thromboembolism

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced results from the MAGELLAN Phase 3 trial evaluating the investigational oral anticoagulant rivaroxaban for the prevention of venous thromboembolism in hospitalized patients with acute medical illnesses.

6 Apr 2011

Device to treat resistant hypertension lowers blood pressure by 33 points

A device designed to treat people with resistant hypertension helped lower blood pressure by 33 points, a substantial drop that would otherwise require patients to take an additional three or four drugs, on top of this subgroup's usual regimen of up to five drugs, to control their difficult-to-treat condition.

6 Apr 2011

Clinical Trial News and Research

Merck announces interim analysis from V710 Phase II/III trial in S. aureus infection

Gilenya can reduce risk of disability progression in patients with RRMS

Scientists identify new treatment to combat PFAPA syndrome in children

IDSA, U.S. health officials describe ways to respond to global threat of antimicrobial resistance

Investigational drug effective for patients with obesity

FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

An essential 'cookbook' for clinical trials

NEJM: Perspectives from Aaron, Reinhardt, Iglehart, Annas, Chambers and others

Long-term delivery of CNTF slows loss of visual acuity caused by geographic atrophy

Physician's documentation confirms successful treatment of basal cell carcinoma with topical cannabis extract

DSP, BBI sign license agreement for BBI608

Southwest Oncology Group is now 'SWOG'

FDA approves Horizant Extended-Release Tablets for Restless Legs Syndrome

Progesterone gel can reduce preterm birth in women with short cervix

New PSA test identifies men with prostate cancer more accurately

Avila announces successful completion of AVL-292 Phase 1a clinical studies for B-cell cancers

ImClone Systems initiates IMC-3C5 Phase 1 trial in patients with advanced solid tumours

Aptiv Solutions creates Adaptive Clinical Trials Innovation Center

J&JPRD announces rivaroxaban Phase 3 trial results against venous thromboembolism

Device to treat resistant hypertension lowers blood pressure by 33 points

Achieving and maintaining ISO 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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